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NCT Number: NCT05507931

Broccoli Sprouts for Mild 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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis Chronic Mild

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1 Serving of broccoli sprouts

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Levels of sulforaphane in the stool

    Time frame: Day 28

    Level recorded in micrograms/gram.

  4. Levels of sulforaphane in the blood

    Time frame: Day 28

    Level recorded in micrograms/gram.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • University of Maine

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2022
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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