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Recruiting

NCT Number: NCT06784323

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

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.

Recruiting

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Key information

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Up to 8 weeks

    Will be measured with SCCAI.

Secondary outcomes

  1. Fecal calprotectin

    Time frame: Up to 8 weeks

    Change in fecal calprotectin.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

305 243-6405

Oriana Damas, MD, MSCTI

CONTACT

[email protected]

305 243-6405

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jan 20, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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