Back to resultsβ-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HMB-enriched Nutritional Supplements
Placebo
Caloric Restrition Diet
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- West China Hospital，Sichuan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HMB
Placebo
Arm Description
The participants will receive oral HMB-enriched nutritional supplements (65 g once daily)
The participants will receive a placebo (maltodextrin 65 g once daily) with the same package as the intervention.
Outcomes
Primary Outcome Measures
The mean change in whole-body skeletal muscle mass (SMM)
The whole-body skeletal muscle mass (SMM)
Secondary Outcome Measures
The mean change in appendicular skeletal muscle mass (ASMM)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in trunk skeletal muscle mass (TSMM)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in total body fat mass (BFM)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in total appendicular body fat mass (ABFM)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in trunk body fat mass (TBFM)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in basal metabolic rate (BMR)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in phase angle (PA)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in body weight (BW)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
The mean change in handgrip strength (HGS)
A trained nurse will measure HGS using a digital handheld dynamometer (EH101; Xiangshan Inc, Guangdong, China) to the nearest 0.1 kg .
The mean change in waist circumference
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.
The mean change in hip circumference
Hip circumference was measured as the maximum circumference over the buttocks
The mean change in physical activity
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.
The mean change in the score of the sit-to-stand test
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.
The mean change in energy intake
It will be measured for all participants using the self-reported Food Frequency Questionnaire (FFQ)
The mean change in lipid profiles
It will be tested using standard method.
The mean change in fasting glucose
It will be tested using standard method.
The mean change in fasting insulin
It will be tested using standard method.
The mean change in HOMA-IR
It will be tested using standard method.
The mean change in albumin
It will be tested using standard method.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04953936
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2021 (Anticipated)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HMB
Arm Type
Experimental
Arm Description
The participants will receive oral HMB-enriched nutritional supplements (65 g once daily)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The participants will receive a placebo (maltodextrin 65 g once daily) with the same package as the intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
HMB-enriched Nutritional Supplements
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Placebo (maltodextrin 65 g once daily) with the same package as the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Caloric Restrition Diet
Intervention Description
Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies
Primary Outcome Measure Information:
Title
The mean change in whole-body skeletal muscle mass (SMM)
Description
The whole-body skeletal muscle mass (SMM)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The mean change in appendicular skeletal muscle mass (ASMM)
Description
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Time Frame
12 weeks
Title
The mean change in trunk skeletal muscle mass (TSMM)
Description
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Time Frame
12 weeks
Title
The mean change in total body fat mass (BFM)
Description
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Time Frame
12 weeks
Title
The mean change in total appendicular body fat mass (ABFM)
Description
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Time Frame
12 weeks
Title
The mean change in trunk body fat mass (TBFM)
Description
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Time Frame
12 weeks
Title
The mean change in basal metabolic rate (BMR)
Description
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Time Frame
12 weeks
Title
The mean change in phase angle (PA)
Description
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Time Frame
12 weeks
Title
The mean change in body weight (BW)
Description
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Time Frame
12 weeks
Title
The mean change in handgrip strength (HGS)
Description
A trained nurse will measure HGS using a digital handheld dynamometer (EH101; Xiangshan Inc, Guangdong, China) to the nearest 0.1 kg .
Time Frame
6 and 12 weeks
Title
The mean change in waist circumference
Description
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.
Time Frame
6 and 12 weeks
Title
The mean change in hip circumference
Description
Hip circumference was measured as the maximum circumference over the buttocks
Time Frame
6 and 12 weeks
Title
The mean change in physical activity
Description
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.
Time Frame
From the beginning to weeks 3, 6, 9, and 12.
Title
The mean change in the score of the sit-to-stand test
Description
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.
Time Frame
6 and 12 weeks
Title
The mean change in energy intake
Description
It will be measured for all participants using the self-reported Food Frequency Questionnaire (FFQ)
Time Frame
From the beginning to weeks 3, 6, 9, and 12
Title
The mean change in lipid profiles
Description
It will be tested using standard method.
Time Frame
12 weeks
Title
The mean change in fasting glucose
Description
It will be tested using standard method.
Time Frame
12 weeks
Title
The mean change in fasting insulin
Description
It will be tested using standard method.
Time Frame
12 weeks
Title
The mean change in HOMA-IR
Description
It will be tested using standard method.
Time Frame
12 weeks
Title
The mean change in albumin
Description
It will be tested using standard method.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuxaing Liang
Phone
0086-13982250862
Email
yx45liang@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Yang
Organizational Affiliation
West China Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jiaojiao Jiang
Organizational Affiliation
West China Hospital
Official's Role
Study Director
Facility Information:
Facility Name
West China Hospital，Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610064
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35738656
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.
Results Reference
derived
Learn more about this trial
β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults
We'll reach out to this number within 24 hrs