GOLO for Life® Plan + Release for Type 2 Diabetes and Obesity

Recruiting at 1 trial location

Overseen By KGK Science Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Golo

Must not be taking: Insulin, Glycemic control drugs

Disqualifiers: Pregnancy, Type 1 diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 90

Duration: 180 days

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

Adults aged 18-65 with Type 2 Diabetes, HbA1c levels between ≥6.5% to <9%, and a BMI of 25-39.9 kg/m2 can join this trial. They must have stable diabetes medication for the past three months, not be pregnant or planning pregnancy, maintain current lifestyle habits, and agree to use birth control if applicable.

Inclusion Criteria

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

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, 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

Exclusion Criteria

Current or history of eating disorders, as assessed by the QI

I am taking medications or supplements that could affect my blood sugar, weight, or metabolism.

I haven't had major surgery in the last 3 months and don't plan any during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow the GOLO for Life® Plan and take the Release supplement for the duration of the study

180 days

Visits at baseline, day 90, and day 180

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Release

Trial Overview The GOLO for Life Plan with Release supplement is being tested for its effectiveness on blood sugar control and weight loss in overweight adults with Type 2 Diabetes over a period of up to six months.

How Is the Trial Designed?

Group I: GOLO for Life® Plan (G4LP) and Release Supplement Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Golo

Lead Sponsor

Trials

5

Recruited

310+

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution