NCT06886477

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
May 2025Dec 2026

First Submitted

Initial submission to the registry

March 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 2, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

March 11, 2025

Last Update Submit

April 1, 2026

Conditions

Sickle CellSickle Cell DiseaseSickle Cell Disease Without CrisisMediterranean Diet

Keywords

sickle cellsickle cell diseasesickle cell paindietMediterranean diet

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Gut Microbiota Composition

    Baseline and day 27 or 28 of each diet

  • Chronic Pain

    Baseline and day 27 or 28 of each diet

  • Diet adherence

    Daily up to 4 weeks during the Mediterranean diet intervention

  • Diet adherence

    Daily up to 4 weeks during the Mediterranean diet intervention

  • Diet adherence

    Baseline and day 27 or 28 of each diet

Study Arms (2)

Mediterranean Diet

EXPERIMENTAL

Commercially prepared foods will be provided.

Other: Mediterranean DietOther: Usual Diet

Usual Diet

ACTIVE COMPARATOR

Consume their typical at-home diet.

Other: Mediterranean DietOther: Usual Diet

Interventions

Mediterranean DietOTHER

Mediterranean Diet foods will be provided for 4 weeks.

Mediterranean DietUsual Diet
Usual DietOTHER

Participants will consume their typical at home-diet.

Mediterranean DietUsual Diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Lisa Tussing-Humphreys, PhD, MS, RD

CONTACT

312-355-5521tussing@uic.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 20, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 2, 2026

Record last verified: 2026-04

Locations

US(1)