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

University of Miami

Status: Enrolling

Conditions: Ulcerative Colitis

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06784323

1R01DK140964-01 (U.S. NIH Grant/Contract)

20240857

Details and patient eligibility

About

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.

Enrollment: 122 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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122 participants in 2 patient groups

Catered diet group

Experimental group

Description:

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

Treatment:

Behavioral: Catered diet

Behavioral: Diet guidance sessions

Behavioral: Dietary counseling

Behavioral: Feedback sessions

Diet guidance sessions group

Experimental group

Description:

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

Treatment:

Behavioral: Catered diet

Behavioral: Diet guidance sessions

Behavioral: Dietary counseling

Behavioral: Feedback sessions