Skip to main content
OpenTrials
Completed

NCT Number: NCT04348162

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Aging

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CISC)

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cocoa flavanols and berries anthocyanins

Other

Effect of cocoa flavanols and berries anthocyanins on cardiovascular and cognitive health

Primary outcomes

  1. Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery

    Time frame: Over 6 minutes on day 0 and after10 weeks

    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

Secondary outcomes

  1. Change from baseline STROOP score after 10 weeks intervention

    Time frame: at inclusion and 10 weeks after 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

  2. Change from baseline Tower of London score after 10 weeks intervention

    Time frame: at inclusion and 10 weeks after 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.

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • Hospital Universitario 12 de Octubre

Registry information

Acronym: POLYAGE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 16, 2020
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.