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Completed

NCT Number: NCT06886477

Sickle Cell, Pain and Mediterranean Diet

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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

Treatment and study plan

Mediterranean Diet

Other

Mediterranean Diet foods will be provided for 4 weeks.

Usual diet

Other

Participants will consume their typical at home-diet.

Primary outcomes

  1. Serum and Fecal Short Chain Fatty Acids

    Time frame: Baseline and day 27 or 28 of each diet

    Mass spectrometry methods for butyrate, propionate, acetate

  2. Serum and Fecal Bile Acid Metabolites

    Time frame: Baseline and day 27 or 28 of each diet

    Mass spectrometry methods for primary and secondary bile acid derivatives

Secondary outcomes

  1. Gut Microbiota Composition

    Time frame: Baseline and day 27 or 28 of each diet

    16S rRNA amplicon

  2. Chronic Pain

    Time frame: 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.

  3. Diet adherence

    Time frame: Daily up to 4 weeks during the Mediterranean diet intervention

    Checklist- participants will keep a checklist of foods consumed during the Mediterranean diet intervention period.

  4. Diet adherence

    Time frame: Daily up to 4 weeks during the Mediterranean diet intervention

    Photos of uneaten foods will be texted to researchers to see which foods were not consumed.

  5. Diet adherence

    Time frame: Baseline and day 27 or 28 of each diet

    Skin carotenoid concentration

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

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

Acronym: MedSCP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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