Department of Clinical Nutrition, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
BMJ Open. 2022 Jun 23;12(6):e055420. doi: 10.1136/bmjopen-2021-055420.
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.
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.
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.
NCT04953936.
肥胖是全球范围内的公共健康挑战。为了保持健康的体重，饮食和生活方式的改变是一线干预措施；然而，这些干预措施的依从性较差，可能导致身体成分的变化，主要是骨骼肌减少（肌少症）。因此，需要有改善身体成分同时减轻体重的膳食补充剂。β-羟基-β-甲基丁酸（HMB）已被证明可有效增加运动员、老年人和癌症患者的肌肉质量和肌肉力量。我们旨在评估富含 HMB 的营养补充剂在肥胖成年人热量限制期间改善肌肉质量和肌肉功能的有效性和安全性。
共有 72 名中国肥胖成年人将被随机分配接受富含 HMB 的营养补充剂（65 克/天）或安慰剂治疗 12 周。两组参与者还将根据营养师的个性化营养指导进行热量限制。参与者和研究人员将对分配情况保持盲态。主要结局将是全身骨骼肌质量的平均变化（通过生物电阻抗分析测量）。次要结局包括四肢骨骼肌质量、体脂肪量、基础代谢率、相位角、肌肉功能和血清生物标志物的平均变化。招募工作将于 2021 年 12 月开始，持续到 2022 年 3 月。
本方案已获得华西医院生物医学伦理委员会的批准（2021-771）。所有潜在的受试者都将被要求签署书面知情同意书。本研究的结果将在同行评议的学术期刊和会议上报告。
NCT04953936。
