RecruitingNot ApplicableNCT06784323

Tailored Anti-Inflammatory (A-I) Diet for Americans With Ulcerative Colitis (UC)

A Culturally Tailored Anti-inflammatory Diet for American Patients With Ulcerative Colitis


Sponsor

University of Miami

Enrollment

122 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 16 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an anti-inflammatory diet tailored to American food preferences for people with ulcerative colitis (UC), a type of inflammatory bowel disease. Researchers want to see if this diet can reduce inflammation and improve symptoms. **You may be eligible if...** - You are between 16 and 75 years old - You have a confirmed diagnosis of ulcerative colitis - You self-identify as American - Your UC is moderately active (no more than 12 bowel movements per day) - You have been on stable medication for your UC for at least 3 months - You enjoy common American foods like sandwiches, grilled meats, smoothies, or oatmeal **You may NOT be eligible if...** - You have been hospitalized for UC recently - Your disease is in remission or severely out of control - You do not like the recommended foods in the study diet Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCatered diet

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.

BEHAVIORALDiet guidance sessions

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.

BEHAVIORALDietary counseling

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.

BEHAVIORALFeedback sessions

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.


Locations(1)

University of Miami Health System

Miami, Florida, United States

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NCT06784323


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