Sickle Cell, Pain and Mediterranean Diet

Not Applicable

Not yet recruiting

• Conditions: Sickle Cell; Mediterranean Diet; Sickle Cell Disease; Sickle Cell Disease Without Crisis

• Registration Number: NCT06886477
• Lead Sponsor: University of Illinois at Chicago

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 recruited, with an estimated 24 participants completing the study).

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-27
• Study Start: 2025-05-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Serum and Fecal Short Chain Fatty Acids	Baseline and day 27 or 28 of each diet	Mass spectrometry methods for butyrate, propionate, acetate
Serum and Fecal Bile Acid Metabolites	Baseline and day 27 or 28 of each diet	Mass spectrometry methods for primary and secondary bile acid derivatives

Secondary Outcome Measures

Name	Time	Method
Gut Microbiota Composition	Baseline and day 27 or 28 of each diet	16S rRNA amplicon
Chronic Pain	Baseline and day 27 or 28 of each diet	Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Survey will be used to measure the experience of chronic pain on a 1-10 scale. The higher the number, the greater the chronic pain experience.
Diet adherence	Baseline and day 27 or 28 of each diet	Skin carotenoid concentration