Ulcerative Colitis
Conditions
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.
Interventions
OTHERHigh 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.
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal H2S Production | Week 4 | Assessed from stool samples |
Countries
United States
Contacts
CONTACTLulu Chen
PRINCIPAL_INVESTIGATORLevi Teigen
University of Minnesota
Outcome results
None listed