CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 83 enrolled
Drug / intervention
Releasedietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05844631
NCT05844631Phase 2Completed

An Open-label Study Evaluating the Effects of the GOLO for Life® Plan and Release Supplement on Weight Management in Overweight and Obese Adults

Golo·interventional·Posted May 6, 2023·Updated Feb 12, 2024

In Brief

A Phase 2 clinical trial evaluating Release for Obese and Overweight. Completed, enrolled 83 participants across 2 sites.

Detailed Summary

The objective of this study is to investigate the efficacy and safety of the GOLO for Life® Plan (G4LP) and Release supplementation on weight loss, body composition, and cardiometabolic parameters in overweight and obese adults. The change from baseline at Days 90 and 180 following the G4LP and supplementation with Release in weight (kg and % of total weight) and fat mass (percent and kg) will be assessed by Dual X-Ray Absorptiometry (DEXA). The weekly change in weight (kilograms and percent change) will also be assessed from baseline to day 180 following the G4LP and Release supplementation. 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObese, Overweight
CountriesCanada
CollaboratorsKGK Science Inc.

Timeline

Phase 2CompletedFinished
202420252026
First PostedMay 6, 2023
Enrollment StartApr 20, 2023
Primary CompletionDec 23, 2023
TodayJul 1, 2026
Enrollment to primary: 8 monthsPosted 3.2 years ago

Interventions

Releasedietary

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