NCT04953936UnknownNot Applicable
β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults During Weight Loss: a Randomized Double-blind Placebo-controlled Clinical Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- West China Hospital
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- The mean change in whole-body skeletal muscle mass (SMM)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women aged 30-50 years
- •Currently having obesity defined by body mass index (BMI) ≥ 28 kg/m2 (based on measured body weight and height at booking, using validated scales)
- •Having an intention to lost weight via caloric restriction
- •Apparently healthy and able to walk independently
- •Able to eat independently to meet their energy needs
- •Without significant body weight change in the last 6 month (less than 5% change in body weight)
- •Having sedentary habit defined by Sedentary Behavior Research Network
- •Able to collaborate with the research staff.
Exclusion Criteria
- •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);
- •Having any implants (e.g., pacemakers);
- •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;
- •Secondary obesity caused by diseases (e.g., hypothalamic diseases and hypercortisolism) or drugs (e.g. glucocorticoids, insulin, tricyclic antidepressants);
- •Clinically visible edema;
- •Trauma, surgery, hospitalization, fall, or fracture within 6 months prior to enrollment;
- •Pregnancy, having pregnancy plans, or lactation;
- •Individuals who are participating in other clinical trials; any acute illness (e.g., acute infection, myocardial infarction, arrhythmia, myocarditis, appendicitis, etc.);
- •Swallowing disorders; abnormal thyroid function (including hyperthyroidism and hypothyroidism);
- •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;
- •Alcohol consumption over two standard alcoholic beverages (20 g of alcohol/day);
- •Difficulty to comply with the study protocol;
- •Other conditions that indicate the individuals are inappropriate for participation in this study.
Outcomes
Primary Outcomes
The mean change in whole-body skeletal muscle mass (SMM)
Time Frame: 12 weeks
The whole-body skeletal muscle mass (SMM)
Secondary Outcomes
- The mean change in total appendicular body fat mass (ABFM)(12 weeks)
- The mean change in total body fat mass (BFM)(12 weeks)
- The mean change in trunk skeletal muscle mass (TSMM)(12 weeks)
- The mean change in handgrip strength (HGS)(6 and 12 weeks)
- The mean change in appendicular skeletal muscle mass (ASMM)(12 weeks)
- The mean change in trunk body fat mass (TBFM)(12 weeks)
- The mean change in body weight (BW)(12 weeks)
- The mean change in hip circumference(6 and 12 weeks)
- The mean change in physical activity(From the beginning to weeks 3, 6, 9, and 12.)
- The mean change in HOMA-IR(12 weeks)
- The mean change in basal metabolic rate (BMR)(12 weeks)
- The mean change in phase angle (PA)(12 weeks)
- The mean change in waist circumference(6 and 12 weeks)
- The mean change in the score of the sit-to-stand test(6 and 12 weeks)
- The mean change in energy intake(From the beginning to weeks 3, 6, 9, and 12)
- The mean change in lipid profiles(12 weeks)
- The mean change in fasting glucose(12 weeks)
- The mean change in fasting insulin(12 weeks)
- The mean change in albumin(12 weeks)
Investigators
Yuxiang Liang
Physiotherapist
West China Hospital
Study Sites (1)
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