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

NCT ID: NCT04953936

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2021-12-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HMB

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

Group Type: EXPERIMENTAL

HMB-enriched Nutritional Supplements

Intervention Type: 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.

Caloric Restrition Diet

Intervention Type: BEHAVIORAL

Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo (maltodextrin 65 g once daily) with the same package as the intervention.

Caloric Restrition Diet

Intervention Type: BEHAVIORAL

Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies

Interventions

HMB-enriched Nutritional Supplements

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo (maltodextrin 65 g once daily) with the same package as the intervention.

Intervention Type: DIETARY_SUPPLEMENT

Caloric Restrition Diet

Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yuxiang Liang

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Yang

Role: STUDY_CHAIR

West China Hospital

Jiaojiao Jiang

Role: STUDY_DIRECTOR

West China Hospital

Locations

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Countries

China

Central Contacts

Yuxaing Liang

Role: CONTACT

yx45liang@sina.com

0086-13982250862

References

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.

Reference Type: DERIVED

PMID: 35738656 (View on PubMed)

Other Identifiers

2021（202）

Identifier Type: -

Identifier Source: org_study_id