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Cruciferous Vegetables
Broccoli Sprouts for Ulcerative Colitis
N/A
Recruiting
Led By Grace Chen
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if eating broccoli sprouts can help patients with mild ulcerative colitis by increasing a compound called sulforaphane in their bodies, which may reduce inflammation. Sulforaphane (SFN), an isothiocyanate present in cruciferous vegetables such as broccoli and brussels sprouts, has a variety of biological functions.
Who is the study for?
This trial is for adults with mild ulcerative colitis, who are on a stable dose of certain medications like Aminosalicylic acids or Imuran. Participants should have a BMI between 18.5-40 and not be consuming more than 5 ½ cups of fruits and vegetables daily. They must understand the study and consent to it.
What is being tested?
The study tests if eating either one or three servings of broccoli sprouts can increase sulforaphane levels in the body and decrease inflammation markers in patients with mild ulcerative colitis, as preparation for a larger future trial.
What are the potential side effects?
While specific side effects aren't listed, participants may experience changes related to their digestive system due to increased intake of broccoli sprouts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of adopting a steamed broccoli diet in patients with inflammatory bowel disease ulcerative colitis as measured by participant compliance.
Ulcerative Colitis
Levels of sulforaphane in the blood
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: 3 Servings of broccoli sproutsExperimental Treatment1 Intervention
339 grams
Group II: 1 Serving of broccoli sproutsExperimental Treatment1 Intervention
113 grams
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Ulcerative Colitis (UC) include anti-inflammatory agents such as 5-aminosalicylic acid (5-ASA) and corticosteroids, which reduce inflammation in the colon by inhibiting the production of inflammatory cytokines. Immunosuppressants like azathioprine and biologics such as TNF inhibitors work by dampening the immune response that drives inflammation.
Dietary interventions, including the use of natural compounds like sulforaphane found in broccoli sprouts, aim to reduce inflammation by enhancing the body's antioxidant defenses and modulating inflammatory pathways. These treatments are crucial for UC patients as they help manage symptoms, maintain remission, and improve quality of life by targeting the underlying inflammatory processes.
Probiotics for induction of remission in ulcerative colitis.
Probiotics for induction of remission in ulcerative colitis.
Find a Location
Who is running the clinical trial?
University of MaineOTHER
3 Previous Clinical Trials
6,665 Total Patients Enrolled
University of MichiganLead Sponsor
1,855 Previous Clinical Trials
6,435,021 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
68 Patients Enrolled for Ulcerative Colitis
Grace ChenPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking NSAIDs or biologic/immunomodulatory therapies.My ulcerative colitis is mild, confirmed by tests.I have not taken antibiotics in the last 2 weeks.I am not on IV nutrition or tube feeding.I am on a special diet, TPN, or tube feeds as prescribed by my doctor.I am on a stable dose of specific medications for my condition.I understand and agree to the study's procedures.I was recently diagnosed with diabetes or heart disease, or it is not well-controlled.
Research Study Groups:
This trial has the following groups:- Group 1: 1 Serving of broccoli sprouts
- Group 2: 3 Servings of broccoli sprouts
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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