Sickle Cell, Pain and Mediterranean Diet
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Mediterranean Diet
Other interventionMediterranean Diet foods will be provided for 4 weeks.
Usual Diet
Other interventionParticipants will consume their typical at home-diet.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Mediterranean DietExperimental treatment 2 interventions
Group B: Usual DietActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Serum and Fecal Short Chain Fatty Acids
Mass spectrometry methods for butyrate, propionate, acetate
Time frame
Baseline and day 27 or 28 of each diet2
Serum and Fecal Bile Acid Metabolites
Mass spectrometry methods for primary and secondary bile acid derivatives
Time frame
Baseline and day 27 or 28 of each dietSecondary outcomes
1
Gut Microbiota Composition
16S rRNA amplicon
Time frame
Baseline and day 27 or 28 of each diet2
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.
Time frame
Baseline and day 27 or 28 of each diet3
Diet adherence
Checklist- participants will keep a checklist of foods consumed during the Mediterranean diet intervention period.
Time frame
Daily up to 4 weeks during the Mediterranean diet intervention4
Diet adherence
Photos of uneaten foods will be texted to researchers to see which foods were not consumed.
Time frame
Daily up to 4 weeks during the Mediterranean diet interventionSponsors and contacts
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Source ClinicalTrials.gov