Anti-Inflammatory Diet for Ulcerative Colitis

Overseen By Eytan I Stern, MS, RD, LD/N, CNSC

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

122 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the Hispanics/Latino (H/L) diet on disease remission in H/L patients with Ulcerative Colitis (UC) and to identify biomarkers of response to dietary therapy.

Research Team

Oriana Damas, MD, MSCTI

Principal Investigator

University of Miami Health System

Eligibility Criteria

This trial is for Hispanic/Latino individuals with Ulcerative Colitis (UC). Participants should be interested in following a tailored anti-inflammatory diet that includes native Hispanic foods. Specific eligibility criteria are not provided, but typically include factors like age, disease severity, and willingness to adhere to the study's dietary requirements.

Inclusion Criteria

Self-Identify as Hispanic/Latino

Documented diagnosis with ulcerative colitis from medical records

SCCAI between 3-9 (no greater than 12 bowel movements a day)

Exclusion Criteria

I have had surgery to create a J-pouch or a diversion.

I have been diagnosed with Crohn's Disease.

Patients following the specific carbohydrate diet or Mediterranean diet or anti-inflammatory diet

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow an anti-inflammatory diet incorporating native foods of the Hispanic/Latino diet for up to 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tailored Anti-Inflammatory (A-I) Diet

Trial Overview The study tests an anti-inflammatory diet tailored for Hispanics/Latinos with UC. It involves diet guidance sessions, feedback meetings, a catered diet based on native foods, and dietary counseling to see if this can help achieve disease remission and identify biomarkers of response.

Participant Groups

Group I: Diet guidance sessions group Experimental Treatment 4 Interventions

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

Group II: Catered diet group Experimental Treatment 4 Interventions

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

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+