Actively Recruiting
Exploring the Mediterranean Diet as A Promising Approach for Alleviating Chronic Pain in Sickle Cell Disease
Led by University of Illinois at Chicago · Updated on 2026-04-02
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how the Mediterranean Diet affects pain levels in adults with Sickle Cell Disease who experience chronic pain. This exploratory, randomized, crossover-controlled study involves 24 adults and aims to compare pain while following the Mediterranean Diet versus their usual diet. The study is led by the University of Illinois at Chicago and focuses on chronic non-vaso-occlusive pain in this population. Participants will follow two diet periods: one with provided Mediterranean Diet meals for 4 weeks and another consuming their usual at-home diet. The study design is crossover, meaning each participant will experience both diets in random order. Commercially prepared Mediterranean Diet foods will be supplied, while the usual diet period involves participants eating their typical meals at home. During the study, researchers will measure serum and fecal short chain fatty acids and bile acid metabolites at baseline and after each diet period (day 27 or 28). They will also assess gut microbiota composition, chronic pain levels, and diet adherence daily throughout the Mediterranean Diet intervention. Participants will be monitored closely for diet adherence and pain changes during the study period, which begins in May 2025 and ends December 2026.
CONDITIONS
Brief Title
Sickle Cell, Pain and Mediterranean Diet
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Sickle Cell Disease
- Chronic non-vaso-occlusive pain experienced on average 3 or more days per week for over 6 months
- Ability to speak, read, write, and understand English
- Mediterranean Eating Pattern for Americans (MEPA-III) score below 13, indicating low adherence to Mediterranean diet
You will not qualify if you...
- Use of systemic antimicrobials in the past 4 weeks
- History of colon cancer or inflammatory bowel disease
- History of Clostridium difficile infection within the past 12 weeks
- Inability to maintain current physical activity level during the study
- Currently following a Mediterranean diet, vegan diet, or having dietary restrictions preventing Mediterranean diet adoption
- Lack of access to safe food storage and reheating space
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 weeks total (4 weeks per diet)
Participants will follow either a Mediterranean Diet provided for 4 weeks or continue their usual diet, then cross over to the other diet for another 4 weeks.
Multiple visits including baseline and end of each diet period
Trial Site Locations
Total: 1 location
1
University of Illinois Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
L
Lisa Tussing-Humphreys, PhD, MS, RD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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