Effects of Partial Enteral Nutrition With LH VIOLA on Weight Loss and Muscle Loss in Adults With Inflammatory Bowel Disease at Nutritional Risk

What this Trial Is About

Researchers are evaluating the effects of partial enteral nutrition using LH VIOLA in patients with Inflammatory Bowel Disease IBD who are at risk of malnutrition. This interventional, randomized, open-label study includes 146 participants with Crohns Disease or Ulcerative Colitis. The study aims to assess whether LH VIOLA supplementation can help maintain or recover body weight, muscle strength, and improve nutritional status, quality of life, and economic outcomes over 16 weeks, followed by an 8-week follow-up. Participants will be randomly assigned to one of two groups one group will receive standard nutritional counseling alone, while the other group will receive nutritional counseling plus oral LH VIOLA supplementation providing at least 412 kcal per day for 16 weeks. The study includes multiple visits and telephone follow-ups during the intervention period, with assessments and monitoring of adherence, tolerability, body composition, muscle strength, and biochemical markers. During the 24-week participation, patients will undergo screening, baseline assessments, follow-up calls, and hospital visits to measure body weight, muscle strength, body composition using BIABIVA, vitamin levels, and quality of life questionnaires SF-12. Researchers will monitor gastrointestinal tolerability, adherence to supplementation, and changes in malnutrition risk MUST score. The study lasts 18 months overall, including recruitment and follow-up, with the primary outcome focused on weight change at 16 weeks.

Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA