Recruiting

Diet with Fiber

Sponsor:

University of Minnesota

Code:

NCT07520461

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High Protein, High Fiber (HPHF) Diet

Study Details

Brief summary:

The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.

Conditions

Ulcerative Colitis

Study ID

NCT07520461

Start date

Sep 26, 2026

Status verified date

Sep, 2026

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: On-Off Cycling Intervention

1 week standard diet, followed by

1 week high-protein, high-fiber diet, followed by

1 week standard diet, followed by

1 week high-protein, high-fiber diet

Interventions

High Protein, High Fiber (HPHF) Diet

The HPHF diet is a diet designed to maximize the intake of proteins and fermentable dietary fibers. Frozen meals are provided to participants weekly and consumed over two non-consecutive 7-day periods.

Primary outcome measure

  • Fecal H2S Production [ Time Frame: Week 4 ]

Central Contacts and Locations

Central contacts

Lulu Chen

612-301-8294chen8124@umn.edu

Locations

University Of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

More Information

Sponsor

University of Minnesota

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-09-14.