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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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The goal of this clinical trial is to assess the absorption, safety, and efficacy of an NAD+ supplement in healthy adults. The main question it aims to answer is: What is the change in NAD+ levels in whole blood from baseline to day 56 between the NAD+ supplement and placebo? Researchers will compare the NAD+ supplement to placebo to evaluate its absorption, safety, and efficacy. Participants will be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAD+ | Experimental | Participants will be instructed to take two capsules daily after breakfast starting on Day 1 (day following baseline visit) until the day prior to their end of study visit. |
|
| Placebo | Placebo Comparator | Participants will be instructed to take two capsules daily after breakfast starting on Day 1 (day following baseline visit) until the day prior to their end of study visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAD+ | Dietary Supplement | Participants will be instructed to take two capsules daily after breakfast starting on Day 1 (day following baseline visit) until the day prior to their end of study visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NAD+ levels in whole blood from baseline to day 56 between the NAD+ supplement and placebo. | Change in NAD+ levels in whole blood from baseline to day 56 between the NAD+ supplement and placebo. | Day 0 to 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NAD+ levels in whole blood from baseline to days 14 and 28 between the NAD+ supplement and placebo. | Change in NAD+ levels in whole blood from baseline to days 14 and 28 between the NAD+ supplement and placebo. | Baseline to Days 14 and 28 |
| Change from baseline to days 28 and 56 between the NAD+ supplement and placebo in Cognitive function |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-emergent adverse events (AE) | Incidence of post-emergent adverse events (AE) | Screening (day -45 to day-15) to day 56 |
| Clinically relevant changes in blood pressure after supplementation |
Inclusion Criteria:
Males and females between 40 and 65 years of age, inclusive, at screening
Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Individuals 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. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
Willingness to complete questionnaires and diaries associated with the study and to complete all visits
Agrees to maintain current lifestyle habits (physical activity, medications, supplements, and sleep) as much as possible throughout the study
Agrees to follow the specified low NAD-precursor diet during the run-in period and throughout the study
Agrees to avoid caffeine (e.g., tea, coffee, energy drinks) for 12 hours (h) prior to post-screening in-clinic study visits
Agrees to avoid alcohol consumption and vigorous physical activity for 24 h prior to post-screening in-clinic study visits
Provided voluntary, written, informed consent to participate in the study
Healthy as determined by medical history and laboratory results as assessed by the Qualified Investigator (QI)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Lewis | Contact | +248 1-226-242-4551 | elewis@kgkscience.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Canada |
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| Placebo | Dietary Supplement | Participants will be instructed to take two capsules daily after breakfast starting on Day 1 (day following baseline visit) until the day prior to their end of study visit. |
|
Change from baseline to days 28 and 56 between the NAD+ supplement and placebo in cognitive function, as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Function- Short Form 8a. Raw scores range from 8 to 40, with higher scores indicating better perceived cognitive function. |
| Baseline to Days 28 and 56 |
| Change from baseline to days 28 and 56 between the NAD+ supplement and placebo in appearance and aesthetics | Change from baseline to days 28 and 56 between the NAD+ supplement and placebo in appearance and aesthetics, as assessed by the Appearance and Aesthetics Likert Scale. The Appearance and Aesthetic Likert Scale is a five-point Likert scale that assesses participant level of satisfaction with their appearance. The scales ranges from 1-not satisfied at all to 5-very satisfied. | Baseline to days 28 and 56 |
| Change from baseline to day 56 between the NAD+ supplement and placebo in energy and metabolism | Change from baseline to day 56 between the NAD+ supplement and placebo in energy and metabolism, as assessed by plasma adenosine triphosphate (ATP) production | Day 0 to 56 |
| Change from baseline to day 56 between the NAD+ supplement and placebo in cellular health and longevity | Change from baseline to day 56 between the NAD+ supplement and placebo in cellular health and longevity, as assessed by mitochondrial depolarization via 8-hydroxy-2'-deoxyguanosine (8OH-dG) | Day 0 to 56 |
| Change from baseline to day 56 between the NAD+ supplement and placebo in oxidative stress | Change from baseline to day 56 between the NAD+ supplement and placebo in oxidative stress, as assessed by reduced glutathione/glutathione disulfide (GSH/GSSG) ratio | Day 0 to 56 |
| Change from baseline to day 56 between the NAD+ supplement and placebo in cardiometabolic health | Change from baseline to day 56 between the NAD+ supplement and placebo in cardiometabolic health, as assessed by reactive hyperemia index (RHI) via EndoPAT machine | Day 0 to 56 |
Clinically relevant changes in blood pressure (mmHg) after supplementation
| Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in heart rate after supplementation | Clinically relevant changes in heart rate (beats per minute) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in aspartate aminotransferase | Clinically relevant changes in aspartate aminotransferase (U/L) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in alanine aminotransferase | Clinically relevant changes in alanine aminotransferase (U/L) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in alkaline phosphatase | Clinically relevant changes in alkaline phosphatase (U/L) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in total bilirubin | Clinically relevant changes in total bilirubin (micromole/litre) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in creatinine | Clinically relevant changes in creatinine (micromole/litre) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in sodium | Clinically relevant changes in sodium (mmol/L) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in potassium | Clinically relevant changes in potassium (mmol/L) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in chloride | Clinically relevant changes in chloride (mmol/L) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in estimated glomerular filtration rate | Clinically relevant changes in estimated glomerular filtration rate (mL/min/1.73 m^2) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in glucose | Clinically relevant changes in glucose (mmol/L) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in red blood cell count | Clinically relevant changes in red blood cell count (x 10^12/L) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in white blood cell count | Clinically relevant changes in white blood cell count (x 10^9/L) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in platelet count | Clinically relevant changes in platelet count (x 10^9/L) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in hemoglobin | Clinically relevant changes in hemoglobin (g/L) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in hematocrit | Clinically relevant changes in hematocrit (L/L) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in red blood cell indices (MCV - mean corpuscular volume) | Clinically relevant changes in MCV (fL) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in red blood cell indices (MCH - mean corpuscular hemoglobin) | Clinically relevant changes in MCH (pg) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in red blood cell indices (MCHC - mean corpuscular hemoglobin concentration) | Clinically relevant changes in MCHC (g/L) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in RDW - red cell distribution width | Clinically relevant changes in RDW (%) after supplementation | Screening (day -45 to day -15) to day 56 |
| Clinically relevant changes in red blood cell indices (MPV - mean platelet volume) | Clinically relevant changes in MPV (fL) after supplementation | Screening (day -45 to day -15) to day 56 |
| ID | Term |
|---|---|
| D009243 | NAD |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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