Sickle Cell, Pain and Mediterranean Diet (MedSCP)

University of Illinois

Status: Begins enrollment this month

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

Treatments: Other: Mediterranean Diet; Other: Usual Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06886477

2025-0041

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Mediterranean Diet

Experimental group

Description:

Commercially prepared foods will be provided.

Treatment:

Other: Usual Diet

Other: Mediterranean Diet

Usual Diet

Active Comparator group

Description:

Consume their typical at-home diet.

Treatment:

Other: Usual Diet

Other: Mediterranean Diet