RecruitingNot ApplicableNCT06886477
Sickle Cell, Pain and Mediterranean Diet
Exploring the Mediterranean Diet as A Promising Approach for Alleviating Chronic Pain in Sickle Cell Disease
Sponsor
University of Illinois at Chicago
Enrollment
30 participants
Start Date
May 1, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria9
- 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.
- Pregnancy or breastfeeding
- More than 7 in-patient hospital stays in the last year
- Currently receiving dialysis treatment
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
OTHERMediterranean Diet
Mediterranean Diet foods will be provided for 4 weeks.
OTHERUsual Diet
Participants will consume their typical at home-diet.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06886477
Related Trials
The Efficacy and Safety of Rilzabrutinib in Patients Aged 10 to 65 Years With Sickle-cell Disease
NCT0697586553 locations
A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)
NCT0692497032 locations
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
NCT039378171 location
A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)
NCT0643908230 locations
A Phase 1b, Open-Label Study of DISC-3405 in Participants With Sickle Cell Disease (SCD)
NCT071879733 locations