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

Official title

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

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

Secondary outcome measures (1)

• Fecal calprotectin [Time frame: Up to 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Miami Health System — Miami

Identifiers

NCT: NCT06784323 · 20240857 · 1R01DK140964-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗