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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Other: 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.

Recruiting Locations

University Of Minnesota
Minneapolis, Minnesota 55455
Contact:
Levi Teigen

More Details

Status
Recruiting
Sponsor
University of Minnesota

Study Contact

Lulu Chen
612-301-8294
chen8124@umn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.