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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean Diet | Experimental | Commercially prepared foods will be provided. |
|
| Usual Diet | Active Comparator | Consume their typical at-home diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean Diet | Other | Mediterranean Diet foods will be provided for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gut Microbiota Composition | 16S rRNA amplicon | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Tussing-Humphreys, PhD, MS, RD | Contact | 312-355-5521 | tussing@uic.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Usual Diet | Other | Participants will consume their typical at home-diet. |
|
| 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. | 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. | Daily up to 4 weeks during the Mediterranean diet intervention |
| Diet adherence | Skin carotenoid concentration | Baseline and day 27 or 28 of each diet |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |