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

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.

Description

Eligibility

Age range

35–65 years

Sex

All

Healthy volunteers

No

Interventions

• Dietary Supplement
  Redefine

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

• Dietary Supplement
  Placebo

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

Location