Clinical trial NCT04953936: β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults
Official title: β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults During Weight Loss: a Randomized Double-blind Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The mean change in whole-body skeletal muscle mass (SMM)
timeFrame: 12 weeks
Secondary outcomes:
measure: The mean change in appendicular skeletal muscle mass (ASMM)
timeFrame: 12 weeks
measure: The mean change in trunk skeletal muscle mass (TSMM)
timeFrame: 12 weeks
measure: The mean change in total body fat mass (BFM)
timeFrame: 12 weeks
measure: The mean change in total appendicular body fat mass (ABFM)
timeFrame: 12 weeks
measure: The mean change in trunk body fat mass (TBFM)
timeFrame: 12 weeks
measure: The mean change in basal metabolic rate (BMR)
timeFrame: 12 weeks
measure: The mean change in phase angle (PA)
timeFrame: 12 weeks
measure: The mean change in body weight (BW)
timeFrame: 12 weeks
measure: The mean change in handgrip strength (HGS)
timeFrame: 6 and 12 weeks
measure: The mean change in waist circumference
timeFrame: 6 and 12 weeks
measure: The mean change in hip circumference
timeFrame: 6 and 12 weeks
measure: The mean change in physical activity
timeFrame: From the beginning to weeks 3, 6, 9, and 12.
measure: The mean change in the score of the sit-to-stand test
timeFrame: 6 and 12 weeks
measure: The mean change in energy intake
timeFrame: From the beginning to weeks 3, 6, 9, and 12
measure: The mean change in lipid profiles
timeFrame: 12 weeks
measure: The mean change in fasting glucose
timeFrame: 12 weeks
measure: The mean change in fasting insulin
timeFrame: 12 weeks
measure: The mean change in HOMA-IR
timeFrame: 12 weeks
measure: The mean change in albumin
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital，Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Ming Yang
role: STUDY_CHAIR
affiliation: West China Hospital
name: Jiaojiao Jiang
role: STUDY_DIRECTOR
References:
citation: 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.