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

Recruiting at 2 trial locations

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?

This trial examines the effectiveness of the GOLO for Life® Plan and a supplement named Release in managing blood sugar and weight in individuals with Prediabetes or Type 2 Diabetes. Researchers aim to determine if these strategies can safely improve blood sugar levels and aid in weight loss over approximately six months. The trial suits adults who are overweight, diagnosed with Prediabetes or Type 2 Diabetes, and have stable blood sugar levels without recent changes in their diabetes medication. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial does not specify that you must stop taking your current medications, but it does require that your diabetes medication has not changed in the past three months. You should maintain your current lifestyle habits, including medications, as much as possible during the study.

Is there any evidence suggesting that the GOLO for Life® Plan and Release supplementation are likely to be safe for humans?

Research shows that the Release supplement, part of the GOLO for Life® Plan, is generally safe. Over 100 studies have examined the ingredients in Release, supporting its safety and effectiveness. It is considered safe to use with other medications, including those for type 2 diabetes, and no prescription is needed. Previous studies suggest that Release is well-tolerated for long-term use. While these results are encouraging, this trial will further investigate its safety in people with prediabetes and type 2 diabetes. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for type 2 diabetes and obesity focus on managing blood sugar or reducing appetite through medication or lifestyle changes. But the GOLO for Life® Plan with Release supplement offers a unique approach by combining a structured lifestyle program with a natural supplement designed to improve insulin efficiency. Unlike standard medications that primarily target blood sugar levels directly, Release contains plant-based ingredients that work to balance insulin, potentially addressing a root cause of weight gain and blood sugar issues. Researchers are excited about this treatment because it promises a holistic solution that supports both weight loss and metabolic health in a natural way.

What evidence suggests that the GOLO for Life® Plan and Release supplementation could be effective for Type 2 Diabetes and Obesity?

Research has shown that the GOLO for Life® Plan and Release supplement, which participants in this trial will follow, can help people with type 2 diabetes manage their weight and blood sugar. One study found that participants lost an average of 7.9 pounds, and their BMI, a measure of body fat based on height and weight, dropped by 1.3 points. Additionally, their blood sugar control improved, as indicated by better Hemoglobin A1C levels, which reflect average blood sugar over a few months. The ingredients in the Release supplement have also been studied for their safety and benefits. These findings suggest that this program may effectively manage weight and blood sugar in people with type 2 diabetes or prediabetes. ^{1 3 6 7 8}

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05844644

Study Details | NCT05844644 | The Effects of the GOLO for ... This study investigates the GOLO for Life® Plan and Release supplement's effect on glycemic control and weight in overweight/obese adults with prediabetes or ...

2. golo.com golo.com/?srsltid=AfmBOoosjPCz9c46bLSpAtkt-HZMZ0m53ojmFKjCCloMSPxS9b9125e2

GOLO Weight Loss Program | GOLO For Life Recipes | GOLO Two clinical trials on GOLO and Release, as well as over 100 studies on the safety and efficacy of the ingredients in Release, support amazing health benefits.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03478202

Study Details | NCT03478202 | GOLO Open-Label Pilot 1 This open-label pilot study is intended to observe the effects of the program in a representative group of subjects with stable type 2 diabetes ...

4. biospace.com biospace.com/golo-llc-open-label-study-shows-impressive-results-in-patients-with-type-2-diabetes

GOLO, LLC Open Label Study Shows Impressive Results ... Overall weight loss averaged 7.9 lbs. (-3.8%) and BMI levels dropped by 1.3 (-3.7%). Markers of glycemic control improved with Hemoglobin A1C (- ...

5. researchgate.net researchgate.net/publication/335323367_A_randomized_double-blind_placebo-controlled_study_evaluating_the_effects_of_the_GOLO_weight_management_program_with_and_without_Release_supplement_on_weight_and_metabolic_parameters_in_subjects_with_

A randomized, double-blind, placebo-controlled study ... A randomized, double-blind, placebo-controlled study evaluating the effects of the GOLO weight management program with and without Release ...

6. golo.com golo.com/?srsltid=AfmBOopT3SOq63yjpZkC0u_dkASC1LXth8EI18CTkr3YmnZbH4J70753

GOLO Weight Loss Program | GOLO For Life Recipes | GOLO Two clinical trials on GOLO and Release, as well as over 100 studies on the safety and efficacy of the ingredients in Release, support amazing health benefits.

7. golo.com golo.com/products/golo-release?srsltid=AfmBOoqvuoGG9aLSAiR2Vfg-zu8zT6zBJ2cztoA2ZlVu7GnRtZ4g4qvo

GOLO Release Release is Safe and Effective. Safe to take with medications, even those for type 2 diabetes; Does not require a prescription and is safe for long-term use ...

8. withpower.com withpower.com/trial/phase-2-diabetes-mellitus-3-2023-1c606

GOLO for Life® Plan + Release for Type 2 Diabetes and ... This Phase 2 medical study run by Golo is evaluating whether Release will have tolerable side effects & efficacy for patients with Type 2 Diabetes, Obesity, ...