The objective of this study is to investigate the efficacy and safety of the GOLO for Life® Plan (G4LP) and Release supplementation on glycemic control and weight in overweight and obese adults with Prediabetes or Type 2 Diabetes. The change in glycemic control from baseline at Days 90 and 180 following the G4LP and supplementation with Release will be assessed. 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
100
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
RECRUITINGKGK Science Inc.
London, Ontario, Canada
RECRUITINGThe change in glycemic control as measured by serum glucose levels 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 measured 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 measured by 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 measured 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 glycemic control as measured by change in weight (kilograms) 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 measured by change in weight (percentage of total weight) from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
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 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.
Measures of lipid levels to be assessed include 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 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 inflammatory markers from baseline at days 90 and 180 following the G4LP and supplementation with Release.
Inflammatory markers to be measured include high sensitivity C-reactive protein (hsCRP), erythrocyte sedimentation rate (ESR), interleukin 6 (IL-6), and tumor necrosis factor alpha (TNF-α).
Time frame: baseline, day 90, day 180
The change in quality of life from baseline at days 90 and 180 following the G4LP and supplementation with Release.
Quality of life will be assessed by the RAND Corporation Short Form (SF)-36 questionnaire.
Time frame: baseline, day 90, day 180
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