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).
Males and females between the age of 18-75 years, inclusive, at screening
BMI ≥25 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
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)
Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, or intolerance to the investigational product ingredients
Type 1 diabetes
Type 2 diabetes if on insulin treatment
Single group
Release
Dietary supplementOne capsule of Release will be taken three times per day for 180 days in combination with the G4LP.
The change in glycemic control as measured by serum glucose levels from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
The change in glycemic control as measured by HbA1c from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
The change in glycemic control as measured by insulin from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
The change in glycemic control as measured by HOMA-IR from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
The change in body mass index (BMI) from baseline at days 90 and 180 following the G4LP and supplementation with Release.
The change in sagittal abdominal diameter (SAD) from baseline at days 90 and 180 following the G4LP and supplementation with Release.
The change in waist circumference from baseline at days 90 and 180 following the G4LP and supplementation with Release.
The change in hip circumference from baseline at days 90 and 180 following the G4LP and supplementation with Release.
The incidence of pre-emergent and post-emergent adverse events (AE).
Clinically relevant changes in heart rate (HR) after 180 days.
Clinically relevant changes in aspartate aminotransferase (AST) after 180 days.
Clinically relevant changes in alanine aminotransferase (ALT) after 180 days.
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Golo
Lead sponsor
KGK Science Inc.
Collaborator
