Broccoli Sprouts for Mild Ulcerative Colitis
A Pilot Feasibility Study to Develop a Broccoli Sprouts-enriched Diet in the Management of Ulcerative Colitis
2 other identifiers
interventional
23
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2022
CompletedFirst Posted
Study publicly available on registry
August 19, 2022
CompletedStudy Start
First participant enrolled
May 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2026
CompletedJanuary 23, 2026
January 1, 2026
2.6 years
August 17, 2022
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Feasibility of adopting a steamed broccoli diet in patients with ulcerative colitis as measured by self report of difficulty eating broccoli sprouts.
Self report documented in the end of study questionnaire. The questionnaire has 11 questions with the feasibility specifically linked to question 7, "how difficult was it to eat broccoli sprouts?" The answers range from 'not at all' (1) to 'very hard' (5) on a likert like scale.
Day 28
Feasibility of adopting a steamed broccoli diet in patients with inflammatory bowel disease ulcerative colitis as measured by participant compliance.
Compliance is collected through self-report of the number of servings consumed.
Day 28
Levels of sulforaphane in the stool
Level recorded in micrograms/gram.
Day 28
Levels of sulforaphane in the blood
Level recorded in micrograms/gram.
Day 28
Study Arms (2)
1 Serving of broccoli sprouts
EXPERIMENTAL113 grams
3 Servings of broccoli sprouts
EXPERIMENTAL339 grams
Interventions
Participants will take 1 serving of broccoli sprouts daily for 28 days. The sprouts will be provided by the study team along with instructions on how to prepare the steamed broccoli sprouts (i.e., steamed for 10 minutes). In addition to taking the sprouts, participants will be asked to complete food diaries and surveys, collect blood and stool samples, as well as having 2 in-person visits.
Participants will take 3 servings of broccoli a day for 28 days. The sprouts will be provided by the study team along with instructions on how to prepare the steamed broccoli sprouts (i.e., steamed for 10 minutes). In addition to taking the sprouts, participants will be asked to complete food diaries and surveys, collect blood and stool samples, as well as having 2 in-person visits.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Taking Non-steroidal anti-inflammatory drugs (NSAIDs)
- Following a medically-prescribed diet, on Total parenteral nutrition (TPN), or tube feeds
- Newly diagnosed (within past month), or uncontrolled diabetes or cardiovascular disease
- Antibiotics in the previous 2 weeks
- Consumption of more than 5 ½ cups of servings/day of fruits and vegetables as assessed by the National Cancer Institute (NCI) Diet History Questionaire III online Food Questionnaire.
- A known allergy or sensitivity to cruciferous vegetables like arugula, bok choy, broccoli, cabbage, cauliflower, or collard greens
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- University of Mainecollaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grace Chen
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Internal Medicine
Study Record Dates
First Submitted
August 17, 2022
First Posted
August 19, 2022
Study Start
May 23, 2023
Primary Completion
January 9, 2026
Study Completion
January 9, 2026
Last Updated
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share