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...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e055420.full |
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| author | Ming Yang Xiaofan Jing Yuxiang Liang Renjie Wang Hongbo Fu Jiaojiao Jiang |
| author_facet | Ming Yang Xiaofan Jing Yuxiang Liang Renjie Wang Hongbo Fu Jiaojiao Jiang |
| author_sort | Ming Yang |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a3671a2aa9114b21a9c192073c5a6261 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a3671a2aa9114b21a9c192073c5a62612025-01-27T17:50:10ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-055420β-hydroxy-β-methylbutyrate-enriched nutritional supplements for obese adults during weight loss: study protocol of a randomised, double-blind, placebo-controlled clinical trialMing Yang0Xiaofan Jing1Yuxiang Liang2Renjie Wang3Hongbo Fu4Jiaojiao Jiang5School of Pharmacy, North Sichuan Medical College, Nanchong, Sichuan, ChinaDepartment of Clinical Nutrition, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaRehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaRehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaCenter of Gerontology and Geriatrics, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaRehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaIntroduction 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.https://bmjopen.bmj.com/content/12/6/e055420.full |
| spellingShingle | Ming Yang Xiaofan Jing Yuxiang Liang Renjie Wang Hongbo Fu Jiaojiao Jiang β-hydroxy-β-methylbutyrate-enriched nutritional supplements for obese adults during weight loss: study protocol of a randomised, double-blind, placebo-controlled clinical trial BMJ Open |
| title | β-hydroxy-β-methylbutyrate-enriched nutritional supplements for obese adults during weight loss: study protocol of a randomised, double-blind, placebo-controlled clinical trial |
| title_full | β-hydroxy-β-methylbutyrate-enriched nutritional supplements for obese adults during weight loss: study protocol of a randomised, double-blind, placebo-controlled clinical trial |
| title_fullStr | β-hydroxy-β-methylbutyrate-enriched nutritional supplements for obese adults during weight loss: study protocol of a randomised, double-blind, placebo-controlled clinical trial |
| title_full_unstemmed | β-hydroxy-β-methylbutyrate-enriched nutritional supplements for obese adults during weight loss: study protocol of a randomised, double-blind, placebo-controlled clinical trial |
| title_short | β-hydroxy-β-methylbutyrate-enriched nutritional supplements for obese adults during weight loss: study protocol of a randomised, double-blind, placebo-controlled clinical trial |
| title_sort | β hydroxy β methylbutyrate enriched nutritional supplements for obese adults during weight loss study protocol of a randomised double blind placebo controlled clinical trial |
| url | https://bmjopen.bmj.com/content/12/6/e055420.full |
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