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

N/AEnrolling By InvitationNCT07171593

Sixth Affiliated Hospital, Sun Yat-sen University44 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Handgrip Strength

Interventions

HMBDIETARY_SUPPLEMENT

EEN+HMB

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sixth Hospital Affiliated to Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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.

Time frame: Week 4; Week 8

Secondary Outcomes

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.

Time frame: Week 4; Week 8

Clinical response

A decrease in the Crohn's Disease Activity Index (CDAI) by ≥70 points or a CDAI \<150.

Time frame: Week 4; Week 8

Clinical remission

CDAI \<150.

Time frame: Week 4; Week 8

Mucosal healing

No visible ulcers on endoscopy.

Time frame: 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.

Data from ClinicalTrials.gov

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