A randomised, placebo-controlled, parallel human dietary intervention trial conducted in 33 healthy males to investigate the vascular and cognitive effects of bi-daily consumption of high-flavanol (epicatechin-rich) milk chocolate over a 2-week intervention period. Subjects visited the Hugh Sinclair Unit of Human Nutrition on 3 separate occasions; at the beginning, end and post-intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
34
Flow-mediated Dilation (FMD)
Ultrasound-based assessment of brachial artery reactivity following induced reactive hyperemia
Time frame: Change from baseline at 14 days
Blood pressure (BP)
Acute assessment of systolic and diastolic BP (3 repeats)
Time frame: Change from baseline at 14 days
Executive Function
Assessed by cognitive test battery
Time frame: Change from baseline at 14 days
Endothelial progenitor cells and Microparticles
Flow cytometric analysis using whole blood
Time frame: Change from baseline at 14 days
Plasma flavanol metabolite analysis
HPLC-MS assessment of metabolite profile and content of plasma
Time frame: Change from baseline at 14 days
Plasma Nitrite & Nitrate analysis
HPLC-based system with inbuilt colorimetric Griess reaction assay for the assessment of Nitrite \& Nitrate in plasma
Time frame: Change from baseline at 14 days
Serum analysis of cardivascular-related blood marker(s) concentration
ILAB assessment of serum content of glucose, Triglycerides, total cholesterol, HDL-cholesterol, C-reactive protein and Non-esterified fatty acids
Time frame: Change from baseline at 14 days
Serum analysis of insulin
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ELIZA kits for determination of insulin concentration in serum
Time frame: Change from baseline at 14 days