Efficacy of High-protein Oral Enteral Nutrition Supplement Supplemented With HMB in Active Crohn's Disease With Sarcopenia: a Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- muscle strength improvement
研究概览
简要总结
The efficacy of B-hydroxy-β-methybutyrate in sarcopenia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
muscle strength improvement
时间窗: 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.
次要结局
- 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)
研究者
Chao Kang
Clinical professor
Sixth Affiliated Hospital, Sun Yat-sen University