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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-67017-36303 | Other Grant/Funding Number | USDA National Institute of Food and Agriculture (NIFA) |
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| Name | Class |
|---|---|
| University of Maine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Serving of broccoli sprouts | Experimental | 113 grams |
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| 3 Servings of broccoli sprouts | Experimental | 339 grams |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 Serving of broccoli sprouts | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
| 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. | Day 28 |
| Levels of sulforaphane in the stool | Level recorded in micrograms/gram. | Day 28 |
| Levels of sulforaphane in the blood | Level recorded in micrograms/gram. | Day 28 |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Grace Chen | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2024 | Jan 21, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 3 Servings of broccoli sprouts | Dietary Supplement | 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. |
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| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |