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

Sichuan University

Status: Unknown

Conditions: Obesity

Treatments: Behavioral: Caloric Restrition Diet; Dietary Supplement: Placebo; Dietary Supplement: HMB-enriched Nutritional Supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT04953936

2021（202）

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

HMB

Experimental group

Description:

The participants will receive oral HMB-enriched nutritional supplements (65 g once daily)

Treatment:

Dietary Supplement: HMB-enriched Nutritional Supplements

Behavioral: Caloric Restrition Diet

Placebo

Placebo Comparator group

Description:

The participants will receive a placebo (maltodextrin 65 g once daily) with the same package as the intervention.

Treatment:

Dietary Supplement: Placebo

Behavioral: Caloric Restrition Diet