atural cocoa consumption in sickle cell disease
Phase 2
- Conditions
- Genetic Diseases
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Participants who are willing to be followed for the 12-week trial period will be included in the study.
Sickle cell patients who are not on any lipid lowering drugs will be included in the RCT.
Exclusion Criteria
Participants on lipid lowering medication prior to phase II will be excluded.
Further, participants with complications (liver/renal conditions) will be excluded due to the high potassium content of cocoa
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main endpoint will be assessed by the mean changes in lipid profile (HDL-cholesterol and triglycerides
- Secondary Outcome Measures
Name Time Method The clinically relevant measures will be BMI, blood pressure, waist circumference, hip circumference, waist-to-hip ratio, fasting blood glucose level, C-reactive protein levels, Interleukin-6, TNF-alpha and oxidative stress biomarkers (SOD, CAT). The differences will be compared between intervention and control groups