The Effects of the GOLO for Life® Plan and Release Supplement on Weight Management in Overweight and Obese Adults
NCT05844631 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83
Last updated 2024-02-12
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).
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Release
One capsule of Release will be taken three times per day for 180 days in combination with the G4LP.
Sponsors & Collaborators
-
KGK Science Inc.
collaborator INDUSTRY -
Golo
lead INDUSTRY
Principal Investigators
-
David Crowley, MD · KGK Science Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-04-20
- Primary Completion
- 2023-12-23
- Completion
- 2023-12-23
Countries
- Canada
Study Locations
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