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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK140964-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the American diet on disease remission in American patients with Ulcerative Colitis (UC) and to identify biomarkers of response to dietary therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catered diet group | Experimental | Participants will be in this arm for up to 8 weeks. |
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| Diet guidance sessions group | Experimental | Participants will be in this arm for up to 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catered diet | Behavioral | For a period of 8 weeks the participant will receive catered food, the study team will provide the participants breakfast, lunch and dinner. Participants will receive catered food for 3 daily meals, and record daily food intake. Catered diet will be sent to participants' homes on a weekly basis. The diet will consist of primarily whole foods with few additives, with a focus on American staple foods. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response after diet intervention measured by simple clinical colitis activity index (SCCAI) | Will be measured with SCCAI. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal calprotectin | Change in fecal calprotectin. | Up to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oriana Damas, MD, MSCTI | Contact | 305 243-6405 | omazorra@med.miami.edu | |
| Eytan I Stern, MS, RD, LD/N, CNSC | Contact | 305 243-6405 | eis43@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Oriana Damas, MD, MSCTI | University of Miami Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Health System | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Diet guidance sessions | Behavioral | Participants will receive virtual weekly diet guidance with a dietitian regarding food safety preparation methods and cooking practices. Patients will receive weekly gift cards for grocery stipend. On average, initial counseling session with dietitian will last 30 minutes, and 7 follow-up sessions will last 20 minutes. |
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| Dietary counseling | Behavioral | Participants will receive dietary counseling weekly on Zoom for up to 30 minutes. Dietitian will meet with participants to explain benefits of adhering to diet therapy. |
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| Feedback sessions | Behavioral | Participants will be involved in one-time 50-minute feedback session over Zoom with dietitian and principal investigator. During the session, participants will discuss preferred foods/recipes during active disease, likeability of recipes, ease of recipe preparation, dietary adherence, and healthy food affordability. |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |