Actively Recruiting
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
Led by Golo · Updated on 2024-07-26
100
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
G
Golo
Lead Sponsor
K
KGK Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of the GOLO for Life Plan (G4LP) combined with the Release supplement on blood sugar control and weight in overweight and obese adults who have Prediabetes or Type 2 Diabetes. This Phase 2 open-label study aims to assess changes in blood sugar markers and weight over 90 and 180 days, while also monitoring the safety and tolerability of the plan and supplement through tracking adverse events. Participants will follow the G4LP guidelines throughout the study and take one capsule of Release three times daily with or at the start of each meal for 180 days. If a dose is missed, it should be taken as soon as remembered after the meal, with a maximum of three capsules per day. The study does not include a control or placebo group, focusing on this combined intervention. During the study, participants will have their blood sugar levels measured by serum glucose, HbA1c, insulin, and HOMA-IR at baseline, day 90, and day 180. Weight and body measurements such as BMI, waist and hip circumference, and inflammatory markers will also be tracked, alongside quality of life assessments. Participants will complete questionnaires, diaries, and clinic visits to monitor adherence and health changes over the six-month period.
CONDITIONS
Brief 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 18 and 75 years old at screening
- Body mass index (BMI) of 25 kg/m2 or higher
- Females not of child-bearing potential or females of child-bearing potential with a negative pregnancy test and agreement to use approved birth control during the study
- Diagnosed with Prediabetes or Type 2 Diabetes with HbA1c between 6.0% and less than 9%, stable disease and no change in diabetic medication in past 3 months
- Stable body weight in the 3 months prior to baseline
- Motivated and able to comply with the GOLO for Life Plan guidelines
- Agree to maintain current lifestyle habits, including medications, supplements (unless excluded), and sleep
- Willing to complete study questionnaires, records, diaries, and clinic visits
- Provide voluntary, written informed consent to participate
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Allergy, sensitivity, or intolerance to ingredients of the investigational product
- Type 1 diabetes
- Type 2 diabetes requiring insulin treatment
- History of gastric bypass or other weight loss surgeries
- Participation in weight loss or diet programs within last 3 months
- Current or past eating disorders
- Obesity caused by metabolic or endocrine disorders (e.g., acromegaly, hypothalamic obesity)
- Significant gastrointestinal diseases
- Chronic inflammatory diseases
- History of gout flare in past 12 months
- Unstable kidney or liver disease except symptom-free kidney stones for 6 months
- Current or past thyroid conditions unless stable on medication for 3 months
- Major surgery in past 3 months or planned during study
- History of cancer except treated skin basal cell carcinoma or cancer in remission over 5 years
- Use of medications or supplements affecting glycemic control, weight, or metabolism
- Regular tobacco use within 6 months prior or during study
- Chronic use of cannabinoid products more than once per month
- Alcohol intake averaging more than 2 standard drinks per day
- Alcohol or drug abuse within past 12 months
- Abnormal lab results at screening
- Blood donation within 30 days prior or planned within 30 days after study
- Participation in other clinical trials within 30 days prior
- Unable to provide informed consent
- Any other condition or lifestyle factor that may affect ability to complete study or pose risk as judged by investigator or qualified individual
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 180 days
Participants take one capsule of the Release supplement three times daily and follow the GOLO for Life® Plan for 180 days.
3 visits (baseline, Day 90, and Day 180)
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
K
KGK Science Inc.
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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