NCT Number: NCT07433946
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
IRCCS Humanitas, Rozzano, Milano, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral administration of LH VIOLA, a specialized medical food (≥412 kcal/day), for 16 weeks, together with nutritional counseling provided by a clinical dietitian. Participants monitored for adherence, tolerability, weight, body composition, and muscle strength.
Time frame: Baseline - 16 weeks
Body weight will be measured in kilograms at baseline (T0) and at 16 weeks. The outcome is defined as the proportion of participants with a change in body weight greater than or equal to +1 kg from baseline.
Time frame: Baseline - 24 weeks
Body weight will be measured in kilograms at baseline (T0) and at 24 weeks. Change in body weight is defined as the difference between the 24-week and baseline measurements. Positive values indicate an increase in body weight, and negative values indicate a decrease.
Time frame: Baseline - 16 and 24 weeks
Handgrip strength will be measured in kilograms using a dynamometer at baseline and follow-up visits. Change in handgrip strength is defined as the difference between follow-up and baseline measurements. Higher values indicate greater muscle strength.
Time frame: Baseline - 16 and 24 weeks
Body composition will be assessed using bioelectrical impedance analysis (BIA) at baseline and follow-up visits. Parameters include fat mass and fat-free mass, expressed in kilograms and percentage.
Time frame: 24 weeks
Total direct and indirect healthcare costs associated with IBD management will be collected for each participant in both study arms. Costs will include hospitalizations, outpatient visits, medications, and indirect costs (e.g., lost work days), expressed in local currency (e.g., USD or EUR) over the 24-week study period
Time frame: 24 weeks
The Physical Component Summary (PCS) score of the 12-Item Short Form Health Survey (SF-12), range 0-100; higher scores indicate better physical health status. The PCS score will be assessed at baseline, 16 weeks, and 24 weeks.
Time frame: 24 weeks
The Mental Component Summary (MCS) score of the 12-Item Short Form Health Survey (SF-12), range 0-100; higher scores indicate better mental health status. The MCS score will be assessed at baseline, 16 weeks, and 24 weeks.
Time frame: 16 weeks
Adherence to the prescribed LH VIOLA supplement will be assessed at each follow-up visit. The outcome is defined as the proportion of participants consuming at least 50% of the prescribed daily dose over the study period (baseline to 24 weeks)
Time frame: 16 weeks
Gastrointestinal (GI) symptoms including nausea, diarrhea, bloating, and abdominal pain will be recorded at each study visit and follow-up. Severity will be graded on a standardized 0-3 scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). Time Frame: baseline to 24 weeks
Time frame: Baseline - 16 and 24 weeks
Malnutrition risk will be assessed using the Malnutrition Universal Screening Tool (MUST; score range 0-6) at baseline, 16 weeks, and 24 weeks. MUST is a validated screening tool used to identify risk of malnutrition.
Scores range from 0 to 6, where higher scores indicate a greater risk of malnutrition
Time frame: Baseline - 16 - 24 Weeks
Serum vitamin B12 levels will be measured at baseline and follow-up visits. Concentrations will be expressed in pg/mL.
Time frame: Baseline - 16 - 24 weeks
Serum 25-hydroxyvitamin D levels will be measured at baseline and follow-up visits and expressed in ng/mL.
Time frame: Baseline - 16 - 24 weeks
Serum prealbumin levels will be measured at baseline and follow-up visits and expressed in mg/dL.
Contact information is provided by the study sponsor or research team.
Lucio Vitiello, Biological Sciences
CONTACT
Roberta Majer, Pharmaceutical Chemistry and T
CONTACT
Lionhealth Srl Società Benefit
Industry
Partial Enteral Nutrition Effects on Weight Loss and Sarcopenia in Patients With IBD at Risk of Caloric-Protein Malnutrition - SIMBA
Acronym: SIMBA
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