Status:
RECRUITING
Sickle Cell, Pain and Mediterranean Diet
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Sickle Cell
Sickle Cell Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this study is to compare pain levels in individuals with Sickle Cell Disease while following the Mediterranean Diet to pain levels while following their usual diet.
Detailed Description
This is an exploratory, randomized, crossover-controlled feeding study of a 4-week Mediterranean Diet or usual diet control among 24 adults with sickle cell disease and chronic pain (30 will be recrui...
Eligibility Criteria
Inclusion
- Sickle Cell Disease Diagnosis
- Chronic non-vaso-occlusive pain experienced on average ≥ 3 days per week for \> 6 months (based on a response of "Most days," "Every day," or "Some days" and not "Never" to the question "In the past 6 months, how often have you had pain?")
- Ability to speak, read, write, and understand English
- A Mediterranean Eating Pattern for Americans (MEPA-III) score \<13, indicating that they do not follow a Mediterranean diet.
Exclusion
- Having taken systemic antimicrobials (to treat an infection in the previous 4 weeks)
- History of colon cancer or inflammatory bowel disease (given potential untoward effects on the gut microbiome)
- History of Clostridium difficile infection in the preceding 12 weeks; (4) unable to agree to maintain physical activity at the current level for the duration of the study
- Currently following a Mediterranean diet, vegan diet, or dietary restrictions (e.g., religious, food intolerance/allergy) that preclude adoption of a Mediterranean diet
- Lack of access to a space to safely store and reheat food items
- Living in a facility that provides meals.
Key Trial Info
Start Date :
July 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06886477
Start Date
July 28 2025
End Date
December 1 2026
Last Update
July 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Illinois Chicago
Chicago, Illinois, United States, 60612