Broccoli Sprouts for Mild Ulcerative Colitis

Study Overview
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Brief Summary
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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.

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

Conditions
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Ulcerative Colitis, Ulcerative Colitis Chronic Mild

Intervention / Treatment
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* Dietary Supplement: 1 Serving of broccoli sprouts
* Dietary Supplement: 3 Servings of broccoli sprouts


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Serving of broccoli sprouts<br>113 grams | Dietary Supplement: 1 Serving of broccoli sprouts<br>* 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.<br>|
| Experimental: 3 Servings of broccoli sprouts<br>339 grams | Dietary Supplement: 3 Servings of broccoli sprouts<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sulforaphane, inflammatory markers, Inflammatory bowel disease, diet, ulcerative colitis