RecruitingPhase 2NCT05844644

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

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


Sponsor

Golo

Enrollment

100 participants

Start Date

Apr 20, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the GOLO for Life diet plan, combined with a supplement called Release, can help people with prediabetes or type 2 diabetes manage their blood sugar and lose weight more effectively. **You may be eligible if...** - You are between 18 and 75 years old - You have a BMI of 25 or higher (overweight or obese) - You have prediabetes or type 2 diabetes - You are postmenopausal or have had a procedure that prevents pregnancy (if female), or are willing to use reliable contraception - You are willing to follow the study diet and take the supplement as directed **You may NOT be eligible if...** - You use insulin to manage your diabetes - You are pregnant, breastfeeding, or planning to become pregnant - You have had significant recent weight changes or weight loss surgery - You have serious heart, liver, kidney, or thyroid conditions - You have a history of an eating disorder - You are currently taking certain medications that could interfere with blood sugar management Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTRelease

One capsule of Release will be taken three times per day for 180 days in combination with the G4LP.


Locations(2)

One Retreat Wellness

LaSalle, Ontario, Canada

KGK Science Inc.

London, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT05844644


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