Actively Recruiting
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
Led by Golo · Updated on 2024-07-26
100
Participants Needed
2
Research Sites
88 weeks
Total Duration
On this page
Sponsors
G
Golo
Lead Sponsor
K
KGK Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females between the age of 18-75 years, inclusive, at screening
- Body mass index (BMI) 25 kg/m2 or higher
- Females not able to have children due to sterilization or post-menopause for at least 1 year
- Females able to have children must have a negative pregnancy test and agree to use approved birth control during the study
- Prediabetes or Type 2 Diabetes with HbA1c between 6.0% and less than 9%
- Stable body weight for the past 3 months
- Motivated and able to follow the GOLO for Life Plan guidelines
- Agree to maintain current lifestyle habits including medications, supplements (unless excluded), and sleep
- Willing and able to complete study questionnaires, records, diaries, and clinic visits
- Provided informed consent to participate in the study
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Allergy or intolerance to ingredients in the supplement
- Diagnosis of Type 1 diabetes
- Type 2 diabetes patients using insulin treatment
- Past gastric bypass or other weight loss surgeries
- Current or recent participation (within 3 months) in weight loss or diet programs
- Current or past eating disorders
- Obesity caused by metabolic or hormonal disorders
- Significant gastrointestinal diseases
- Chronic inflammatory diseases
- History of gout flare-ups within the last 12 months
- Unstable kidney or liver disease except symptom-free kidney stones for 6 months
- Current or past thyroid conditions unless on stable medication for at least 3 months
- Major surgery in past 3 months or planned during study
- Cancer except fully treated skin basal cell carcinoma or cancer in remission over 5 years
- Use of medications or supplements affecting blood sugar, weight, or metabolism
- Regular tobacco use within 6 months
- Frequent use of cannabinoid products more than once per month
- Alcohol intake averaging more than 2 standard drinks per day
- Alcohol or drug abuse within last 12 months
- Abnormal laboratory results at screening
- Blood donation within 30 days before baseline or planned within 30 days after last visit
- Participation in other clinical trials within 30 days before baseline
- Unable to give informed consent
- Any other condition or lifestyle factor that may interfere with study completion or safety as judged by the investigator QI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
One Retreat Wellness
LaSalle, Ontario, Canada, N9H 1S4
Actively Recruiting
2
KGK Science Inc.
London, Ontario, Canada, N6B 3L1
Actively Recruiting
Research Team
M
Marc Moulin, PhD
CONTACT
K
KGK Science Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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