Investigating the GOLO for Life® Plan and Release Supplement for Weight and Blood Sugar Control

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

This study is testing if the GOLO for Life® Plan and Release supplement can help overweight or obese adults with prediabetes or Type 2 diabetes manage their weight and blood sugar better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Golo (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (LaSalle, Ontario and 1 other locations)
• Trial ID: NCT05844644 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of the GOLO for Life® Plan (G4LP) combined with Release supplementation in managing glycemic control and weight in overweight and obese adults diagnosed with Prediabetes or Type 2 Diabetes. Participants will be assessed for changes in glycemic control from baseline at 90 and 180 days after starting the G4LP and supplementation. The study will also monitor the safety and tolerability of the intervention by tracking adverse events throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are overweight or obese adults aged 18-75 with Prediabetes or Type 2 Diabetes.

Not a fit: Patients who are not overweight or obese, or those with conditions other than Prediabetes or Type 2 Diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help improve blood sugar levels and promote weight loss in individuals with Prediabetes or Type 2 Diabetes.

How similar studies have performed: Other studies have shown promising results with lifestyle interventions and dietary plans for managing diabetes, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Males and females between the age of 18-75 years, inclusive, at screening
2. BMI ≥25 kg/m2
3. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening

   Or,

   Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months prior to enrollment. Acceptable methods of birth control include:
   * Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
   * Double-barrier method
   * Intrauterine devices
   * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
   * Vasectomy of partner at least 6 months prior to screening
   * Abstinence and agrees to use contraception if planning on becoming sexually active
4. Prediabetes or Type 2 Diabetes with HbA1c ≥6.0% to \<9% with stability of disease and no change in diabetic medication in the past three months, if applicable.
5. Self-reported stable body weight in the three months prior to baseline, as assessed by the QI
6. Motivated and ability to comply with G4LP guidelines as assessed by a Self-Motivation Questionnaire at screening (see Appendix 16.3)
7. Agrees to maintain current lifestyle habits as much as possible throughout the study depending on ability to maintain the following: medications, supplements (unless excluded), and sleep
8. Willingness and ability to complete questionnaires, records, and diaries associated with the study, adhere to dietary and exercise guidelines, and to complete all clinic visits
9. Provided voluntary, written, informed consent to participate in the study

Exclusion Criteria:

1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
2. Allergy, sensitivity, or intolerance to the investigational product ingredients
3. Type 1 diabetes
4. Type 2 diabetes if on insulin treatment
5. Gastric bypass surgery or other surgeries to induce weight loss
6. Current participation or participation within the last three months in any weight loss or diet programs
7. Current or history of eating disorders, as assessed by the QI
8. Obesity-induced by metabolic or endocrinologic disorders (ex. acromegaly, hypothalamic obesity), as assessed by the QI
9. Current or history of significant diseases of the gastrointestinal tract, as assessed by the QI
10. Chronic inflammatory diseases, as assessed by the QI
11. History of gout and have had a flare up within 12 months, as assessed by the QI
12. Current unstable diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
13. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
14. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
15. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
16. Current use of any prescribed or over-the counter medications and/or supplements that may affect glycemic control, body weight, or metabolism, as assessed by the QI
17. Regular use of tobacco products within 6 months of baseline and during the study period, as assessed by the QI
18. Chronic inhalation and edible use of cannabinoid products (\>1 time/month). Occasional users must agree to wash out and abstain during the study period
19. Alcohol intake average of \>2 standard drinks per day
20. Alcohol or drug abuse within the last 12 months
21. Clinically significant abnormal laboratory results at screening, as assessed by the QI
22. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
23. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
24. Individuals who are unable to give informed consent
25. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Where this trial is running

LaSalle, Ontario and 1 other locations

• One Retreat Wellness — LaSalle, Ontario, Canada (Recruiting)
• KGK Science Inc. — London, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: David Crowley, MD — KGK Science Inc.
• Study coordinator: Marc Moulin, PhD

Conditions Type 2 Diabetes; Obese; Overweight; Prediabetes; obese; overweight; glycemic control