Ulcerative Colitis
Conditions
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.
Interventions
BEHAVIORALCatered 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.
BEHAVIORALDiet 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.
BEHAVIORALDietary 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.
BEHAVIORALFeedback 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.
Sponsors
University of Miami
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response after diet intervention measured by simple clinical colitis activity index (SCCAI) | Up to 8 weeks | Will be measured with SCCAI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal calprotectin | Up to 8 weeks | Change in fecal calprotectin. |
Countries
United States
Contacts
CONTACTOriana Damas, MD, MSCTI
CONTACTEytan I Stern, MS, RD, LD/N, CNSC
PRINCIPAL_INVESTIGATOROriana Damas, MD, MSCTI
University of Miami Health System
Outcome results
None listed