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

Part of paid clinical trials in Lehi, Utah.

Sponsor
Nature's Sunshine Products, Inc.
Study ID
NCT07447843
Status
Not Yet Recruiting

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Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Redefine — DIETARY_SUPPLEMENT
    Redefine, a nutritional formulation composed of beta-hydroxy-beta-methylbutyrate (HMB), an Akkermansia-derived postbiotic, and herbal extracts.
  • Placebo — DIETARY_SUPPLEMENT
    Placebo is formulated from a blend of flavors, colorants, and excipients that closely resemble Redefine

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Redefine for 60 days
    Participants consume Redefine daily for 60 days
  • Placebo Comparator: Placebo for 60 days
    Participants consume Placebo daily for 60 days
  • Experimental: Redefine for 90 days
    Participants consume Redefine daily for 90 days
  • Placebo Comparator: Placebo for 90 days
    Participants consume Placebo daily for 90 days

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Breakthrough MedicalLehiUtah84048
Rustin Gibbs
[email protected]
801-921-6340
Cherlyn Gibbs
[email protected]
801-921-6340

Find similar trials in Lehi, UT

By research site
Breakthrough Medical· Lehi, UT

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