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

Sun Yat-sen University

Status: Invitation-only

Conditions: Handgrip Strength

Treatments: Dietary Supplement: HMB

Study type: Interventional

Funder types: Other

Identifiers

NCT07171593

2023-077

Details and patient eligibility

About

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

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Control

No Intervention group

Description:

EEN

Experiment

Experimental group

Description:

EEN+HMB

Treatment:

Dietary Supplement: HMB