β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults

Not Applicable

• Conditions: Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: HMB-enriched Nutritional Supplements; Behavioral: Caloric Restrition Diet

• Registration Number: NCT04953936
• Lead Sponsor: West China Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-12
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-07-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14
• Study Start: 2021-09-20
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Men and women aged 30-50 years
2. Currently having obesity defined by body mass index (BMI) ≥ 28 kg/m2 (based on measured body weight and height at booking, using validated scales)
3. Having an intention to lost weight via caloric restriction
4. Apparently healthy and able to walk independently
5. Able to eat independently to meet their energy needs
6. Without significant body weight change in the last 6 month (less than 5% change in body weight)
7. Having sedentary habit defined by Sedentary Behavior Research Network
8. Able to collaborate with the research staff.

Exclusion Criteria

1. Having a history of intolerance to enteral nutrition, food (e.g., lactose intolerance), or being allergic to the components of our HMB-enriched nutritional supplements (e.g., soy or corn);
2. Having any implants (e.g., pacemakers);
3. Current use of other nutritional supplements or drugs that may have an impact on the effectiveness of the intervention (e.g., glucocorticoids, antineoplastic drugs, antituberculosis drugs, sedatives, antipsychotics, muscle relaxants, monoamine oxidase inhibitors, antibiotics) within 3 months prior to enrollment;
4. Secondary obesity caused by diseases (e.g., hypothalamic diseases and hypercortisolism) or drugs (e.g. glucocorticoids, insulin, tricyclic antidepressants);
5. Clinically visible edema;
6. Trauma, surgery, hospitalization, fall, or fracture within 6 months prior to enrollment;
7. Pregnancy, having pregnancy plans, or lactation;
8. Individuals who are participating in other clinical trials; any acute illness (e.g., acute infection, myocardial infarction, arrhythmia, myocarditis, appendicitis, etc.);
9. Swallowing disorders; abnormal thyroid function (including hyperthyroidism and hypothyroidism);
10. Having a history of diabetes, respiratory diseases, cardiovascular diseases, uncontrolled hypertension, kidney diseases, digestive system diseases, renal insufficiency, mental illness, neurological diseases, hematologic diseases, liver diseases (except for fatty liver), chronic infection (e.g., tuberculosis), immune system diseases, joint disorders, any type of tumor;
11. Alcohol consumption over two standard alcoholic beverages (20 g of alcohol/day);
12. Difficulty to comply with the study protocol;
13. Other conditions that indicate the individuals are inappropriate for participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The participants will receive a placebo (maltodextrin 65 g once daily) with the same package as the intervention.
Placebo	Caloric Restrition Diet	The participants will receive a placebo (maltodextrin 65 g once daily) with the same package as the intervention.
HMB	HMB-enriched Nutritional Supplements	The participants will receive oral HMB-enriched nutritional supplements (65 g once daily)
HMB	Caloric Restrition Diet	The participants will receive oral HMB-enriched nutritional supplements (65 g once daily)

Primary Outcome Measures

Name	Time	Method
The mean change in whole-body skeletal muscle mass (SMM)	12 weeks	The whole-body skeletal muscle mass (SMM)

Secondary Outcome Measures

Name	Time	Method
The mean change in body weight (BW)	12 weeks	These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in hip circumference	6 and 12 weeks	Hip circumference was measured as the maximum circumference over the buttocks
The mean change in physical activity	From the beginning to weeks 3, 6, 9, and 12.	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.
The mean change in HOMA-IR	12 weeks	It will be tested using standard method.
The mean change in basal metabolic rate (BMR)	12 weeks	These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in phase angle (PA)	12 weeks	These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in waist circumference	6 and 12 weeks	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.
The mean change in the score of the sit-to-stand test	6 and 12 weeks	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.
The mean change in albumin	12 weeks	It will be tested using standard method.
The mean change in energy intake	From the beginning to weeks 3, 6, 9, and 12	It will be measured for all participants using the self-reported Food Frequency Questionnaire (FFQ)
The mean change in lipid profiles	12 weeks	It will be tested using standard method.
The mean change in fasting glucose	12 weeks	It will be tested using standard method.
The mean change in fasting insulin	12 weeks	It will be tested using standard method.
The mean change in trunk body fat mass (TBFM)	12 weeks	These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in total appendicular body fat mass (ABFM)	12 weeks	These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in total body fat mass (BFM)	12 weeks	These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in trunk skeletal muscle mass (TSMM)	12 weeks	These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in handgrip strength (HGS)	6 and 12 weeks	A trained nurse will measure HGS using a digital handheld dynamometer (EH101; Xiangshan Inc, Guangdong, China) to the nearest 0.1 kg .
The mean change in appendicular skeletal muscle mass (ASMM)	12 weeks	These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).

Trial Locations

Locations (1)

West China Hospital，Sichuan University; 🇨🇳 Chengdu, Sichuan, China