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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04953936
Recruitment Status : Not yet recruiting
First Posted : July 8, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Yuxiang Liang, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: HMB-enriched Nutritional Supplements Dietary Supplement: Placebo Behavioral: Caloric Restrition Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults During Weight Loss: a Randomized Double-blind Placebo-controlled Clinical Trial
Estimated Study Start Date : September 20, 2021
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HMB
The participants will receive oral HMB-enriched nutritional supplements (65 g once daily)
Dietary Supplement: 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.

Behavioral: Caloric Restrition Diet
Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies

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

Behavioral: Caloric Restrition Diet
Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies




Primary Outcome Measures :
  1. The mean change in whole-body skeletal muscle mass (SMM) [ Time Frame: 12 weeks ]
    The whole-body skeletal muscle mass (SMM)


Secondary Outcome Measures :
  1. The mean change in appendicular skeletal muscle mass (ASMM) [ Time Frame: 12 weeks ]
    These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).

  2. The mean change in trunk skeletal muscle mass (TSMM) [ Time Frame: 12 weeks ]
    These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).

  3. The mean change in total body fat mass (BFM) [ Time Frame: 12 weeks ]
    These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).

  4. The mean change in total appendicular body fat mass (ABFM) [ Time Frame: 12 weeks ]
    These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).

  5. The mean change in trunk body fat mass (TBFM) [ Time Frame: 12 weeks ]
    These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).

  6. The mean change in basal metabolic rate (BMR) [ Time Frame: 12 weeks ]
    These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).

  7. The mean change in phase angle (PA) [ Time Frame: 12 weeks ]
    These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).

  8. The mean change in body weight (BW) [ Time Frame: 12 weeks ]
    These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).

  9. The mean change in handgrip strength (HGS) [ Time Frame: 6 and 12 weeks ]
    A trained nurse will measure HGS using a digital handheld dynamometer (EH101; Xiangshan Inc, Guangdong, China) to the nearest 0.1 kg .

  10. The mean change in waist circumference [ Time Frame: 6 and 12 weeks ]
    A trained nurse will measure waist circumference using a tape at the level midway between the lower rib margin and the iliac crest with the participant breathing out gently.

  11. The mean change in hip circumference [ Time Frame: 6 and 12 weeks ]
    Hip circumference was measured as the maximum circumference over the buttocks

  12. The mean change in physical activity [ Time Frame: From the beginning to weeks 3, 6, 9, and 12. ]
    It will be measured using self-reported International Physical Activity Questionnaire Short Form (IPAQ-SF).The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health related physical activity.

  13. The mean change in the score of the sit-to-stand test [ Time Frame: 6 and 12 weeks ]
    A trained nurse will perform the 30-second sit-to-stand test ,which is a classic test for measuring the performance of lower extremity muscles.

  14. The mean change in energy intake [ Time Frame: From the beginning to weeks 3, 6, 9, and 12 ]
    It will be measured for all participants using the self-reported Food Frequency Questionnaire (FFQ)

  15. The mean change in lipid profiles [ Time Frame: 12 weeks ]
    It will be tested using standard method.

  16. The mean change in fasting glucose [ Time Frame: 12 weeks ]
    It will be tested using standard method.

  17. The mean change in fasting insulin [ Time Frame: 12 weeks ]
    It will be tested using standard method.

  18. The mean change in HOMA-IR [ Time Frame: 12 weeks ]
    It will be tested using standard method.

  19. The mean change in albumin [ Time Frame: 12 weeks ]
    It will be tested using standard method.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04953936


Contacts
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Contact: Yuxaing Liang 0086-13982250862 yx45liang@sina.com

Locations
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China, Sichuan
West China Hospital,Sichuan University
Chengdu, Sichuan, China, 610064
Sponsors and Collaborators
West China Hospital
Investigators
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Study Chair: Ming Yang West China Hospital
Study Director: Jiaojiao Jiang West China Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yuxiang Liang, Physiotherapist, West China Hospital
ClinicalTrials.gov Identifier: NCT04953936    
Other Study ID Numbers: 2021(202)
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight