ObesityNCT04953936
β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults
A study testing HMB-enriched Nutritional Supplements and Caloric Restrition Diet in people with Obesity, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Obesity
- What is being tested?
- HMB-enriched Nutritional Supplements and Caloric Restrition Diet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults During Weight Loss: a Randomized Double-blind Placebo-controlled Clinical Trial
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
- Being tested
- HMB-enriched Nutritional Supplements, Placebo, Caloric Restrition Diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMB-enriched Nutritional SupplementsDietary 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.
PlaceboDietary supplement
Placebo (maltodextrin 65 g once daily) with the same package as the intervention.
Caloric Restrition DietBehavioural
Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies
| Study group | Role | What they receive |
|---|---|---|
| HMB | Experimental | The participants will receive oral HMB-enriched nutritional supplements (65 g once daily) Receives: 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. Receives: Dietary Supplement: Placebo; Behavioral: Caloric Restrition Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in whole-body skeletal muscle mass (SMM)
The whole-body skeletal muscle mass (SMM)
Measured: 12 weeks
Secondary outcomes (19)
The mean change in appendicular skeletal muscle mass (ASMM)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Measured: 12 weeks
The mean change in trunk skeletal muscle mass (TSMM)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Measured: 12 weeks
The mean change in total body fat mass (BFM)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Measured: 12 weeks
The mean change in total appendicular body fat mass (ABFM)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Measured: 12 weeks
The mean change in trunk body fat mass (TBFM)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Measured: 12 weeks
The mean change in basal metabolic rate (BMR)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Measured: 12 weeks
The mean change in phase angle (PA)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Measured: 12 weeks
The mean change in body weight (BW)
These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
Measured: 12 weeks
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 .
Measured: 6 and 12 weeks
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.
Measured: 6 and 12 weeks
The mean change in hip circumference
Hip circumference was measured as the maximum circumference over the buttocks
Measured: 6 and 12 weeks
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.
Measured: From the beginning to weeks 3, 6, 9, and 12.
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.
Measured: 6 and 12 weeks
The mean change in energy intake
It will be measured for all participants using the self-reported Food Frequency Questionnaire (FFQ)
Measured: From the beginning to weeks 3, 6, 9, and 12
The mean change in lipid profiles
It will be tested using standard method.
Measured: 12 weeks
The mean change in fasting glucose
It will be tested using standard method.
Measured: 12 weeks
The mean change in fasting insulin
It will be tested using standard method.
Measured: 12 weeks
The mean change in HOMA-IR
It will be tested using standard method.
Measured: 12 weeks
The mean change in albumin
It will be tested using standard method.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start20 Sep 2021 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuxiang Liang, West China Hospital
- Investigators
- Ming Yang, Study chair, West China HospitalJiaojiao Jiang, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953936
- Sponsor's protocol ID
- 2021（202）
- Status last verified
- Sep 2021
- First submitted
- 12 Jun 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang J, Liang Y, Wang R, Jiang W, Jing X, Yang M. Calcium Beta-Hydroxy-Beta-Methylbutyrate-Enriched Nutritional Supplementation During Dietary Weight Loss in Adults With Obesity: A Randomized Controlled Trial. J Cachexia Sarcopenia Muscle. 2026 Aug;17(4):e70343. doi: 10.1002/jcsm.70343.
PubMed 42444106Jing 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.
PubMed 35738656
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults During Weight Loss: a Randomized Double-blind Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04953936
- Acronym / sponsor ID
- 2021（202）
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 20 Sep 2021 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMB | Experimental | Dietary Supplement: HMB-enriched Nutritional Supplements, Behavioral: Caloric Restrition DietThe participants will receive oral HMB-enriched nutritional supplements (65 g once daily) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Behavioral: Caloric Restrition DietThe participants will receive a placebo (maltodextrin 65 g once daily) with the same package as the intervention. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMB-enriched Nutritional SupplementsThe 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. | Dietary supplement | HMB |
| PlaceboPlacebo (maltodextrin 65 g once daily) with the same package as the intervention. | Dietary supplement | Placebo |
| Caloric Restrition DietCaloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies | Behavioural | HMB, Placebo |
Primary outcome
The mean change in whole-body skeletal muscle mass (SMM)
Time frame: 12 weeks
The whole-body skeletal muscle mass (SMM)
19 secondary outcomes
The mean change in appendicular skeletal muscle mass (ASMM)
Time frame: 12 weeks
The mean change in trunk skeletal muscle mass (TSMM)
Time frame: 12 weeks
The mean change in total body fat mass (BFM)
Time frame: 12 weeks
The mean change in total appendicular body fat mass (ABFM)
Time frame: 12 weeks
The mean change in trunk body fat mass (TBFM)
Time frame: 12 weeks
The mean change in basal metabolic rate (BMR)
Time frame: 12 weeks
The mean change in phase angle (PA)
Time frame: 12 weeks
The mean change in body weight (BW)
Time frame: 12 weeks
The mean change in handgrip strength (HGS)
Time frame: 6 and 12 weeks
The mean change in waist circumference
Time frame: 6 and 12 weeks
The mean change in hip circumference
Time frame: 6 and 12 weeks
The mean change in physical activity
Time frame: From the beginning to weeks 3, 6, 9, and 12.
The mean change in the score of the sit-to-stand test
Time frame: 6 and 12 weeks
The mean change in energy intake
Time frame: From the beginning to weeks 3, 6, 9, and 12
The mean change in lipid profiles
Time frame: 12 weeks
The mean change in fasting glucose
Time frame: 12 weeks
The mean change in fasting insulin
Time frame: 12 weeks
The mean change in HOMA-IR
Time frame: 12 weeks
The mean change in albumin
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Derived from this study: PubMed 42444106Jiang J, Liang Y, Wang R, Jiang W, Jing X, Yang M. Calcium Beta-Hydroxy-Beta-Methylbutyrate-Enriched Nutritional Supplementation During Dietary Weight Loss in Adults With Obesity: A Randomized Controlled Trial. J Cachexia Sarcopenia Muscle. 2026 Aug;17(4):e70343. doi: 10.1002/jcsm.70343.
- Derived from this study: PubMed 35738656Jing 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Yang study chair
West China Hospital
Jiaojiao Jiang study director
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMB-enriched Nutritional Supplements and Caloric Restrition Diet in people with Obesity, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuxaing Liang (0086-13982250862, yx45liang@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in whole-body skeletal muscle mass (SMM) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04953936, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.