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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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The objective of this study is to investigate the efficacy and safety of the GOLO for Life® Plan (G4LP) and Release supplementation on weight loss, body composition, and cardiometabolic parameters in overweight and obese adults. The change from baseline at Days 90 and 180 following the G4LP and supplementation with Release in weight (kg and % of total weight) and fat mass (percent and kg) will be assessed by Dual X-Ray Absorptiometry (DEXA). The weekly change in weight (kilograms and percent change) will also be assessed from baseline to day 180 following the G4LP and Release supplementation. Additionally, the safety and tolerability of the G4LP and Release supplementation will be measured by the occurrence of and/or changes in pre-emergent and post-emergent adverse events (AEs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golo for Life® Plan(G4LP) and Release Supplement | Experimental | Participants will be instructed to use the resources provided and follow the G4LP for the duration of the study period. Participants will also take one capsule of Release three times a day, to be taken at the beginning of or during each meal, starting on Day 1. If a dose is missed before or during a meal, participants are instructed to take the dose as soon as they remember after the meal. Participants will be advised not to exceed three capsules daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Release | Dietary Supplement | One capsule of Release will be taken three times per day for 180 days in combination with the G4LP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in weight (kilograms) following the GOLO for Life® Plan (G4LP) and supplementation with Release. | Change in weight will be assessed by Dual X-Ray Absorptiometry (DEXA). | baseline, day 90, day 180 |
| The change in weight (percentage of total weight) following the GOLO for Life® Plan (G4LP) and supplementation with Release. | Change in weight will be assessed by Dual X-Ray Absorptiometry (DEXA). | baseline, day 90, day 180 |
| The change in fat mass (percent) following the GOLO for Life® Plan (G4LP) and supplementation with Release. | Change in fat mass will be assessed by Dual X-Ray Absorptiometry (DEXA). | baseline, day 90, day 180 |
| The change in fat mass (kilograms) following the GOLO for Life® Plan (G4LP) and supplementation with Release. | Change in fat mass will be assessed by Dual X-Ray Absorptiometry (DEXA). | baseline, day 90, day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| The change in body mass index (BMI) from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 | |
| The change in muscle mass (percent) as assessed by DEXA from baseline at Days 90 and 180 following the G4LP and supplementation with Release. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of pre-emergent and post-emergent adverse events (AE). | baseline to day 180 | |
| Clinically relevant changes in heart rate (HR)) after 180 days. | baseline to day 180 | |
Inclusion Criteria:
Males and females between the age of 18-65 years, inclusive, at screening
BMI between 25 and 39.9 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 prior to enrollment. Acceptable methods of birth control include:
Self-reported stable body weight defined as not having gained or lost more than 5 kg of body weight in the three months prior to baseline
Motivated and ability to comply with G4LP guidelines as assessed by a Self-Motivation Questionnaire at screening (see Appendix 16.2)
Agrees to maintain current lifestyle habits as much as possible throughout the study depending on ability to maintain the following: medications, supplements (unless excluded), and sleep
Willingness and ability to complete questionnaires, records, and diaries associated with the study, adhere to dietary and exercise guidelines, and to complete all clinic visits
Provided voluntary, written, informed consent to participate in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| One Retreat Wellness | LaSalle | Ontario | N9H 1S4 | Canada | ||
| KGK Science Inc. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D004322 | Drainage |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| baseline, day 90, day 180 |
| The change in android fat (percent) as assessed by DEXA from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in gynoid fat (percent) as assessed by DEXA from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in android/gynoid fat ratio as assessed by DEXA from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in sagittal abdominal diameter (SAD) from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in waist circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in hip circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in arm circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in thigh circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in waist-to-hip ratio from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in lipid levels from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | Lipid levels will be assessed by triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, low-density lipoprotein cholesterol (LDL-C), TC:HDL-C, TG:HDL-C, and LDL-C:HDL-C ratios | baseline, day 90, day 180 |
| The change in glycemic control as assessed by HbA1c from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in glycemic control as assessed by serum insulin from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in glycemic control as assessed by serum glucose from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in glycemic control as assessed by HOMA-IR from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in blood pressure from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | baseline, day 90, day 180 |
| The change in gastrointestinal symptoms from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | Gastrointestinal symptoms will be assessed by the Modified Gastrointestinal Symptoms Rating Scale (GSRS) | baseline, day 90, day 180 |
| The change in subjective sleep efficiency, sleep debt, and sleep difficulty from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | Changes in sleep will be assessed by the Healthy People Sleep Quality Index (HPSQI). | baseline, day 90, day 180 |
| The change in stress levels from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | Stress levels will be assessed by the Perceived Stress Scale (PSS) and salivary cortisol. | baseline, day 90, day 180 |
| The change in physical activity from baseline at Days 90 and 180 following the G4LP and supplementation with Release. | Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ). | baseline, day 90, day 180 |
| The weekly change in weight (kilogram) from baseline at Day 180 following the G4LP and supplementation with Release. | baseline to day 180 |
| The weekly change in weight (percentage) from baseline at Day 180 following the G4LP and supplementation with Release. | baseline to day 180 |
| Clinically relevant changes in aspartate aminotransferase (AST) after 180 days. |
| baseline to day 180 |
| Clinically relevant changes in alanine aminotransferase (ALT) after 180 days. | baseline to day 180 |
| Clinically relevant changes in alkaline phosphatase (ALP) after 180 days. | baseline to day 180 |
| Clinically relevant changes in total bilirubin after 180 days. | baseline to day 180 |
| Clinically relevant changes in creatinine after 180 days. | baseline to day 180 |
| Clinically relevant changes in electrolytes after 180 days. | Electrolytes to be measured include sodium, potassium, and chloride. | baseline to day 180 |
| Clinically relevant changes in estimated glomerular filtration rate (eGFR) after 180 days. | baseline to day 180 |
| Clinically relevant changes in white blood cell (WBC) count with differential after 180 days. | White blood cells to be measured include neutrophils, lymphocytes, monocytes, eosinophils, and basophils. | baseline to day 180 |
| Clinically relevant changes in red blood cell (RBC) count after 180 days. | baseline to day 180 |
| Clinically relevant changes in hemoglobin after 180 days. | baseline to day 180 |
| Clinically relevant changes in hematocrit after 180 days. | baseline to day 180 |
| Clinically relevant changes in platelet count after 180 days. | baseline to day 180 |
| Clinically relevant changes in immature granulocytes after 180 days. | baseline to day 180 |
| Clinically relevant changes in nucleated red blood cells (RBC) after 180 days. | baseline to day 180 |
| Clinically relevant changes in red blood cell (RBC) mean corpuscular volume (MCV) after 180 days. | baseline to day 180 |
| Clinically relevant changes in mean corpuscular hemoglobin (MCH) after 180 days. | baseline to day 180 |
| Clinically relevant changes in mean corpuscular hemoglobin concentration (MCHC) after 180 days. | baseline to day 180 |
| Clinically relevant changes in red blood cell distribution width (RDW) after 180 days. | baseline to day 180 |
| London |
| Ontario |
| N6B 3L1 |
| Canada |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |