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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.
Full description
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.
Secondary Objectives: Evaluate weight maintenance or improvement at 24 weeks; assess muscle mass recovery or maintenance (handgrip strength); assess body composition and metabolic parameters (BIA/BIVA, vitamin B12/D, pre-albumin); evaluate quality of life (SF-12 questionnaire); assess economic impact; evaluate adherence to nutritional intervention (≥50% intake); assess gastrointestinal tolerability; evaluate reduction in malnutrition risk (MUST score).
Study Design:
This is a multicenter, open-label, randomized, two-arm interventional nutritional study. A total of 146 patients (73 per arm, including a 15% anticipated dropout) will be enrolled across 4 centers. Patients will be randomized 1:1 to either:
Nutritional counseling alone (control arm)
Nutritional counseling plus oral LH VIOLA supplementation (≥412 kcal/day for 16 weeks) (intervention arm)
Procedures and Follow-up:
Patients will undergo an initial screening, a baseline visit (T0), a telephone follow-up (T1) at the start of product intake, a second hospital visit (T2), a second telephone follow-up (T3), a third hospital visit (T4) at week 16 to complete product intake, and a final follow-up visit (T5) at week 24. During visits, patients will undergo assessments of body weight, body composition, muscle strength, biochemical parameters, and quality of life questionnaires. Adherence and tolerability to LH VIOLA will be monitored.
Study Duration:
Each participant will be involved for 24 weeks (16 weeks of intervention plus 8 weeks of follow-up). The total study duration is 18 months, including 12 months for patient recruitment and 6 months for follow-up.
Statistical Plan and Sample Size:
The sample size is calculated based on the primary endpoint: proportion of patients maintaining or gaining weight at 16 weeks. The study aims to detect an increase from 40% (control) to 65% (intervention), with an alpha of 5% and 80% power, considering a 1:1 randomization. Accounting for a 15% dropout rate, 146 patients will be enrolled (73 per arm).
Significance:
This study will provide critical evidence on the efficacy of partial enteral nutrition using LH VIOLA in preventing weight loss, preserving muscle mass, and improving metabolic and quality of life outcomes in patients with IBD at risk of malnutrition. It will support evidence-based nutritional interventions and inform clinical guidelines for nutritional management in IBD.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age 18-65 years
Diagnosis of Crohn's Disease or Ulcerative Colitis
At risk of malnutrition according to MUST screening
Ability to provide informed consent
Women of childbearing potential must use effective contraception
Exclusion criteria
Following an exclusion diet (CDED)
Current hospitalization
Pregnancy
Requirement for a low-protein diet
Primary purpose
Allocation
Interventional model
Masking
146 participants in 2 patient groups
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Central trial contact
Lucio Vitiello, Biological Sciences; Roberta Majer, Pharmaceutical Chemistry and T
Data sourced from clinicaltrials.gov
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