Plain-English translation of NCT07433946 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing whether a specialized medical food called LH VIOLA can help people with inflammatory bowel disease (IBD) — either Crohn's disease or ulcerative colitis — maintain or regain their body weight and muscle mass over 16 weeks. Some participants will receive this medication along with personalized nutrition counseling from a dietitian, while others will receive counseling alone. The study wants to see if the treatment helps prevent the weight loss and muscle weakness that often happens to people with IBD.
People with IBD often lose weight and muscle mass because their disease makes it hard for their bodies to absorb nutrients properly. This can make their symptoms worse, reduce their quality of life, and increase the need for hospitalization or surgery. While experts recommend nutritional support for these patients, it's not yet clear whether this specific treatment actually works to prevent these serious complications.
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If you join this study, you'll be randomly assigned to either receive the specialized nutritional drink along with dietitian counseling, or to receive dietitian counseling alone. The active treatment lasts 16 weeks, and you'll need to drink at least 412 calories per day of the supplement if you're in the treatment group. You'll visit the study center for assessments that measure your weight, muscle strength, body composition, blood vitamin levels, and how you're feeling overall — these visits will happen at the beginning, at 16 weeks, and at 24 weeks.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
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