An Open Label Study Evaluating 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
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
• 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
• Prediabetes or Type 2 Diabetes with HbA1c ≥6.0% to \<9% with stability of disease and no change in diabetic medication in the past three months, if applicable.
• Self-reported stable body weight in the three months prior to baseline, as assessed by the QI
• Motivated and ability to comply with G4LP guidelines as assessed by a Self-Motivation Questionnaire at screening (see Appendix 16.3)
• 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