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Broccoli Sprouts for Mild Ulcerative Colitis

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Ulcerative Colitis Chronic Mild
Ulcerative Colitis

Treatments

Dietary Supplement: 3 Servings of broccoli sprouts
Dietary Supplement: 1 Serving of broccoli sprouts

Study type

Interventional

Funder types

Other

Identifiers

NCT05507931
HUM00210637
2022-67017-36303 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

23 participants in 2 patient groups

1 Serving of broccoli sprouts
Experimental group
Description:
113 grams
Treatment:
Dietary Supplement: 1 Serving of broccoli sprouts
3 Servings of broccoli sprouts
Experimental group
Description:
339 grams
Treatment:
Dietary Supplement: 3 Servings of broccoli sprouts

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Kelli Porzondek

Data sourced from clinicaltrials.gov

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