NCT07447843Not yet recruiting
Safety and Tolerability of a Nutritional Formula Designed to Aid in Maintenance of Muscle During Periods of Caloric Restriction in Adults
An Adaptive, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Assessing the Safety and Tolerability of Redefine, a Multi-Ingredient Nutritional Formulation Designed to Aid Lean Mass Preservation in Subjects Undergoing Caloric Restriction
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
Muscle loss during caloric restriction is a significant concern for metabolic health and physical function, yet there is limited evidence on interventions that simultaneously target multiple contributing pathways. This study investigates a multi-component formulation targeting these complementary pathways to address critical gaps in strategies for preserving lean mass during energy restriction. The primary goal of this study is to demonstrate the safety and tolerability of the product Redefine when used as an adjunct to a well-established caloric restriction regimen. Caloric restriction is known to result in unintended loss of skeletal muscle mass, which may negatively impact physical function and metabolic health. This study seeks to evaluate whether supplementation with Redefine may help preserve muscle mass and support the maintenance of healthy muscle function during caloric restriction. Secondarily, this study aims to explore whether Redefine supplementation may confer favorable changes in body composition in subjects participating in a caloric restriction regimen. This product consists of HMB, postbiotics and botanicals.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 25 Feb 2026
- Start date
- Apr 2026
- Primary completion date
- Aug 2026
- Lead sponsor
- Nature's Sunshine Products, Inc.
- Diseases
- Obesity
- NCT number
- NCT07447843
What you commit to
- Study type: Interventional
- Planned participants: 80
- From Apr 2026 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medical History and Concurrent Diseases:
- POCBP: Not using effective contraception.
- Medications/Supplements:
- 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.
- Use of Corticosteroids during the last 30 days
- Other Exclusionary Criteria:
Other illness
- 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.
- Diabetes medications
- 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.
Lab values
- Explicitly allowed supplements: Fish Oil, Multivitamin, Magnesium, Vitamin D, Vitamin C
- 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.
Other
- 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.
- Use of Narcotics during the last 30 days
- Use of Anticoagulants during 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.
Who the study is looking for
- 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
Age in the registry: 35 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Breakthrough Medical Coordinator of this site? Confirm its status | Lehi | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.