NCT05844644

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Golo · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 2 Diabetes
• Obese
• Overweight
• Prediabetes

Interventions

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

Timeline

• Start date: 2023-04-20
• Primary completion: 2024-11-01
• Completion: 2025-01-01
• First posted: 2023-05-06
• Last updated: 2024-07-26

Locations

2 sites across 1 country: Canada