Golo
Status and phase
Conditions
Treatments
About
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).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
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
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
There are currently no registered sites for this trial.
Central trial contact
KGK Science Inc.; Marc Moulin, PhD
Start date
Apr 20, 2023 • 2 years ago
End date
Nov 01, 2024 • 6 months ago
Today
May 02, 2025
Data sourced from clinicaltrials.gov
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