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Study of Redefine for Muscle Maintenance During Weight Loss

This study is looking at a nutritional formula called Redefine, which contains HMB, an Akkermansia-derived postbiotic, and herbal extracts. It's designed to help adults maintain muscle while losing weight, especially when using a medication like semaglutide (a GLP-1 receptor agonist) for weight loss. The study wants to see if Redefine is safe and well-tolerated when used alongside a diet that restricts calories. You might be able to join if you are between 35 and 65 years old, have a BMI (Body Mass Index) between 25.0 and 34, and are currently taking 1 mg of semaglutide weekly for weight loss. The main goal is to track any side effects from Redefine over 90 days. The study is currently unclear on its recruitment status and plans to enroll 80 participants.

Study design
This is an interventional study, meaning participants will receive either Redefine or a placebo (an inactive substance that looks like Redefine). It aims to enroll 80 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for safety is measured at 90 days after starting supplementation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07447843

Safety and Tolerability of a Nutritional Formula Designed to Aid in Maintenance of Muscle During Periods of Caloric Restriction in Adults

Not Yet Recruiting
NAAges 35–65InterventionalBasic science
Nature's Sunshine Products, Inc.
~80 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:RedefinePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with supplementation-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).
Measured over 90 days

Conditions

Obesity & Overweight

Explore related trials

ObesityOverweight

Where it's being run

1 sites across 1 states
Utah1

Study leadership

  • Joseph Lamb, MD · PRINCIPAL_INVESTIGATOR · Natures Sunshine

Who to contact

Bhargavi Manda, PhD
[email protected]
801-341-7984
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Has been receiving a GLP-1 receptor agonist (semaglutide) treatment for weight loss, and is titrated to start receiving a weekly dose of 1 mg semaglutide (Inclusive)
Body Mass Index (BMI): At study enrollment (participants that have achieved 1 mg titration), 25.0-34.9 (kg/m2) while receiving a GLP-1 receptor agonist (semaglutide) (inclusive)
Willing to give written informed consent to participate in the Study

Exclusion

A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or oncological/hematologic disease.
Allergies related to ingredients in Study products
Known infection with HIV, TB or Hepatitis B or C.
POCBP: Not using effective contraception.
Discontinuation of semaglutide treatment.
Discontinuation of semaglutide treatment may be necessary in some cases. However, during the titration phase, GLP-1-related symptoms often do not require treatment discontinuation or reinitiation.
Diabetes medications
Currently taking any nutritional supplements judged by the study coordinator to negate or camouflage the effects of the Study Products. See below for a brief list of explicitly allowed supplements.
Explicitly allowed supplements: Fish Oil, Multivitamin, Magnesium, Vitamin D, Vitamin C
Use of Narcotics during the last 30 days
Use of Anticoagulants during last 30 days
Use of Corticosteroids during the last 30 days
Use of controlled substances on a recreational basis during the last 30 days.
Consumption of more than 1 alcoholic beverage per day (One beverage is a 5-ounce glass of wine, 12 ounces of beer, or one ounce of hard liquor)
Inability to comply with Study and/or follow-up visits.
Any concurrent condition (including clinically significant abnormalities in medical history, physical examination, or laboratory evaluations) which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance.
Any sound medical, psychiatric and/or social reason which, in the opinion of the PI, would preclude safe participation in this Study or interfere with compliance.

What this trial measures

  • Number of participants with supplementation-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).90 days

    Data collection from weekly surveys and at individual study visits (Baseline, Day-60 and Day-90) will be used to assess participants for supplementation program-related adverse events. Subjects with ongoing AEs may be followed until resolution at the discretion of the PI.