Ulcerative Colitis, Ulcerative Colitis Chronic Mild
Conditions
Keywords
sulforaphane, inflammatory markers, Inflammatory bowel disease, diet, ulcerative colitis
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.
Interventions
DIETARY_SUPPLEMENT1 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.
DIETARY_SUPPLEMENT3 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.
Sponsors
University of Michigan
University of Maine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGrace Chen
University of Michigan
Outcome results
None listed