GOLO for Life® Plan + Release for Type 2 Diabetes and Obesity

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byDavid Crowley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Golo

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Research Team

David Crowley, MD

Principal Investigator

KGK Science Inc.

Eligibility Criteria

Adults aged 18-65 with Type 2 Diabetes, HbA1c levels between ≥6.5% to <9%, and a BMI of 25-39.9 kg/m2 can join this trial. They must have stable diabetes medication for the past three months, not be pregnant or planning pregnancy, maintain current lifestyle habits, and agree to use birth control if applicable.

Inclusion Criteria

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

I am between 18 and 75 years old.

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Exclusion Criteria

Current or history of eating disorders, as assessed by the QI

I am taking medications or supplements that could affect my blood sugar, weight, or metabolism.

I haven't had major surgery in the last 3 months and don't plan any during the study.

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Treatment Details

Interventions

Release (Dietary Supplement)

Trial OverviewThe GOLO for Life Plan with Release supplement is being tested for its effectiveness on blood sugar control and weight loss in overweight adults with Type 2 Diabetes over a period of up to six months.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: GOLO for Life® Plan (G4LP) and Release SupplementExperimental Treatment1 Intervention

Participants will be instructed to use the resources provided and follow the G4LP for the duration of the study period. Participants will also take one capsule of Release three times a day, to be taken at the beginning of or during each meal, starting on Day 1. If a dose is missed before or during a meal, participants are instructed to take the dose as soon as they remember after the meal. Participants will be advised not to exceed three capsules daily.