Broccoli Sprouts for Mild Ulcerative Colitis

NCT ID: NCT05507931

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2026-01-09

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.

Conditions

Ulcerative Colitis; Ulcerative Colitis Chronic Mild

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 Serving of broccoli sprouts

113 grams

Group Type: EXPERIMENTAL

1 Serving of broccoli sprouts

Intervention Type: DIETARY_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 sprouts

339 grams

Group Type: EXPERIMENTAL

3 Servings of broccoli sprouts

Intervention Type: DIETARY_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.

Interventions

1 Serving of broccoli sprouts

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.

Intervention Type: DIETARY_SUPPLEMENT

3 Servings of broccoli sprouts

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maine

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Grace Chen

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grace Chen

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2022-67017-36303

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HUM00210637

Identifier Type: -

Identifier Source: org_study_id