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

NCT07447843 | Not Yet Recruiting

• 1 other identifier: NSP-CT-024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity & Overweight

Outcome Measures

Primary Outcomes (1)

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

  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.

  90 days

Secondary Outcomes (1)

• Change in body composition with Redefine compared to placebo

  90 days

Other Outcomes (2)

• Changes in Grip Strength with Redefine compared to Placebo

  90 days

• Changes in self-perceived health with Redefine compared to placebo

  90 days

Study Arms (4)

Redefine for 60 days

EXPERIMENTAL

Participants consume Redefine daily for 60 days

Dietary Supplement: Redefine

Placebo for 60 days

PLACEBO COMPARATOR

Participants consume Placebo daily for 60 days

Dietary Supplement: Placebo

Redefine for 90 days

EXPERIMENTAL

Participants consume Redefine daily for 90 days

Dietary Supplement: Redefine

Placebo for 90 days

PLACEBO COMPARATOR

Participants consume Placebo daily for 90 days

Dietary Supplement: Placebo

Interventions

Redefine DIETARY_SUPPLEMENT

Redefine, a nutritional formulation composed of beta-hydroxy-beta-methylbutyrate (HMB), an Akkermansia-derived postbiotic, and herbal extracts.

Redefine for 60 days; Redefine for 90 days

Placebo DIETARY_SUPPLEMENT

Placebo is formulated from a blend of flavors, colorants, and excipients that closely resemble Redefine

Placebo for 60 days; Placebo for 90 days

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Medical History and Concurrent Diseases:
• 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.
• Medications/Supplements:
• 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.

Sponsors & Collaborators

• Nature's Sunshine Products, Inc.: lead

Study Sites (1)

Breakthrough Medical

Lehi, Utah, 84048, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Lamb, MD

  Natures Sunshine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bhargavi Manda, PhD

CONTACT

801-341-7984; bhargavi@natr.com

Wei Gao, PhD

CONTACT

801-341-7903; weig@natr.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Adaptive, Randomized, double-blind, placebo-controlled, four-arm study.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)