High-protein Oral Nutrition With HMB for Active CD Patients With Sarcopenia

NCT07171593 | Enrolling By Invitation

• 1 other identifier: 2023-077
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy of B-hydroxy-β-methybutyrate in sarcopenia

Conditions

Handgrip Strength

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 4; Week 8

Secondary Outcomes (5)

• Improvement of muscle mass

  Week 4; Week 8

• Clinical response

  Week 4; Week 8

• Clinical remission

  Week 4; Week 8

• Mucosal healing

  Week 4; Week 8

• Clinical relapse

  Week 4; Week 8

Study Arms (2)

Control

NO INTERVENTION

EEN

Experiment

EXPERIMENTAL

EEN+HMB

Dietary Supplement: HMB

Interventions

HMB DIETARY_SUPPLEMENT

EEN+HMB

Experiment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Sixth Hospital Affiliated to Sun Yat-sen University

Guangzhou, Guangdong, 570000, China

Location

Study Officials

• Kang Chao

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: September 12, 2025
• Study Start: March 4, 2024
• Primary Completion: May 22, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

CN (1)