Sickle Cell, Sickle Cell Disease, Sickle Cell Disease Without Crisis, Mediterranean Diet
Conditions
Keywords
sickle cell, sickle cell disease, sickle cell pain, diet, Mediterranean diet
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.
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).
Interventions
OTHERMediterranean Diet
Mediterranean Diet foods will be provided for 4 weeks.
OTHERUsual Diet
Participants will consume their typical at home-diet.
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. * Pregnancy or breastfeeding * More than 7 in-patient hospital stays in the last year * Currently receiving dialysis treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum and Fecal Short Chain Fatty Acids | Baseline and day 27 or 28 of each diet | Mass spectrometry methods for butyrate, propionate, acetate |
| Serum and Fecal Bile Acid Metabolites | Baseline and day 27 or 28 of each diet | Mass spectrometry methods for primary and secondary bile acid derivatives |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut Microbiota Composition | Baseline and day 27 or 28 of each diet | 16S rRNA amplicon |
| Chronic Pain | 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. |
| Diet adherence | 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. |
Countries
United States
Contacts
CONTACTLisa Tussing-Humphreys, PhD, MS, RD
Outcome results
None listed