The Vascular and Cognitive Effects of Chronic High-flavanol Intake in Healthy Males

Study Overview
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Brief Summary
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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.

Official Title
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The Vascular and Cognitive Effects of Chronic High-flavanol Intake in Healthy Males

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: High-flavanol milk choocolate
* Dietary Supplement: Low-flavanol milk chocolate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High-flavanol milk chocolate<br>Bi-daily consumption of 12 g portion of a high-flavanol milk chocolate containing approximately 35 mg of (-)-epicatechin for 2-weeks (14 days) | Dietary Supplement: High-flavanol milk choocolate<br> <br> * Other names: Epicatechin-rich milk chocolate;|
| Placebo Comparator: Low-flavanol milk chocolate<br>Bi-daily consumption of 12 g portion of a low-flavanol milk chocolate containing approximately <1 mg of (-)-epicatechin for 2-weeks (14 days) | Dietary Supplement: Low-flavanol milk chocolate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated Dilation (FMD) | Ultrasound-based assessment of brachial artery reactivity following induced reactive hyperemia | Change from baseline at 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure (BP) | Acute assessment of systolic and diastolic BP (3 repeats) | Change from baseline at 14 days | 
| Executive Function | Assessed by cognitive test battery | Change from baseline at 14 days | 
| Endothelial progenitor cells and Microparticles | Flow cytometric analysis using whole blood | Change from baseline at 14 days | 
| Plasma flavanol metabolite analysis | HPLC-MS assessment of metabolite profile and content of plasma | 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 | 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 | Change from baseline at 14 days | 
| Serum analysis of insulin | ELIZA kits for determination of insulin concentration in serum | Change from baseline at 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flow-mediated dilatation (FMD), Vascular function, cognitive function