High Protein, High Fiber Diet for Ulcerative Colitis
Official title: Microbiome-targeted Diet Therapy in Ulcerative Colitis
Run by University of Minnesota · NCT07520461 · Data updated 2026-11-12
This study tests a high-protein, high-fiber diet to see if it helps people with ulcerative colitis by meeting protein needs and lowering harmful hydrogen sulfide production in the gut.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | November 4, 2026 |
| Main results expected | June 1, 2029 |
| Study ends | June 1, 2029 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07520461 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with a confirmed UC diagnosis, UC duration of at least 3 months, mild or inactive disease (UCEIS ≤4), and stable or no UC therapy aside from steroids.
✕Probably not a fit
Individuals with moderate to severe UC, intolerance to high-fiber diets, recent antibiotic exposure, or other exclusions may not benefit from this diet approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial evaluates a novel diet that combines elevated protein intake with increased fiber to support nutritional needs in adults with ulcerative colitis. Participants will follow the High Protein, High Fiber (HPHF) diet and will be followed for changes in disease activity and gut health. The study will enroll adults with UC who have mild or inactive disease as defined by UCEIS and are on a stable or no UC therapy other than steroids. Key eligibility requires confirmed UC diagnosis, duration of at least 3 months, and the ability to comply with study requirements. Exclusion criteria include moderate to severe UC, recent antibiotic use, pregnancy, and dietary fiber intolerance, among others.
Why it matters
Potential benefit: If successful, participants might experience better disease control and nutritional balance through a gut-friendly diet.
How similar studies have gone: Prior dietary approaches in UC have shown variable success; this study explores a specific high-protein, high-fiber approach with a focus on reducing colonic hydrogen sulfide production, which remains a novel angle in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability and willingness to provide informed consent * Age at least 18 years old * Diagnosis of UC based on clinical and endoscopic criteria * UC duration of at least 3 months * Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≤4 within 90 days of randomization * On a stable dose or no existing UC therapies (apart from steroids) for defined periods (as outlined below). 1. ≥4 weeks if no medication, 5-ASA 2. ≥8 wk for immunomodulatory therapy 3. ≥12 wk for biologics * Ability to comply with study requirements in the opinion of the primary investigator Exclusion Criteria: * Moderate or severe UC as defined by UCEIS ≥5 * History of stomach surgery or bowel resection * Antibiotic use within 3 months * Anticipated antibiotic exposure during the study period (e.g. perioperative antibiotics) * Pregnancy or breastfeeding * History of anaphylactic food allergies * Intolerance of high dietary fiber content * Ongoing alcohol or drug abuse * Habitual vegan diet pattern * Insufficient freezer space to accommodate meal delivery
Where it's running
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University Of Minnesota
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Levi Teigen — University of Minnesota
- Study coordinator: Lulu Chen
- Email: chen8124@umn.edu
- Phone: 612-301-8294
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.