Broccoli Sprouts for Mild Ulcerative Colitis
Primary Purpose
Ulcerative Colitis, Ulcerative Colitis Chronic Mild
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1 Serving of broccoli sprouts
3 Servings of broccoli sprouts
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring sulforaphane, inflammatory markers, Inflammatory bowel disease, diet, ulcerative colitis
Eligibility Criteria
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 Aminosalicylic acids (5-ASA) for past 2 weeks
- If on steroids, prednisone dose not more than 20 mg daily and entocort not more than 9 mg daily.
- If on Imuran, must have been on stable dose for at least 8 weeks
- 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
- Changes in dose of 5-ASA within past 2 weeks
- People eating 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.
- BMI <18.5 or >40 kg/m2
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1 Serving of broccoli sprouts
3 Servings of broccoli sprouts
Arm Description
113 grams
339 grams
Outcomes
Primary Outcome Measures
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.
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.
Levels of sulforaphane in the stool
Level recorded in micrograms/gram.
Levels of sulforaphane in the blood
Level recorded in micrograms/gram.
Secondary Outcome Measures
Full Information
NCT ID
NCT05507931
First Posted
August 17, 2022
Last Updated
July 21, 2023
Sponsor
University of Michigan
Collaborators
University of Maine
1. Study Identification
Unique Protocol Identification Number
NCT05507931
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
University of Maine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Ulcerative Colitis Chronic Mild
Keywords
sulforaphane, inflammatory markers, Inflammatory bowel disease, diet, ulcerative colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 Serving of broccoli sprouts
Arm Type
Experimental
Arm Description
113 grams
Arm Title
3 Servings of broccoli sprouts
Arm Type
Experimental
Arm Description
339 grams
Intervention Type
Dietary Supplement
Intervention Name(s)
1 Serving of broccoli sprouts
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
3 Servings of broccoli sprouts
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of adopting a steamed broccoli diet in patients with ulcerative colitis as measured by self report of difficulty eating broccoli sprouts.
Description
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.
Time Frame
Day 28
Title
Feasibility of adopting a steamed broccoli diet in patients with inflammatory bowel disease ulcerative colitis as measured by participant compliance.
Description
Compliance is collected through self-report of the number of servings consumed.
Time Frame
Day 28
Title
Levels of sulforaphane in the stool
Description
Level recorded in micrograms/gram.
Time Frame
Day 28
Title
Levels of sulforaphane in the blood
Description
Level recorded in micrograms/gram.
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andy Brosius
Phone
734-647-4548
Email
abrosius@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Chen
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelli Porzondek
Phone
734-764-0507
Email
kporzond@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Grace Chen
12. IPD Sharing Statement
Plan to Share IPD
No
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Broccoli Sprouts for Mild Ulcerative Colitis
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