Clinical Trials in China / NCT07171593
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High-protein Oral Nutrition With HMB for Active CD Patients With Sarcopenia
NCT07171593 · tracked via the Priya Life Science China tracker
Condition(s) studied
Handgrip Strength
Investigational drug(s) / intervention(s)
HMB
HMB: EEN+HMB
Study summary
The efficacy of B-hydroxy-β-methybutyrate in sarcopenia
Eligibility
Inclusion Criteria:
1. Patients with active Crohn's disease (CD) who visited the Sixth Affiliated Hospital of Sun Yat-sen University between July 2023 and December 2024;
2. Aged 18-50 years;
3. Complicated with sarcopenia;
4. Willing and able to tolerate oral exclusive enteral nutrition (EEN) therapy;
5. Signed informed consent and able to comply with the study procedures;
6. Colonic or ileocolonic type CD (SES-CD ≥6; if only terminal ileum is involved, SES-CD ≥4).
Exclusion Criteria:
1. Short bowel syndrome;
2. High-output jejunal fistula;
3. Severe stress or shock status;
4. Complete mechanical intestinal obstruction, acute gastrointestinal bleeding, or severe intra-abdominal infection;
5. Severe hepatic, renal, or cardiac diseases, or malignant tumors;
6. History of allergy or contraindication to Ensure or HMB;
7. Persistent severe vomiting or intractable diarrhea;
8. Congenital disorders of sugar or amino acid metabolism;
9. 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.
Primary outcome measure(s)
- muscle strength improvement — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Sixth Hospital Affiliated to Sun Yat-sen University | Guangzhou | Guangdong |
More Sixth Affiliated Hospital, Sun Yat-sen University trials in China
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07171593 on ClinicalTrials.gov ↗ ← All trials in China