NCT06784323

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BEHAVIORAL	Catered 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.
BEHAVIORAL	Diet 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.
BEHAVIORAL	Dietary 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.
BEHAVIORAL	Feedback 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.

Timeline

• Start date: 2025-03-05
• Primary completion: 2030-09-01
• Completion: 2030-09-01
• First posted: 2025-01-20
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States