Sickle CellMedSCPNCT06886477
Sickle Cell, Pain and Mediterranean Diet
A study testing Mediterranean Diet and Usual Diet in people with Sickle Cell and Sickle Cell Disease, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell, Sickle Cell Disease, Sickle Cell Disease Without Crisis
- What is being tested?
- Mediterranean Diet and Usual Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 9 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60612
About this study
Official title: 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.
Read the 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).
- Being tested
- Mediterranean Diet, Usual Diet
- Keywords
- sickle cell, sickle cell disease, sickle cell pain, diet, Mediterranean diet
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietOther
Mediterranean Diet foods will be provided for 4 weeks.
Usual DietOther
Participants will consume their typical at home-diet.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet | Experimental | Commercially prepared foods will be provided. Receives: Other: Mediterranean Diet; Other: Usual Diet |
| Usual Diet | Active comparator | Consume their typical at-home diet. Receives: Other: Mediterranean Diet; Other: Usual Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum and Fecal Short Chain Fatty Acids
Mass spectrometry methods for butyrate, propionate, acetate
Measured: 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
Measured: Baseline and day 27 or 28 of each diet
Secondary outcomes (5)
Gut Microbiota Composition
16S rRNA amplicon
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily up to 4 weeks during the Mediterranean diet intervention
Diet adherence
Skin carotenoid concentration
Measured: Baseline and day 27 or 28 of each diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 May 2025
- Primary completion9 Jul 2026
- Study completion9 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle CellStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886477
- Sponsor's protocol ID
- 2025-0041
- Acronym
- MedSCP
- Status last verified
- Jul 2026
- First submitted
- 11 Mar 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Mediterranean Diet as A Promising Approach for Alleviating Chronic Pain in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06886477
- Acronym / sponsor ID
- MedSCP / 2025-0041
- Keywords
- sickle cell, sickle cell disease, sickle cell pain, diet, Mediterranean diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet | Experimental | Other: Mediterranean Diet, Other: Usual DietCommercially prepared foods will be provided. |
| Usual Diet | Active comparator | Other: Mediterranean Diet, Other: Usual DietConsume their typical at-home diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean DietMediterranean Diet foods will be provided for 4 weeks. | Other | Mediterranean Diet, Usual Diet |
| Usual DietParticipants will consume their typical at home-diet. | Other | Mediterranean Diet, Usual Diet |
Primary outcome
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
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
5 secondary outcomes
Gut Microbiota Composition
Time frame: Baseline and day 27 or 28 of each diet
Chronic Pain
Time frame: Baseline and day 27 or 28 of each diet
Diet adherence
Time frame: Daily up to 4 weeks during the Mediterranean diet intervention
Diet adherence
Time frame: Daily up to 4 weeks during the Mediterranean diet intervention
Diet adherence
Time frame: Baseline and day 27 or 28 of each diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Sickle Cell
Not yet recruitingPhase 1
Minocycline In Neurocognitive Outcomes - Sickle Cell Disease
Sickle Cell Disease, Cognitive Impairment
RecruitingPhase 2
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Sickle Cell Disease
Not yet recruitingObservational study
Data Collection For Patients With Sickle Cell Disease
Data Collection, Sickle Cell Disease
Not yet recruiting
Hypoxic Red Blood Cells in Sickle Cell Anemia
Sickle Cell Anaemia, Sickle Cell Anemia Crisis
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet and Usual Diet in people with Sickle Cell and Sickle Cell Disease, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum and Fecal Short Chain Fatty Acids (time frame: Baseline and day 27 or 28 of each diet). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.