Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the effectiveness and safety of HMB-enriched nutritional supplements for improving muscle mass and muscle function in Chinese adults with obesity during the weight loss process using calorie restriction.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMB | Experimental | The participants will receive oral HMB-enriched nutritional supplements (65 g once daily) |
|
| Placebo | Placebo Comparator | The participants will receive a placebo (maltodextrin 65 g once daily) with the same package as the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMB-enriched Nutritional Supplements | Dietary Supplement | The participants will receive oral HMB-enriched nutritional supplements (65 g, once daily), which include soybean isolate protein, flaxseed oil powder, yam powder, whey protein, oligomeric isomaltose powder, cocoa powder, medium-chain fatty acid powder, calcium beta-hydroxy-beta-methylbutyrate, sunflower seed oil powder, L-glutamine, wheat germ powder, membrane isolated casein, wheat oligopeptide, konjac flour, vitamin E, vitamin D, stevioside, edible flavors. |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change in whole-body skeletal muscle mass (SMM) | The whole-body skeletal muscle mass (SMM) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change in appendicular skeletal muscle mass (ASMM) | These data will be measured using InBody 770 (Biospace Co., Seoul, Korea). | 12 weeks |
| The mean change in trunk skeletal muscle mass (TSMM) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuxaing Liang | Contact | 0086-13982250862 | yx45liang@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Ming Yang | West China Hospital | Study Chair |
| Jiaojiao Jiang | West China Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital,Sichuan University | Chengdu | Sichuan | 610064 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35738656 | Derived | Jing X, Liang Y, Wang R, Fu H, Jiang J, Yang M. beta-hydroxy-beta-methylbutyrate-enriched nutritional supplements for obese adults during weight loss: study protocol of a randomised, double-blind, placebo-controlled clinical trial. BMJ Open. 2022 Jun 23;12(6):e055420. doi: 10.1136/bmjopen-2021-055420. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Dietary Supplement | Placebo (maltodextrin 65 g once daily) with the same package as the intervention. |
|
| Caloric Restrition Diet | Behavioral | Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies |
|
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
| 12 weeks |
| The mean change in total body fat mass (BFM) | These data will be measured using InBody 770 (Biospace Co., Seoul, Korea). | 12 weeks |
| The mean change in total appendicular body fat mass (ABFM) | These data will be measured using InBody 770 (Biospace Co., Seoul, Korea). | 12 weeks |
| The mean change in trunk body fat mass (TBFM) | These data will be measured using InBody 770 (Biospace Co., Seoul, Korea). | 12 weeks |
| The mean change in basal metabolic rate (BMR) | These data will be measured using InBody 770 (Biospace Co., Seoul, Korea). | 12 weeks |
| The mean change in phase angle (PA) | These data will be measured using InBody 770 (Biospace Co., Seoul, Korea). | 12 weeks |
| The mean change in body weight (BW) | These data will be measured using InBody 770 (Biospace Co., Seoul, Korea). | 12 weeks |
| The mean change in handgrip strength (HGS) | A trained nurse will measure HGS using a digital handheld dynamometer (EH101; Xiangshan Inc, Guangdong, China) to the nearest 0.1 kg . | 6 and 12 weeks |
| The mean change in waist circumference | A trained nurse will measure waist circumference using a tape at the level midway between the lower rib margin and the iliac crest with the participant breathing out gently. | 6 and 12 weeks |
| The mean change in hip circumference | Hip circumference was measured as the maximum circumference over the buttocks | 6 and 12 weeks |
| The mean change in physical activity | It will be measured using self-reported International Physical Activity Questionnaire Short Form (IPAQ-SF).The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health related physical activity. | From the beginning to weeks 3, 6, 9, and 12. |
| The mean change in the score of the sit-to-stand test | A trained nurse will perform the 30-second sit-to-stand test ,which is a classic test for measuring the performance of lower extremity muscles. | 6 and 12 weeks |
| The mean change in energy intake | It will be measured for all participants using the self-reported Food Frequency Questionnaire (FFQ) | From the beginning to weeks 3, 6, 9, and 12 |
| The mean change in lipid profiles | It will be tested using standard method. | 12 weeks |
| The mean change in fasting glucose | It will be tested using standard method. | 12 weeks |
| The mean change in fasting insulin | It will be tested using standard method. | 12 weeks |
| The mean change in HOMA-IR | It will be tested using standard method. | 12 weeks |
| The mean change in albumin | It will be tested using standard method. | 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |