Clinical trial NCT05507931: Broccoli Sprouts for Mild Ulcerative Colitis
Official title: A Pilot Feasibility Study to Develop a Broccoli Sprouts-enriched Diet in the Management of Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Ulcerative Colitis Chronic Mild
Keywords: sulforaphane
inflammatory markers
Inflammatory bowel disease
diet
ulcerative colitis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of Maine
First posted: 2022-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of adopting a steamed broccoli diet in patients with ulcerative colitis as measured by self report of difficulty eating broccoli sprouts.
timeFrame: Day 28
measure: Feasibility of adopting a steamed broccoli diet in patients with inflammatory bowel disease ulcerative colitis as measured by participant compliance.
timeFrame: Day 28
measure: Levels of sulforaphane in the stool
timeFrame: Day 28
measure: Levels of sulforaphane in the blood
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Grace Chen
role: PRINCIPAL_INVESTIGATOR
References: