Partial Enteral Nutrition Effects on Weight Loss and Sarcopenia in Patients With IBD at Risk of Caloric-Protein Malnutrition - SIMBA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 4
- 主要终点
- Proportion of participants achieving maintenance or increase in body weight ≥1 kg from baseline
研究概览
简要总结
This is a multicenter, open-label, randomized two-arm interventional nutritional study evaluating the effects of partial enteral nutrition (LH VIOLA) in patients with Inflammatory Bowel Disease (IBD) at risk of malnutrition. A total of 146 patients (73 per arm) will be enrolled across 4 centers.
IBD, including Crohn's Disease and Ulcerative Colitis, is associated with malabsorption, weight loss, sarcopenia, and malnutrition, which negatively impact quality of life and treatment outcomes. Nutritional assessment using the Malnutrition Universal Screening Tool (MUST) will identify patients at risk.
Participants will be randomized to receive either nutritional counseling alone or counseling plus oral LH VIOLA supplementation (≥412 kcal/day) for 16 weeks. The primary objective is to evaluate maintenance or recovery of body weight at 16 weeks. Secondary objectives include assessment of weight at 24 weeks, muscle strength (handgrip), body composition and metabolic parameters (BIA/BIVA, vitamin B12/D, pre-albumin), quality of life (SF-12), economic impact, adherence, gastrointestinal tolerability, and reduction in malnutrition risk (MUST score).
The study duration per patient is 24 weeks (16 weeks of intervention plus 8 weeks follow-up), with a total study duration of 18 months. The sample size is powered to detect an increase from 40% to 65% in patients achieving weight maintenance or gain at 16 weeks, accounting for a 15% dropout rate.
详细描述
Background:
Inflammatory Bowel Disease (IBD), including Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic immune-mediated condition characterized by relapsing and remitting courses. Patients with IBD, particularly those with Crohn's Disease, are at risk of malabsorption of vitamins (B12, D), minerals (calcium, iron), anemia, and sarcopenia, leading to malnutrition. Malnutrition negatively affects quality of life, response to therapy, and increases the risk of hospitalization and surgical interventions. ESPEN guidelines recommend regular nutritional assessment and targeted interventions for patients at risk of malnutrition.
The Malnutrition Universal Screening Tool (MUST) will be used to identify patients at nutritional risk. Other nutritional assessments include anthropometric measures, body composition analysis (BIA/BIVA), handgrip strength evaluation, and laboratory tests (vitamins B12/D, pre-albumin). Despite these recommendations, the effect of partial enteral nutrition using a specialized medical food (LH VIOLA) on body weight, muscle mass, and disease activity in patients with IBD at nutritional risk has not been fully investigated.
Study Objectives:
Primary Objective: Evaluate the maintenance or recovery of body weight after 16 weeks of LH VIOLA supplementation, measured in kilograms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Diagnosis of Crohn's Disease or Ulcerative Colitis
- •At risk of malnutrition according to the Malnutrition Universal Screening Tool (MUST)
- •Ability to provide informed consent
- •Women of childbearing potential must use effective contraception
排除标准
- •Following an exclusion diet (CDED)
- •Current hospitalization
- •Pregnancy
- •Requirement for a low-protein diet
研究组 & 干预措施
Control Arm
Nutritional counseling alone. Patients receive standard nutritional counseling delivered by a clinical dietitian.
Experimental Arm
Nutritional counseling + LH VIOLA oral supplementation. Patients receive ≥412 kcal/day of LH VIOLA for 16 weeks, in addition to standard nutritional counseling delivered by a clinical dietitian.
干预措施: LH VIOLA Supplementation (Dietary Supplement)
结局指标
主要结局
Proportion of participants achieving maintenance or increase in body weight ≥1 kg from baseline
时间窗: 16 weeks
Weight measured in kilograms at baseline (T0) and after 16 weeks of intervention. Participants who do not maintain or increase their weight by ≥1 kg will be considered as not achieving the primary endpoint.
次要结局
- Weight maintenance or improvement at 24 weeks(24 weeks)
- Muscle mass recovery or maintenance (handgrip strength)(16 and 24 weeks)
- Body composition and metabolic parameters (BIA/BIVA, vitamins B12/D, pre-albumin)(16 and 24 weeks)
- Economic impact(24 weeks)
- Quality of life (SF-12 questionnaire)(24 weeks)
- Adherence to nutritional intervention (≥50% of prescribed supplement intake)(16 weeks)
- Gastrointestinal tolerability(16 weeks)
- Reduction in malnutrition risk (MUST score)(16 and 24 weeks)