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Enrolling by Invitation

NCT Number: NCT07171593

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

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

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Key information

Conditions

Handgrip Strength

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sixth Hospital Affiliated to Sun Yat-sen University

Guangzhou, Guangdong, 570000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

HMB

Dietary Supplement

EEN+HMB

Primary outcomes

  1. 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.

Secondary outcomes

  1. Improvement of muscle mass

    Time frame: Week 4; Week 8

    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.

  2. Clinical response

    Time frame: Week 4; Week 8

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

  3. Clinical remission

    Time frame: Week 4; Week 8

    CDAI <150.

  4. Mucosal healing

    Time frame: Week 4; Week 8

    No visible ulcers on endoscopy.

  5. Clinical relapse

    Time frame: Week 4; Week 8

    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.

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Efficacy of High-protein Oral Enteral Nutrition Supplement Supplemented With HMB in Active Crohn's Disease With Sarcopenia: a Prospective, Randomized, Controlled Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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