GOLO for Life® Plan + Release for Weight Management in Obesity

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byDavid Crowley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Golo

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a diet plan called GOLO for Life® (G4LP) combined with a supplement named Release. It aims to help overweight and obese adults lose weight and improve their health. The diet plan encourages healthy eating and lifestyle changes, while the supplement helps control hunger and boost metabolism.

Research Team

David Crowley, MD

Principal Investigator

KGK Science Inc.

Eligibility Criteria

Adults aged 18-65 with a BMI of 25-39.9, not pregnant or planning pregnancy, and non-smokers can join this weight management trial. They must be willing to follow the GOLO for Life Plan, use approved birth control if applicable, and have had stable body weight recently.

Inclusion Criteria

I am between 18 and 65 years old.

I cannot have children because I've had surgery or have been menopausal for over a year.

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; Self-reported stable body weight defined as not having gained or lost more than 5 kg of body weight in the three months prior to baseline; Motivated and ability to comply with G4LP guidelines as assessed by a Self-Motivation Questionnaire at screening (see Appendix 16.2); 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; 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; Provided voluntary, written, informed consent to participate in the study

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Exclusion Criteria

You are allergic or have had bad reactions to the ingredients in the study medication.

Current participation within the last three months in any weight loss or diet programs

I have type 2 diabetes and am being treated with insulin.

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Treatment Details

Interventions

Release (Dietary Supplement)

Trial OverviewThe study tests the GOLO for Life Plan with Release supplement's effectiveness on weight loss and health markers like body fat percentage over six months. Participants' progress is tracked using DEXA scans and other measurements.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Golo for Life® Plan(G4LP) and Release SupplementExperimental Treatment1 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.