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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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The present study will investigate the effects of Nic's Ketogenic diet, comprised of 70% fat, 5% carbohydrate, and 25% protein on middle-aged males and females with mid-range elevated LDL. With the mixed evidence on the causative effect of LDL cholesterol on increased cardiovascular health risk, further studies are warranted to examine the relation of elevated LDL and other biomarkers of cardiovascular health in response to a lifestyle intervention. Furthermore, this study will investigate weight loss and body composition changes with adherence to this dietary intervention over a 140-day period. In this study the efficacy of Nic's Ketogenic diet on weight loss and biomarkers of cardiovascular health will be examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nic's Keto Diet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nic's Keto Diet | Other | Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet | The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70. | 70 days |
| Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet | The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70. | 70 days |
| Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet | The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140. | 140 days |
| Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet | The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140. | 140 days |
| Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet | Changes to weight as assessed by BMI was reported at baseline and compared to day 70. | 70 days |
| Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet | Changes to weight as assessed by BMI was reported at baseline and compared to day 140. | 140 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 140 Days | The change in inflammation, as assessed by the change in erythrocyte sedimentation rate (ESR) following Nic's Keto Diet was reported at 140 days. | 140 days |
| The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 140 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pre-emergent and Post-emergent Adverse Events | Number of pre-emergent and post-emergent adverse events (AEs) | 140 days |
| Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet |
Inclusion Criteria:
Provided voluntary, written, informed consent to participate in study
Males and females between 30 and 55 years of age
BMI between 20.0 to 29.9 kg/m2, inclusive
Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) Or,
Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include:
Subjects with mid-range (2.5-4.1mmol/L or 100-159 mg/dL) elevated LDL-C levels
Agrees to maintain current level of physical activity throughout the study
Willingness to complete all questionnaires, records, and diaries and assessments associated with the study and to complete all clinic visits.
Healthy as determined by medical history, laboratory results, and as assessed by Qualified Investigator (QI)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6A 5R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34918971 | Derived | Tzenios N, Lewis ED, Crowley DC, Chahine M, Evans M. Examining the Efficacy of a Very-Low-Carbohydrate Ketogenic Diet on Cardiovascular Health in Adults with Mildly Elevated Low-Density Lipoprotein Cholesterol in an Open-Label Pilot Study. Metab Syndr Relat Disord. 2022 Mar;20(2):94-103. doi: 10.1089/met.2021.0042. Epub 2021 Dec 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nic's Keto Diet | Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nic's Keto Diet | Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet | The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | percentage of body fat | 70 days |
|
140 days
During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nic's Keto Diet | Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nikolaos Tzenios | TRCGEN+ (managed by Trans Russian Co) | +447583902071 | Nicolas@trccolleges.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2019 | Mar 1, 2021 | Prot_SAP_000.pdf |
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Open-Label
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The change in inflammation, as assessed by the change in C-reactive protein (CRP) following Nic's Keto Diet was reported at 140 days. |
| 140 days |
| Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet | Changes to weight from baseline were reported and compared to day 28 following Nic's Keto Diet. | 28 days |
| Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet | Changes to weight from baseline were reported and compared to day 56 following Nic's Keto Diet. | 56 days |
| Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet | Changes to weight from baseline were reported and compared to day 84 following Nic's Keto Diet. | 84 days |
| Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet | Changes to weight from baseline were reported and compared to day 112 following Nic's Keto Diet. | 112 days |
| Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet | Changes to systolic blood pressure from baseline were reported and compared to day 28 following Nic's Keto Diet. | 28 days |
| Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet | Changes to systolic blood pressure from baseline were reported and compared to day 56 following Nic's Keto Diet. | 56 days |
| Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet | Changes to systolic blood pressure from baseline were reported and compared to day 84 following Nic's Keto Diet. | 84 days |
| Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet | Changes to systolic blood pressure from baseline were reported and compared to day 112 following Nic's Keto Diet. | 112 days |
| Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet | Changes to systolic blood pressure from baseline were reported and compared to day 140 following Nic's Keto Diet. | 140 days |
| Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet | Changes to total cholesterol were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L) | 28 days |
| Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet | Changes to triglyceride level were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L). | 28 days |
| Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet | Changes to HDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 28 days |
| Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet | Changes to LDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 28 days |
| Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet | Changes to total cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 56 days |
| Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet | Changes to triglyceride level from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 56 days |
| Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet | Changes to HDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 56 days |
| Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet | Changes to LDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 56 days |
| Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet | Changes to total cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 84 days |
| Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet | Changes to triglyceride level from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 84 days |
| Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet | Changes to HDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 84 days |
| Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet | Changes to LDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 84 days |
| Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet | Changes to total cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 112 days |
| Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet | Changes to triglyceride level from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 112 days |
| Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet | Changes to HDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 112 days |
| Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet | Changes to LDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 112 days |
| Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet | Changes to total cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 140 days |
| Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet | Changes to triglyceride level from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 140 days |
| Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet | Changes to HDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 140 days |
| Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet | Changes to LDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | 140 days |
| Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet | Changes to HbA1c were reported at baseline and compared to day 140 following Nic's Keto Diet. | 140 days |
| Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet | Changes to fasting glucose were reported at baseline and compared to day 140 following Nic's Keto Diet. | 140 days |
| Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet | Changes to free tri-iodothyronine (T3) were reported at baseline and compared to day 140 following Nic's Keto Diet. | 140 days |
| Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet | Changes to weight were reported from baseline and compared to day 70 following Nic's Keto Diet. | 70 days |
| Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet | Changes to weight were reported from baseline and compared to Day 140 following Nic's Keto Diet. | 140 days |
| Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet | Changes to systolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet. | 70 days |
| Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet | Changes to diastolic blood pressure were reported from baseline and compared to Day 28 following Nic's Keto Diet. | 28 days |
| Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet | Changes to diastolic blood pressure were reported from baseline and compared to Day 56 following Nic's Keto Diet. | 56 days |
| Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet | Changes to diastolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet. | 70 days |
| Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet | Changes to diastolic blood pressure were reported from baseline and compared to Day 84 following Nic's Keto Diet. | 84 days |
| Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet | Changes to diastolic blood pressure were reported from baseline and compared to Day 112 following Nic's Keto Diet. | 112 days |
| Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet | Changes to diastolic blood pressure were reported from baseline and compared to Day 140 following Nic's Keto Diet. | 140 days |
ECG reports will be analysed after 70 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded.
| 70 days |
| Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet | ECG reports will be analysed after 140 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded. | 140 days |
| Change in Heart Rate After 140 Days of Following Nic's Keto Diet | Changes in heart rate after 140 days of following Nic's Keto Diet and compared to baseline. | 140 days |
| Change in Body Mass Index (BMI) After 140 Days of Following Nic's Keto Diet | Change in Body Mass Index (BMI) after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Alanine Aminotransferase (ALT) After 140 Days of Following Nic's Keto Diet | Change in alanine aminotransferase (ALT) after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Aspartate Aminotransferase (AST) After 140 Days of Following Nic's Keto Diet | Change in aspartate aminotransferase (AST) after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Total Bilirubin After 140 Days of Following Nic's Keto Diet | Change in total bilirubin after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Creatinine After 140 Days of Following Nic's Keto Diet | Change in creatinine after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Sodium Electrolyte Levels After 140 Days of Following Nic's Keto Diet | Change in sodium electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Potassium Electrolyte Levels After 140 Days of Following Nic's Keto Diet | Change in potassium electrolyte levels after 140 days of following Nic's Keto Diet | 140 days |
| Change in Chloride Electrolyte Levels After 140 Days of Following Nic's Keto Diet | Change in chloride electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Phosphorus Electrolyte Levels After 140 Days of Following Nic's Keto Diet | Change in phosphorus electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Estimated Glomerular Filtration Rate (eGFR) After 140 Days of Following Nic's Keto Diet | Change in estimated glomerular filtration rate (eGFR) after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Amount of Neutrophils After 140 Days of Following Nic's Keto Diet | Change in amount of neutrophils after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Amount of Lymphocytes After 140 Days of Following Nic's Keto Diet | Change in amount of lymphocytes after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Amount of Monocytes After 140 Days of Following Nic's Keto Diet | Change in amount of monocytes after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Amount of Eosinophils After 140 Days of Following Nic's Keto Diet | Change in amount of eosinophils after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Amount of Basophils After 140 Days of Following Nic's Keto Diet | Change in amount of basophils after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Red Blood Cell (RBC) Count After 140 Days of Following Nic's Keto Diet | Change in red blood cell (RBC) count after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Hemoglobin Levels After 140 Days of Following Nic's Keto Diet | Change in hemoglobin levels after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Hematocrit Levels After 140 Days of Following Nic's Keto Diet | Change in hematocrit levels after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Platelet Count After 140 Days of Following Nic's Keto Diet | Change in platelet count after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Mean Corpuscular Volume (MCV) After 140 Days of Following Nic's Keto Diet | Change in mean corpuscular volume (MCV) after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Mean Corpuscular Hemoglobin (MCH) After 140 Days of Following Nic's Keto Diet | Change in mean corpuscular hemoglobin (MCH) after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Mean Corpuscular Hemoglobin Concentration (MCHC) After 140 Days of Following Nic's Keto Diet | Change in mean corpuscular hemoglobin concentration (MCHC) after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Red Cell Distribution Width (RDW) After 140 Days of Following Nic's Keto Diet | Change in red cell distribution width (RDW) after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Change in Mean Platelet Volume (MPV) After 140 Days of Following Nic's Keto Diet | Change in mean platelet volume (MPV) after 140 days of following Nic's Keto Diet compared to baseline. | 140 days |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet | The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | percentage of muscle mass | 70 days |
|
|
|
| Primary | Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet | The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | percentage of body fat | 140 days |
|
|
|
| Primary | Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet | The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | percentage of muscle mass | 140 days |
|
|
|
| Primary | Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet | Changes to weight as assessed by BMI was reported at baseline and compared to day 70. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | kg/m^2 | 70 days |
|
|
|
| Primary | Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet | Changes to weight as assessed by BMI was reported at baseline and compared to day 140. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | kg/m^2 | 140 days |
|
|
|
| Secondary | The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 140 Days | The change in inflammation, as assessed by the change in erythrocyte sedimentation rate (ESR) following Nic's Keto Diet was reported at 140 days. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mm/hr | 140 days |
|
|
|
| Secondary | The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 140 Days | The change in inflammation, as assessed by the change in C-reactive protein (CRP) following Nic's Keto Diet was reported at 140 days. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mg/L | 140 days |
|
|
|
| Secondary | Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet | Changes to weight from baseline were reported and compared to day 28 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | kg | 28 days |
|
|
|
| Secondary | Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet | Changes to weight from baseline were reported and compared to day 56 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | kg | 56 days |
|
|
|
| Secondary | Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet | Changes to weight from baseline were reported and compared to day 84 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | kg | 84 days |
|
|
|
| Secondary | Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet | Changes to weight from baseline were reported and compared to day 112 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | kg | 112 days |
|
|
|
| Secondary | Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet | Changes to systolic blood pressure from baseline were reported and compared to day 28 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mm Hg | 28 days |
|
|
|
| Secondary | Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet | Changes to systolic blood pressure from baseline were reported and compared to day 56 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mm Hg | 56 days |
|
|
|
| Secondary | Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet | Changes to systolic blood pressure from baseline were reported and compared to day 84 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mm Hg | 84 days |
|
|
|
| Secondary | Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet | Changes to systolic blood pressure from baseline were reported and compared to day 112 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mm Hg | 112 days |
|
|
|
| Secondary | Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet | Changes to systolic blood pressure from baseline were reported and compared to day 140 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mm Hg | 140 days |
|
|
|
| Secondary | Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet | Changes to total cholesterol were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L) | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 28 days |
|
|
|
| Secondary | Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet | Changes to triglyceride level were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 28 days |
|
|
|
| Secondary | Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet | Changes to HDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 28 days |
|
|
|
| Secondary | Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet | Changes to LDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 28 days |
|
|
|
| Secondary | Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet | Changes to total cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 56 days |
|
|
|
| Secondary | Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet | Changes to triglyceride level from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 56 days |
|
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|
| Secondary | Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet | Changes to HDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 56 days |
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| Secondary | Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet | Changes to LDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 56 days |
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| Secondary | Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet | Changes to total cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 84 days |
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| Secondary | Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet | Changes to triglyceride level from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 84 days |
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|
| Secondary | Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet | Changes to HDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 84 days |
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|
| Secondary | Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet | Changes to LDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 84 days |
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| Secondary | Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet | Changes to total cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 112 days |
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| Secondary | Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet | Changes to triglyceride level from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 112 days |
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|
| Secondary | Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet | Changes to HDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 112 days |
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| Secondary | Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet | Changes to LDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 112 days |
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| Secondary | Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet | Changes to total cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 140 days |
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| Secondary | Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet | Changes to triglyceride level from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 140 days |
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| Secondary | Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet | Changes to HDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 140 days |
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| Secondary | Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet | Changes to LDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L). | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 140 days |
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| Secondary | Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet | Changes to HbA1c were reported at baseline and compared to day 140 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | percent of Glycosylated Haemoglobin | 140 days |
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| Secondary | Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet | Changes to fasting glucose were reported at baseline and compared to day 140 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 140 days |
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| Secondary | Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet | Changes to free tri-iodothyronine (T3) were reported at baseline and compared to day 140 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | pmol/L | 140 days |
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| Secondary | Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet | Changes to weight were reported from baseline and compared to day 70 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | kg | 70 days |
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| Secondary | Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet | Changes to weight were reported from baseline and compared to Day 140 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | kg | 140 days |
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| Secondary | Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet | Changes to systolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mm Hg | 70 days |
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| Secondary | Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet | Changes to diastolic blood pressure were reported from baseline and compared to Day 28 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mm Hg | 28 days |
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| Secondary | Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet | Changes to diastolic blood pressure were reported from baseline and compared to Day 56 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mm Hg | 56 days |
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| Secondary | Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet | Changes to diastolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mm Hg | 70 days |
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| Secondary | Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet | Changes to diastolic blood pressure were reported from baseline and compared to Day 84 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mm Hg | 84 days |
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| Secondary | Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet | Changes to diastolic blood pressure were reported from baseline and compared to Day 112 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mm Hg | 112 days |
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| Secondary | Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet | Changes to diastolic blood pressure were reported from baseline and compared to Day 140 following Nic's Keto Diet. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mm Hg | 140 days |
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| Other Pre-specified | Number of Pre-emergent and Post-emergent Adverse Events | Number of pre-emergent and post-emergent adverse events (AEs) | Safety population | Posted | Number | events | 140 days |
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| Other Pre-specified | Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet | ECG reports will be analysed after 70 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded. | Safety population | Posted | Number | participants | 70 days |
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| Other Pre-specified | Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet | ECG reports will be analysed after 140 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded. | Safety population | Posted | Number | participants | 140 days |
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| Other Pre-specified | Change in Heart Rate After 140 Days of Following Nic's Keto Diet | Changes in heart rate after 140 days of following Nic's Keto Diet and compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | bpm | 140 days |
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| Other Pre-specified | Change in Body Mass Index (BMI) After 140 Days of Following Nic's Keto Diet | Change in Body Mass Index (BMI) after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | kg/m^2 | 140 days |
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| Other Pre-specified | Change in Alanine Aminotransferase (ALT) After 140 Days of Following Nic's Keto Diet | Change in alanine aminotransferase (ALT) after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | U/L | 140 days |
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| Other Pre-specified | Change in Aspartate Aminotransferase (AST) After 140 Days of Following Nic's Keto Diet | Change in aspartate aminotransferase (AST) after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | U/L | 140 days |
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| Other Pre-specified | Change in Total Bilirubin After 140 Days of Following Nic's Keto Diet | Change in total bilirubin after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | µmol/L | 140 days |
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| Other Pre-specified | Change in Creatinine After 140 Days of Following Nic's Keto Diet | Change in creatinine after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | µmol/L | 140 days |
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| Other Pre-specified | Change in Sodium Electrolyte Levels After 140 Days of Following Nic's Keto Diet | Change in sodium electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 140 days |
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| Other Pre-specified | Change in Potassium Electrolyte Levels After 140 Days of Following Nic's Keto Diet | Change in potassium electrolyte levels after 140 days of following Nic's Keto Diet | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 140 days |
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| Other Pre-specified | Change in Chloride Electrolyte Levels After 140 Days of Following Nic's Keto Diet | Change in chloride electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 140 days |
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| Other Pre-specified | Change in Phosphorus Electrolyte Levels After 140 Days of Following Nic's Keto Diet | Change in phosphorus electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mmol/L | 140 days |
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| Other Pre-specified | Change in Estimated Glomerular Filtration Rate (eGFR) After 140 Days of Following Nic's Keto Diet | Change in estimated glomerular filtration rate (eGFR) after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | 140 days |
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| Other Pre-specified | Change in Amount of Neutrophils After 140 Days of Following Nic's Keto Diet | Change in amount of neutrophils after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | x10^9 neutrophils/L | 140 days |
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| Other Pre-specified | Change in Amount of Lymphocytes After 140 Days of Following Nic's Keto Diet | Change in amount of lymphocytes after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | x10^9 lymphocytes/L | 140 days |
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| Other Pre-specified | Change in Amount of Monocytes After 140 Days of Following Nic's Keto Diet | Change in amount of monocytes after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | x10^9 monocytes/L | 140 days |
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| Other Pre-specified | Change in Amount of Eosinophils After 140 Days of Following Nic's Keto Diet | Change in amount of eosinophils after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | x10^9 eosinophils/L | 140 days |
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| Other Pre-specified | Change in Amount of Basophils After 140 Days of Following Nic's Keto Diet | Change in amount of basophils after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | x10^9 basophils/L | 140 days |
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| Other Pre-specified | Change in Red Blood Cell (RBC) Count After 140 Days of Following Nic's Keto Diet | Change in red blood cell (RBC) count after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | x10^12 RBC/L | 140 days |
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| Other Pre-specified | Change in Hemoglobin Levels After 140 Days of Following Nic's Keto Diet | Change in hemoglobin levels after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | g/L | 140 days |
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| Other Pre-specified | Change in Hematocrit Levels After 140 Days of Following Nic's Keto Diet | Change in hematocrit levels after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | l/l | 140 days |
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| Other Pre-specified | Change in Platelet Count After 140 Days of Following Nic's Keto Diet | Change in platelet count after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | x10^9 platelets/L | 140 days |
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| Other Pre-specified | Change in Mean Corpuscular Volume (MCV) After 140 Days of Following Nic's Keto Diet | Change in mean corpuscular volume (MCV) after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | fl | 140 days |
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| Other Pre-specified | Change in Mean Corpuscular Hemoglobin (MCH) After 140 Days of Following Nic's Keto Diet | Change in mean corpuscular hemoglobin (MCH) after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | pg | 140 days |
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| Other Pre-specified | Change in Mean Corpuscular Hemoglobin Concentration (MCHC) After 140 Days of Following Nic's Keto Diet | Change in mean corpuscular hemoglobin concentration (MCHC) after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | g/L | 140 days |
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| Other Pre-specified | Change in Red Cell Distribution Width (RDW) After 140 Days of Following Nic's Keto Diet | Change in red cell distribution width (RDW) after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | percentage of variation | 140 days |
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| Other Pre-specified | Change in Mean Platelet Volume (MPV) After 140 Days of Following Nic's Keto Diet | Change in mean platelet volume (MPV) after 140 days of following Nic's Keto Diet compared to baseline. | The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request. | Posted | Mean | Standard Deviation | fl | 140 days |
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|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 10 |
| 14 |
| Amenorrhoea | Endocrine disorders | Systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Haemoglobin decreased | Investigations | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Mood altered | Psychiatric disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Nervous system disorders | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | Systematic Assessment |
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| Oropharyngeal pain | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Vessel puncture site bruise | Vascular disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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The PI is an employee of the CRO that conducted the study. The research agreement indicates that the data is the property of the sponsor and therefore they control the option for disclosing results.