Broccoli Sprouts for Mild Ulcerative Colitis

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis; Ulcerative Colitis Chronic Mild
• Intervention / Treatment: Dietary supplement: 1 Serving of broccoli sprouts; Dietary supplement: 3 Servings of broccoli sprouts

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 Serving of broccoli sprouts; 113 grams	Dietary supplement: 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.
Experimental: 3 Servings of broccoli sprouts; 339 grams	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: University of Maine
• Investigators: Principal Investigator: Grace Chen, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): January 9, 2026
• Study Completion (Actual): January 9, 2026

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ulcerative colitis; diet; Inflammatory bowel disease; sulforaphane; inflammatory markers
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases
• Other Study ID Numbers: HUM00210637; 2022-67017-36303 (Other Grant/Funding Number: USDA National Institute of Food and Agriculture (NIFA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No