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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06784323
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 5, 2025
Status verified
Mar 2026
Primary completion
Sep 1, 2030
Completion
Sep 1, 2030

Study Design

Enrollment
122 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Catered diet group
    Participants will be in this arm for up to 8 weeks.
  • Experimental: Diet guidance sessions group
    Participants will be in this arm for up to 8 weeks.

Primary Outcome Measure

Clinical response after diet intervention measured by simple clinical colitis activity index (SCCAI) [ Time Frame: Up to 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami Health SystemMiamiFlorida33136
Niurka Colina, CRC
[email protected]
305 243-6405
Michael Mijares
[email protected]
305 243-6405
Oriana Damas, MD, MSCTI (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
University of Miami Health System· Miami, FL

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