Recruiting

A-I Diet

Sponsor:

University of Miami

Code:

NCT06784323

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

Catered diet

Diet guidance sessions

Dietary counseling

Feedback sessions

Study Details

Brief 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

Study ID

NCT06784323

Start date

Mar 5, 2025

Status verified date

Mar, 2026

Completion date

Sep 1, 2030

Anticipated

Primary completion date

Sep 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Documented diagnosis with ulcerative colitis from medical records.
  • Self-Identify as American
  • Ages 16-75
  • SCCAI between 3-9 (no greater than 12 bowel movements a day)
  • Fecal calprotectin > 150mg/dl.
  • On stable medications for their disease for the past 3 months
  • Likeability of American foods (sandwiches, BBQ or grilled meats and vegetables, baked potatoes, smoothies, salmon, oatmeal, avocado, soups)
  • No recent Inflammatory Bowel Disease (IBD) related hospitalization in the last month.

Exclusion Criteria:

  • Diagnosis of Crohn's Disease (CD).
  • Prior ileoanal anastomosis (J-pouch) or diversion
  • No recent hospitalizations on the last 4 weeks
  • No Clostridium difficile or enteric infections on the last 4 weeks
  • No use of probiotics on the last 4 weeks
  • Patients following the specific carbohydrate diet or mediterranean diet or anti-inflammatory diet
  • No active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)
  • Pregnancy, breastfeeding or planning to become pregnant during study period
  • Use of Total Parenteral Nutrition at the time of screening and during the study period
  • Other significant or life-threatening co-morbidities
  • The need for antibiotic use during the study period
  • Adults unable to consent
  • Ages less than 16 and > 75 years old
  • Prisoners

Study Design

Enrollment

122 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

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.

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Oriana Damas, MD, MSCTI

305 243-6405omazorra@med.miami.edu

Eytan I Stern, MS, RD, LD/N, CNSC

305 243-6405eis43@miami.edu

Locations

University of Miami Health System

Recruiting

Miami, Florida, United States, 33136

Contacts

Niurka Colina, CRC

305 243-6405nxc610@miami.edu

Michael Mijares

305 243-6405mmijares74@med.miami.edu

Principal Investigator:

Oriana Damas, MD, MSCTI

More Information

Sponsor

University of Miami

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-30.