Broccoli Sprouts for Mild Ulcerative Colitis

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis; Ulcerative Colitis Chronic Mild
• Interventions: Dietary Supplement: 3 Servings of broccoli sprouts; Dietary Supplement: 1 Serving of broccoli sprouts

• Registration Number: NCT05507931
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-17
• Study First Posted: 2022-08-19
• Study Start: 2023-05-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 Servings of broccoli sprouts	3 Servings of broccoli sprouts	339 grams
1 Serving of broccoli sprouts	1 Serving of broccoli sprouts	113 grams

Primary Outcome Measures

Name	Time	Method
Levels of sulforaphane in the stool	Day 28	Level recorded in micrograms/gram.
Levels of sulforaphane in the blood	Day 28	Level recorded in micrograms/gram.
Feasibility of adopting a steamed broccoli diet in patients with ulcerative colitis as measured by self report of difficulty eating broccoli sprouts.	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.	Day 28	Compliance is collected through self-report of the number of servings consumed.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States