Sickle Cell, Pain and Mediterranean Diet (MedSCP)

Exploring the Mediterranean Diet as A Promising Approach for Alleviating Chronic Pain in Sickle Cell Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Sickle Cell Disease; Sickle Cell; Mediterranean Diet; Sickle Cell Disease Without Crisis
• Intervention / Treatment: Other: Mediterranean Diet; Other: 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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Tussing-Humphreys, PhD, MS, RD; Phone Number: 312-355-5521; Email: tussing@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Chicago
      • Contact: Lisa Tussing-Humphreys, PhD, MS, RDN; Phone Number: 312-355-5521; Email: tussing@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
• Pregnancy or breastfeeding
• More than 7 in-patient hospital stays in the last year
• Currently receiving dialysis treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean Diet; Commercially prepared foods will be provided.	Other: Mediterranean Diet; Mediterranean Diet foods will be provided for 4 weeks.; Other: Usual Diet; Participants will consume their typical at home-diet.
Active Comparator: Usual Diet; Consume their typical at-home diet.	Other: Mediterranean Diet; Mediterranean Diet foods will be provided for 4 weeks.; Other: Usual Diet; Participants will consume their typical at home-diet.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut Microbiota Composition	16S rRNA amplicon	Baseline and day 27 or 28 of each diet
Chronic Pain	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.	Baseline and day 27 or 28 of each diet
Diet adherence	Checklist- participants will keep a checklist of foods consumed during the Mediterranean diet intervention period.	Daily up to 4 weeks during the Mediterranean diet intervention
Diet adherence	Photos of uneaten foods will be texted to researchers to see which foods were not consumed.	Daily up to 4 weeks during the Mediterranean diet intervention
Diet adherence	Skin carotenoid concentration	Baseline and day 27 or 28 of each diet

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: diet; sickle cell disease; Mediterranean diet; sickle cell; sickle cell pain
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Anemia, Sickle Cell; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Diet, Mediterranean
• Other Study ID Numbers: 2025-0041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No