Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07447843

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age35 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight

Full registry criteria

Inclusion Criteria: * 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 Criteria: 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 Other Exclusionary Criteria: * 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.

Treatments and study arms

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

Primary outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Breakthrough Medical🇺🇸 Lehi, Utah, United States

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Rustin GibbsContact

Email · Call 801-921-6340

Cherlyn GibbsContact

Email · Call 801-921-6340