Mediterranean diet to reduce chronic pain in sickle cell disease

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

This study will test whether following a Mediterranean diet for four weeks reduces chronic pain in adults with sickle cell disease compared with their usual diet.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Illinois at Chicago (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06886477 on ClinicalTrials.gov

What this trial studies

This is a randomized, crossover-controlled feeding study in which adults with sickle cell disease and chronic non-vaso-occlusive pain will follow a 4-week Mediterranean diet and a 4-week usual diet control in randomized order. Meals will be provided during each diet period to standardize intake, and participants serve as their own controls. The trial plans to recruit 30 participants to obtain an estimated 24 completers. Pain levels and related outcomes will be compared between the Mediterranean and usual diet periods.

Who should consider this trial

Good fit: Adults with a confirmed diagnosis of sickle cell disease who report chronic non-vaso-occlusive pain on average at least 3 days per week for more than 6 months, speak English, and currently do not follow a Mediterranean eating pattern (MEPA-III score <13) are ideal candidates.

Not a fit: People currently following a Mediterranean or vegan diet, those with recent systemic antibiotic use, or those with gastrointestinal conditions like inflammatory bowel disease or recent C. difficile infection are unlikely to benefit or are excluded from participation.

Why it matters

Potential benefit: If successful, adopting a Mediterranean diet could lower the frequency or intensity of chronic pain for adults with sickle cell disease.

How similar studies have performed: Mediterranean dietary patterns have reduced inflammation and pain in other chronic conditions, but this approach is only minimally tested specifically for chronic pain in sickle cell disease.

Eligibility criteria

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

Where this trial is running

Chicago, Illinois

• University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Lisa Tussing-Humphreys, PhD, MS, RD

Conditions Sickle Cell; Sickle Cell Disease; Sickle Cell Disease Without Crisis; Mediterranean Diet; sickle cell; sickle cell disease; sickle cell pain; diet