The Effects of the GOLO for Life® Plan and Release Supplement on Weight Management in Overweight and Obese Adults

Study Overview
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Brief Summary
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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).

Official Title
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An Open-label Study Evaluating the Effects of the GOLO for Life® Plan and Release Supplement on Weight Management in Overweight and Obese Adults

Conditions
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Obese, Overweight

Intervention / Treatment
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* Dietary Supplement: Release


Participation Criteria
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Eligibility Criteria
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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: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) Double-barrier method Intrauterine devices Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) Vasectomy of partner at least 6 months prior to screening Abstinence and agrees to use contraception if planning on becoming sexually active 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: Individuals who are pregnant, breast feeding, or planning to become pregnant during the study Allergy, sensitivity, or intolerance to the investigational product ingredients Gastric bypass surgery or other surgeries to induce weight loss Metal implants or other physical characteristics/limitations that may affect DEXA scan results, as assessed by the QI Current participation within the last three months in any weight loss or diet programs Current or history of eating disorders, as assessed by the QI Obesity-induced by metabolic or endocrinologic disorders (ex. acromegaly, hypothalamic obesity), as assessed by the QI Current or history of significant diseases of the gastrointestinal tract, as assessed by the QI Chronic inflammatory diseases, as assessed by the QI Type I diabetes Type 2 diabetes if on insulin treatment History of gout and have had a flare up within 12 months, as assessed by the QI Current unstable diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable Current use of any prescribed or over-the counter medications and/or supplements that may affect body weight or metabolism, as assessed by the QI Regular use of tobacco products within 6 months of baseline and during the study period, as assessed by the QI Chronic inhalation and edible use of cannabinoid products (>1 time/month). Occasional users must agree to wash out and abstain during the study period Alcohol intake average of >2 standard drinks per day Alcohol or drug abuse within the last 12 months Clinically significant abnormal laboratory results at screening, as assessed by the QI Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI Individuals who are unable to give informed consent Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Golo for Life® Plan(G4LP) and Release Supplement<br>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. | Dietary Supplement: Release<br>* One capsule of Release will be taken three times per day for 180 days in combination with the G4LP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, obese, weight loss, body composition, cardiometabolic parameters