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

NCT06784323 | Recruiting

• 2 other identifiers: 202408571R01DK140964-01
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Clinical response after diet intervention measured by simple clinical colitis activity index (SCCAI)

  Will be measured with SCCAI.

  Up to 8 weeks

Secondary Outcomes (1)

• Fecal calprotectin

  Up to 8 weeks

Study Arms (2)

Catered diet group

EXPERIMENTAL

Participants will be in this arm for up to 8 weeks.

Behavioral: Catered diet; Behavioral: Diet guidance sessions; Behavioral: Dietary counseling; Behavioral: Feedback sessions

Diet guidance sessions group

EXPERIMENTAL

Participants will be in this arm for up to 8 weeks.

Behavioral: Catered diet; Behavioral: Diet guidance sessions; Behavioral: Dietary counseling; Behavioral: Feedback sessions

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.

Catered diet group; Diet guidance sessions group

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.

Catered diet group; Diet guidance sessions group

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.

Catered diet group; Diet guidance sessions group

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.

Catered diet group; Diet guidance sessions group

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Miami Health System

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Oriana Damas, MD, MSCTI

  University of Miami Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oriana Damas, MD, MSCTI

CONTACT

305 243-6405; omazorra@med.miami.edu

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

CONTACT

305 243-6405; eis43@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)