A Pilot Feasibility Study to Develop a Broccoli Sprouts-enriched Diet in the Management of Ulcerative Colitis

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this study is to determine the number of servings of broccoli sprouts sufficient to (1) increase sulforaphane levels in the stool and blood and (2) reduce inflammatory markers in patients with mild ulcerative colitis. This is a pilot feasibility study to prepare for a larger randomized controlled trial.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Documented endoscopic diagnosis of ulcerative colitis

• Currently being treated with a stable dose of 5-ASAs, steroids, or any other medication approved for ulcerative colitis

‣ If on 5-ASA, no dose changes within 2 weeks before the Day 0 visit

⁃ If on steroids, prednisone dose not more than 20 mg daily and entocort not more than 9 mg daily, with no dose changes within 2 weeks before the Day 0 visit

⁃ All other medications require a stable dose for at least 8 weeks prior to enrollment.

⁃ No dose changes to any IBD medication anticipated for the duration of the study

• Body Mass Index (BMI) values 18.5-40 kg/m2

• Not on total parenteral nutrition (TPN) or receiving tube feeds.

• Ability to understand the study procedures, benefits and risks, and sign a written informed consent document.

• Able to fill out questionnaires regarding dietary intakes, bowel symptoms, and study experience

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Kelli Porzondek
kporzond@med.umich.edu
734-764-0507
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Experimental: 1 Serving of broccoli sprouts
113 grams
Experimental: 3 Servings of broccoli sprouts
339 grams
Sponsors
Leads: University of Michigan
Collaborators: University of Maine

This content was sourced from clinicaltrials.gov