Tailored Anti-Inflammatory (A-I) Diet for Americans With Ulcerative Colitis (UC)
Not applicable · Testing Catered diet, Diet guidance sessions and Dietary counseling · 1 site · University of Miami
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Catered diet (a behavioral program), Diet guidance sessions (a behavioral program), Dietary counseling (a behavioral program) and Feedback sessions (a behavioral program) as supportive care (to help with symptoms or quality of life). Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 16 to 75
- Any sex
Some of the main requirements, copied from the record:
- Documented diagnosis with ulcerative colitis from medical records.
- Self-Identify as American
- Ages 16-75
Plus 5 more requirement(s). There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 122 participants are expected to take part.
- Start date: 2025-03-05.
- Main results expected around 2030-09-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Clinical response after diet intervention measured by simple clinical colitis activity index (SCCAI) (Up to 8 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | University of Miami |
| Collaborators | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Enrollment | 122 (estimated) |
| Start date | 2025-03-05 |
| Primary completion (est.) | 2030-09-01 |
| First posted | 2025-01-20 |
| Last updated | 2026-03-30 |
| Official title | A Culturally Tailored Anti-inflammatory Diet for American Patients With Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT06784323 |
Interventions
- 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 food… - 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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Health System | Miami, Florida | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.