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 study identifier
interventional
100
1 country
2
Study Start
April 20, 2023
Actual (reported)Primary Completion
November 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 13, 2023
Actual (reported)April 20, 2023
Actual (reported)May 6, 2023
Actual (reported)November 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The change in glycemic control as measured by serum glucose levels from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
baseline, day 90, day 180
The change in glycemic control as measured by HbA1c from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
baseline, day 90, day 180
The change in glycemic control as measured by insulin from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
baseline, day 90, day 180
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.
One capsule of Release will be taken three times per day for 180 days in combination with the G4LP.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
One Retreat Wellness
LaSalle, Ontario, N9H 1S4, Canada
KGK Science Inc.
London, Ontario, N6B 3L1, Canada
David Crowley, MD
KGK Science Inc.
First Submitted
April 13, 2023
First Posted
May 6, 2023
Study Start
April 20, 2023
Actual (reported)Primary Completion
November 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The change in glycemic control as measured by HOMA-IR from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
baseline, day 90, day 180
The change in glycemic control as measured by change in weight (kilograms) from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
baseline, day 90, day 180
The change in glycemic control as measured by change in weight (percentage of total weight) from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
baseline, day 90, day 180
The change in body mass index (BMI) from baseline at days 90 and 180 following the G4LP and supplementation with Release.
baseline, day 90, day 180
The change in sagittal abdominal diameter (SAD) from baseline at days 90 and 180 following the G4LP and supplementation with Release.
baseline, day 90, day 180
The change in waist circumference from baseline at days 90 and 180 following the G4LP and supplementation with Release.
baseline, day 90, day 180
The change in hip circumference from baseline at days 90 and 180 following the G4LP and supplementation with Release.
baseline, day 90, day 180
The change in arm circumference from baseline at days 90 and 180 following the G4LP and supplementation with Release.
baseline, day 90, day 180
The incidence of pre-emergent and post-emergent adverse events (AE).
baseline to day 180
Clinically relevant changes in heart rate (HR) after 180 days.
baseline to day 180
Clinically relevant changes in aspartate aminotransferase (AST) after 180 days.
baseline to day 180
Contact the study team to confirm eligibility.
Study Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 26, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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