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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 16 Years and 75 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Supportive Care
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Catered diet group 		Participants will be in this arm for up to 8 weeks.
  • 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.
Experimental
Diet guidance sessions group 		Participants will be in this arm for up to 8 weeks.
  • 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.

Recruiting Locations

University of Miami Health System
Miami, Florida 33136
Contact:
Niurka Colina, CRC
305 243-6405
nxc610@miami.edu

More Details

Status
Recruiting
Sponsor
University of Miami

Study Contact

Oriana Damas, MD, MSCTI
305 243-6405
omazorra@med.miami.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.