Food Anthocyanins and Flavanols as a Strategy for a Healthy Ageing: Cardiovascular Health and Cognitive Performance

Study Overview
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Brief Summary
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The study examines the effect of cocoa flavanols, red-berries anthocyanins or a combination of both on markers of cardiovascular health and cognition.

Detailed Description
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The study examines the effect of cocoa flavanols, red-berries anthocyanins or a combination of both on markers of cardiovascular health and cognition. Healthy volunteers are recruited to participate in a parallel study (n 30 per group) for 10 to 12 weeks. Markers of cardiovascular health (FMD, markers of inflammation and fatty acid metabolism) and cognition (neuropsychological tests and plasma neurotrophins) are being measured before and after intervention.

Official Title
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Food Anthocyanins and Flavanols as a Strategy for a Healthy Ageing: Cardiovascular Health and Cognitive Performance

Conditions
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Healthy Aging

Intervention / Treatment
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* Other: Cocoa flavanols and berries anthocyanins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50-85 BMI 20-32 Kg/m2 Exclusion Criteria: Mini-mental state examination (MMSE) < 28 Systolic blood pressure (SBP) >139 mmHg Diastolic blood pressure (DBP) > 89 mmHg Total cholesterol > 6.5 mmol/L

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

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: Cocoa Flavanols<br>Cocoa is taken every day for 10-12 weeks. | Other: Cocoa flavanols and berries anthocyanins<br>* Effect of cocoa flavanols and berries anthocyanins on cardiovascular and cognitive health<br>|
| Active Comparator: Berries anthocyanins<br>Red-berries are taken every day for 10-12 weeks. | Other: Cocoa flavanols and berries anthocyanins<br>* Effect of cocoa flavanols and berries anthocyanins on cardiovascular and cognitive health<br>|
| Active Comparator: Cocoa flavanols plus berries anthocyanins<br>Cooa and red-berries are taken every day for 10-12 weeks. | Other: Cocoa flavanols and berries anthocyanins<br>* Effect of cocoa flavanols and berries anthocyanins on cardiovascular and cognitive health<br>|
| No Intervention: Control<br>Normal diet for 10-12 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery | The FMD of the brachial artery will be measured using an ultrasound collected at baseline and continuously for 60 seconds post-arm occlusion for 5 minutes. FMD will be expressed as percentage of variation between pre-and postischemic diameters | Over 6 minutes on day 0 and after10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline STROOP score after 10 weeks intervention | STROOP tests attention and executive function. This test aims to evaluate the inhibition of an automated process such as reading by asking participants to name the color of color names written in a different color ink. For each participant SROOP results at inclusion will be compared with results after 10 weeks intervention | at inclusion and 10 weeks after intervention | 
| Change from baseline Tower of London score after 10 weeks intervention | Tower of London test consist of a three color game board that allows executive functioning evaluation by total time, time to first move and optimal moves change from participants inclusion to week 11. | at inclusion and 10 weeks after intervention |