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

ConditionsUlcerative Colitis (Disorder)Crohn DiseaseMalnutrition or Risk of MalnutritionIBD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLionhealth Srl Società Benefit

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Following an exclusion diet (CDED)

Current hospitalization

Pregnancy

Requirement for a low-protein diet

Trial design

Design model

Parallel

Treatments tested in this trial

  • LH VIOLA Supplementation

    Dietary supplement

    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.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Experimental ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proportion of participants with change in body weight from baseline at 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 - 16 weeks

Secondary outcomes

1

Change in body weight at 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 - 24 weeks
2

Change in handgrip strength from baseline to follow-up

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
3

Body composition (BIA)

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
Baseline - 16 and 24 weeks
4

Change in total direct and indirect healthcare costs from baseline

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lionhealth Srl Società Benefit

Lead sponsor

Source ClinicalTrials.gov
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