β-hydroxy-β-methylbutyrate-enriched nutritional supplements for obese adults during weight loss: study protocol of a randomised, double-blind, placebo-controlled clinical trial.

INTRODUCTION

Obesity is a public health challenge worldwide. To maintain a healthy weight, dieting and lifestyle changes are the first-line interventions; however, these interventions are of poor compliance and may cause body composition changes, mainly skeletal muscle wasting (sarcopenia). Dietary supplements for improving body composition while inducing weight loss are therefore needed. β-hydroxy-β-methylbutyrate (HMB) has been proven to be effective for improving muscle mass and muscle strength in athletes, older adults and patients with cancer. We aim to evaluate the effectiveness and safety of HMB-enriched nutritional supplements for improving muscle mass and muscle function in obese adults during calorie restriction.

METHOD AND ANALYSIS

A total of 72 Chinese adults with obesity will be randomised to receive HMB-enriched nutritional supplements (65 g/day) or a placebo for 12 weeks. Participants in both groups will also receive calorie restrictions based on the individualised nutrition guidance of dietitians. Participants and investigators will be blinded to the allocations. The primary outcome will be the mean change in whole-body skeletal muscle mass (measured by bioelectrical impedance analysis). The secondary outcomes will include the mean change of appendicular skeletal muscle mass, body fat mass, basal metabolic rate, phase angle, muscle function and serum biomarkers. The enrolment will commence in December 2021 and will proceed until March 2022.

ETHICS AND DISSEMINATION

This protocol has been approved by the Biomedical Ethics Committee of West China Hospital (2021-771). All potential subjects will be required to sign a written informed consent. The results of this study will be reported in peer-reviewed academic journals and conferences.

TRIAL REGISTRATION NUMBER

NCT04953936.