The Effects of the GOLO for Life® Plan With Release Supplement on Glycemic Control and Weight in Overweight and Obese Adults With Prediabetes or Type 2 Diabetes
Trial Parameters
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Males and females between the age of 18-75 years, inclusive, at screening 2. BMI ≥25 kg/m2 3. 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-h