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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Behavioral: Diet guidance sessions; Behavioral: Dietary counseling; Behavioral: Feedback sessions; Behavioral: Catered diet

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oriana Damas, MD, MSCTI; Phone Number: 305 243-6405; Email: omazorra@med.miami.edu
• Study Contact Backup: Name: Eytan I Stern, MS, RD, LD/N, CNSC; Phone Number: 305 243-6405; Email: eis43@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Health System
      • Contact: Michael Mijares; Phone Number: 305 243-6405; Email: mmijares74@med.miami.edu
      • Principal Investigator: Oriana Damas, MD, MSCTI
      • Contact: Niurka Colina, CRC; Phone Number: 305 243-6405; Email: nxc610@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catered diet group; Participants will be in this arm for up to 8 weeks.	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.; 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.
Experimental: Diet guidance sessions group; Participants will be in this arm for up to 8 weeks.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal calprotectin	Change in fecal calprotectin.	Up to 8 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Oriana Damas, MD, MSCTI, University of Miami Health System

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Measurements; Nutrition Assessment
• Other Study ID Numbers: 20240857; 1R01DK140964-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No