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

NCT05844644 | Recruiting Phase 2

• 1 other identifier: 22GLCFG02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Type 2 Diabetes; Obese; Overweight; Prediabetes

Keywords

Type 2 Diabetes; obese; overweight; glycemic control; Prediabetes

Outcome Measures

Primary Outcomes (6)

• 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

• 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

Secondary Outcomes (11)

• 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

Other Outcomes (20)

• 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

Study Arms (1)

GOLO for Life® Plan (G4LP) and Release Supplement

EXPERIMENTAL

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.

Dietary Supplement: Release

Interventions

Release DIETARY_SUPPLEMENT

One capsule of Release will be taken three times per day for 180 days in combination with the G4LP.

GOLO for Life® Plan (G4LP) and Release Supplement

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between the age of 18-75 years, inclusive, at screening
• BMI ≥25 kg/m2
• 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
• 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.
• Self-reported stable body weight in the three months prior to baseline, as assessed by the QI
• Motivated and ability to comply with G4LP guidelines as assessed by a Self-Motivation Questionnaire at screening (see Appendix 16.3)
• 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

You may not qualify if:

• Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
• Allergy, sensitivity, or intolerance to the investigational product ingredients
• Type 1 diabetes
• Type 2 diabetes if on insulin treatment
• Gastric bypass surgery or other surgeries to induce weight loss
• Current participation or participation within the last three months in any weight loss or diet programs
• Current or history of eating disorders, as assessed by the QI
• Obesity-induced by metabolic or endocrinologic disorders (ex. acromegaly, hypothalamic obesity), as assessed by the QI
• Current or history of significant diseases of the gastrointestinal tract, as assessed by the QI
• Chronic inflammatory diseases, as assessed by the QI
• History of gout and have had a flare up within 12 months, as assessed by the QI
• 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
• 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
• 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
• 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

Sponsors & Collaborators

• Golo: lead
• KGK Science Inc.: collaborator

Study Sites (2)

One Retreat Wellness

LaSalle, Ontario, N9H 1S4, Canada

RECRUITING

KGK Science Inc.

London, Ontario, N6B 3L1, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight; Prediabetic State

Interventions

Drainage

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Moulin, PhD

CONTACT

1-226-781-9094; mmoulin@kgkscience.com

KGK Science Inc.

CONTACT

participate@kgkscience.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 6, 2023
• Study Start: April 20, 2023
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

CA (2)