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

NCT04953936 | Unknown

• 1 other identifier: 2021（202）
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The mean change in whole-body skeletal muscle mass (SMM)

  The whole-body skeletal muscle mass (SMM)

  12 weeks

Secondary Outcomes (19)

• The mean change in appendicular skeletal muscle mass (ASMM)

  12 weeks

• The mean change in trunk skeletal muscle mass (TSMM)

  12 weeks

• The mean change in total body fat mass (BFM)

  12 weeks

• The mean change in total appendicular body fat mass (ABFM)

  12 weeks

• The mean change in trunk body fat mass (TBFM)

  12 weeks

Study Arms (2)

HMB

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo; Behavioral: Caloric Restrition Diet

Interventions

HMB-enriched Nutritional Supplements 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.

HMB

Placebo DIETARY_SUPPLEMENT

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

Placebo

Caloric Restrition Diet BEHAVIORAL

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

HMB; Placebo

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital，Sichuan University

Chengdu, Sichuan, 610064, China

Location

Related Publications (1)

• 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.

  PMID: 35738656 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ming Yang

  West China Hospital

  STUDY CHAIR

• Jiaojiao Jiang

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Yuxaing Liang

CONTACT

0086-13982250862; yx45liang@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: July 8, 2021
• Study Start: September 20, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)