Broccoli Sprouts for Mild Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507931
• Other study ID #: HUM00210637
• Secondary ID: 2022-67017-36303
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: September 2025

Study information

• Verified date: July 2023
• Source: University of Michigan
• Contact: Andy Brosius
• Phone: 734-647-4548
• Email: abrosius[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented endoscopic diagnosis of ulcerative colitis
• Mild ulcerative colitis based on endoscopic findings and/or fecal calprotectin levels=50-500 mg/g stool.
• Currently being treated with a stable dose of 5-ASAs, steroids, Imuran, Remicade, or

Humira, defined as such:

• 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
• If on Imuran, Remicade, or Humira, no dose changes within 8 weeks before the Day 0 visit
• 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) or biologic/immunomodulatory therapies
• 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis
• Ulcerative Colitis Chronic Mild

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	University of Maine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Levels of sulforaphane in the stool	Level recorded in micrograms/gram.	Day 28
Primary	Levels of sulforaphane in the blood	Level recorded in micrograms/gram.	Day 28