University of Miami Health System
Miami, Florida, 33136, United States
Location status: Recruiting
Location contact
Michael Mijares
CONTACT
Niurka Colina, CRC
CONTACT
Oriana Damas, MD, MSCTI
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06784323
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.
Interested in participating?
Request Info16 year–75 year
All sexes
Interventional
Not applicable
Miami, Florida, 33136, United States
Location status: Recruiting
Michael Mijares
CONTACT
Niurka Colina, CRC
CONTACT
Oriana Damas, MD, MSCTI
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Up to 8 weeks
Will be measured with SCCAI.
Time frame: Up to 8 weeks
Change in fecal calprotectin.
Contact information is provided by the study sponsor or research team.
Eytan I Stern, MS, RD, LD/N, CNSC
CONTACT
Oriana Damas, MD, MSCTI
CONTACT
University of Miami
Other
A Culturally Tailored Anti-inflammatory Diet for American Patients With Ulcerative Colitis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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