Healthy
Conditions
Keywords
Flow-mediated dilatation (FMD), Vascular function, cognitive function
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTHigh-flavanol milk choocolate
DIETARY_SUPPLEMENTLow-flavanol milk chocolate
Sponsors
University of Reading
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index 18.5-27.5 kg/m2 * Normal Blood pressure (\< 150/90) * Non-smoker * Regular exercise routine * Signed consent form
Exclusion criteria
* Haemoglobin (anaemia marker) \< 125 g/l * Gamma GT (liver enzymes) \> 80 IU/l * Total Cholesterol \> 6.5 mmol/l * Suffered a myocardial infarction or stroke in the last 12 months * Suffers from any cardiovascular or metabolic disorders * Suffers from any blood-clotting disorder, and/or takes supporting medication * Any dietary restrictions or on a weight reducing diet * On any lipid-modifying or blood pressure lowering medication * Consuming any specific vitamin/ herbal supplements or fish oils
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow-mediated Dilation (FMD) | Change from baseline at 14 days | Ultrasound-based assessment of brachial artery reactivity following induced reactive hyperemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma flavanol metabolite analysis | Change from baseline at 14 days | HPLC-MS assessment of metabolite profile and content of plasma |
| Plasma Nitrite & Nitrate analysis | Change from baseline at 14 days | HPLC-based system with inbuilt colorimetric Griess reaction assay for the assessment of Nitrite & Nitrate in plasma |
| Blood pressure (BP) | Change from baseline at 14 days | Acute assessment of systolic and diastolic BP (3 repeats) |
| Serum analysis of cardivascular-related blood marker(s) concentration | Change from baseline at 14 days | ILAB assessment of serum content of glucose, Triglycerides, total cholesterol, HDL-cholesterol, C-reactive protein and Non-esterified fatty acids |
| Endothelial progenitor cells and Microparticles | Change from baseline at 14 days | Flow cytometric analysis using whole blood |
| Serum analysis of insulin | Change from baseline at 14 days | ELIZA kits for determination of insulin concentration in serum |
| Executive Function | Change from baseline at 14 days | Assessed by cognitive test battery |
Outcome results
None listed