Handgrip StrengthNCT07171593
High-protein Oral Nutrition With HMB for Active CD Patients With Sarcopenia
A study testing HMB in people with Handgrip Strength, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
The efficacy of B-hydroxy-β-methybutyrate in sarcopenia Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Handgrip Strength
- What is being tested?
- HMB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with active Crohn's disease (CD) who visited the Sixth Affiliated Hospital of Sun Yat-sen University between July 2023 and December 2024;
- Aged 18-50 years;
- Complicated with sarcopenia;
- Willing and able to tolerate oral exclusive enteral nutrition (EEN) therapy;
- Signed informed consent and able to comply with the study procedures;
- Colonic or ileocolonic type CD (SES-CD ≥6; if only terminal ileum is involved, SES-CD ≥4).
Who cannot join
- Short bowel syndrome;
- High-output jejunal fistula;
- Severe stress or shock status;
- Complete mechanical intestinal obstruction, acute gastrointestinal bleeding, or severe intra-abdominal infection;
- Severe hepatic, renal, or cardiac diseases, or malignant tumors;
- History of allergy or contraindication to Ensure or HMB;
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- Persistent severe vomiting or intractable diarrhea;
- Congenital disorders of sugar or amino acid metabolism;
- Underwent CD-related intestinal surgery or received biologic therapy within the past month, or received immunosuppressive/antibiotic therapy related to CD within 2 weeks prior to enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sixth Hospital Affiliated to Sun Yat-sen University
Guangzhou, Guangdong, 570000
About this study
Official title: Efficacy of High-protein Oral Enteral Nutrition Supplement Supplemented With HMB in Active Crohn's Disease With Sarcopenia: a Prospective, Randomized, Controlled Study
The efficacy of B-hydroxy-β-methybutyrate in sarcopenia
- Conditions
- Handgrip Strength
- Being tested
- HMB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMBDietary supplement
EEN+HMB
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | EEN |
| Experiment | Experimental | EEN+HMB Receives: Dietary Supplement: HMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength improvement
Grip strength was measured using an electronic dynamometer. Participants sat in an armchair with the upper arm in the adducted neutral position, the elbow flexed at 90°, and the forearm and wrist relaxed naturally. The test hand held the dynamometer and was instructed to squeeze with maximal force smoothly until reaching the peak value, without any twisting or jerking movements of the forearm or hand. After completing the measurement, the other hand was tested using the same method. Each trial was performed three times per hand with a one-minute interval between trials. The maximum value among the six trials was recorded as the final result.
Measured: Week 4; Week 8
Secondary outcomes (5)
Improvement of muscle mass
Appendicular skeletal muscle mass (ASM) was assessed in this study using a body composition analyzer. ASM was defined as the sum of muscle mass in the arms and legs. During the measurement, patients were required to fast, empty their bowels and bladder, wear light clothing, and undergo the test before exercise, bathing, or showering. Female patients were instructed to avoid measurements during menstruation.
Measured: Week 4; Week 8
Clinical response
A decrease in the Crohn's Disease Activity Index (CDAI) by ≥70 points or a CDAI <150.
Measured: Week 4; Week 8
Clinical remission
CDAI <150.
Measured: Week 4; Week 8
Mucosal healing
No visible ulcers on endoscopy.
Measured: Week 4; Week 8
Clinical relapse
CDAI ≥250 at any visit, or CDAI between 150-250 at two consecutive visits one week apart, with an increase of at least 70 points, accompanied by either CRP >5 mg/L or fecal calprotectin >250 μg/g.
Measured: Week 4; Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start4 Mar 2024
- Primary completion22 May 2024
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Handgrip StrengthStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Kang, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Kang Chao, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171593
- Sponsor's protocol ID
- 2023-077
- Status last verified
- Sep 2025
- First submitted
- 10 Apr 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-protein Oral Enteral Nutrition Supplement Supplemented With HMB in Active Crohn's Disease With Sarcopenia: a Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07171593
- Acronym / sponsor ID
- 2023-077
- Conditions
- Handgrip Strength
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Sep 2025 (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 efficacy of B-hydroxy-β-methybutyrate in sarcopenia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –EEN |
| Experiment | Experimental | Dietary Supplement: HMBEEN+HMB |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with active Crohn's disease (CD) who visited the Sixth Affiliated Hospital of Sun Yat-sen University between July 2023 and December 2024;
- Aged 18-50 years;
- Complicated with sarcopenia;
- Willing and able to tolerate oral exclusive enteral nutrition (EEN) therapy;
- Signed informed consent and able to comply with the study procedures;
Key exclusion criteria (9 listed)
- Short bowel syndrome;
- High-output jejunal fistula;
- Severe stress or shock status;
- Complete mechanical intestinal obstruction, acute gastrointestinal bleeding, or severe intra-abdominal infection;
- Severe hepatic, renal, or cardiac diseases, or malignant tumors;
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 |
|---|---|---|
| HMBEEN+HMB | Dietary supplement | Experiment |
Primary outcome
muscle strength improvement
Time frame: Week 4; Week 8
Grip strength was measured using an electronic dynamometer. Participants sat in an armchair with the upper arm in the adducted neutral position, the elbow flexed at 90°, and the forearm and wrist relaxed naturally. The test hand held the dynamometer and was instructed to squeeze with maximal force smoothly until reaching the peak value, without any twisting or jerking movements of the forearm or hand. After completing the measurement, the other hand was tested using the same method. Each trial was performed three times per hand with a one-minute interval between trials. The maximum value among the six trials was recorded as the final result.
5 secondary outcomes
Improvement of muscle mass
Time frame: Week 4; Week 8
Clinical response
Time frame: Week 4; Week 8
Clinical remission
Time frame: Week 4; Week 8
Mucosal healing
Time frame: Week 4; Week 8
Clinical relapse
Time frame: Week 4; Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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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.
Kang Chao principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
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 in people with Handgrip Strength, run by Sixth Affiliated Hospital, Sun Yat-sen University 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 6 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 12 Sep 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength improvement (time frame: Week 4; Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2025.