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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
83
One capsule of Release will be taken three times per day for 180 days in combination with the G4LP.
One Retreat Wellness
LaSalle, Ontario, Canada
KGK Science Inc.
London, Ontario, Canada
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: baseline, day 90, day 180
The change in body mass index (BMI) from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, day 90, day 180
The change in waist circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in hip circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in arm circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: baseline, day 90, day 180
The change in thigh circumference from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, day 90, day 180
The change in blood pressure from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: baseline, day 90, day 180
The weekly change in weight (kilogram) from baseline at Day 180 following the G4LP and supplementation with Release.
Time frame: baseline to day 180
The weekly change in weight (percentage) from baseline at Day 180 following the G4LP and supplementation with Release.
Time frame: baseline to day 180
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