Ulcerative ColitisNCT05507931
Broccoli Sprouts for Mild Ulcerative Colitis
A study testing 1 Serving of broccoli sprouts and 3 Servings of broccoli sprouts in people with Ulcerative Colitis and Ulcerative Colitis Chronic Mild, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Ulcerative Colitis Chronic Mild
- What is being tested?
- 1 Serving of broccoli sprouts and 3 Servings of broccoli sprouts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 9 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Feasibility Study to Develop a Broccoli Sprouts-enriched Diet in the Management of Ulcerative Colitis
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.
- Being tested
- 1 Serving of broccoli sprouts, 3 Servings of broccoli sprouts
- Keywords
- sulforaphane, inflammatory markers, Inflammatory bowel disease, diet, ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 Serving of broccoli sproutsDietary supplement
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.
3 Servings of broccoli sproutsDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 Serving of broccoli sprouts | Experimental | 113 grams Receives: Dietary Supplement: 1 Serving of broccoli sprouts |
| 3 Servings of broccoli sprouts | Experimental | 339 grams Receives: Dietary Supplement: 3 Servings of broccoli sprouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 28
Levels of sulforaphane in the stool
Level recorded in micrograms/gram.
Measured: Day 28
Levels of sulforaphane in the blood
Level recorded in micrograms/gram.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start23 May 2023
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maine
- Responsible party
- Principal investigator, Grace Chen, University of Michigan
- Investigators
- Grace Chen, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507931
- Sponsor's protocol ID
- HUM00210637
- Other IDs
- 2022-67017-36303
- Status last verified
- Jan 2026
- First submitted
- 17 Aug 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study to Develop a Broccoli Sprouts-enriched Diet in the Management of Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05507931
- Acronym / sponsor ID
- HUM00210637
- Keywords
- sulforaphane, inflammatory markers, Inflammatory bowel disease, diet, ulcerative colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Maine
- Study start
- 23 May 2023 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Serving of broccoli sprouts | Experimental | Dietary Supplement: 1 Serving of broccoli sprouts113 grams |
| 3 Servings of broccoli sprouts | Experimental | Dietary Supplement: 3 Servings of broccoli sprouts339 grams |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 Serving of broccoli sproutsParticipants 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. | Dietary supplement | 1 Serving of broccoli sprouts |
| 3 Servings of broccoli sproutsParticipants 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. | Dietary supplement | 3 Servings of broccoli sprouts |
Primary outcome
Feasibility of adopting a steamed broccoli diet in patients with ulcerative colitis as measured by self report of difficulty eating broccoli sprouts.
Time frame: Day 28
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.
Feasibility of adopting a steamed broccoli diet in patients with inflammatory bowel disease ulcerative colitis as measured by participant compliance.
Time frame: Day 28
Compliance is collected through self-report of the number of servings consumed.
Levels of sulforaphane in the stool
Time frame: Day 28
Level recorded in micrograms/gram.
Levels of sulforaphane in the blood
Time frame: Day 28
Level recorded in micrograms/gram.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Chen principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 Serving of broccoli sprouts and 3 Servings of broccoli sprouts in people with Ulcerative Colitis and Ulcerative Colitis Chronic Mild, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of adopting a steamed broccoli diet in patients with ulcerative colitis as measured by self report of difficulty eating broccoli sprouts. (time frame: Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.