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

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

Study Overview

• Status: Completed
• Conditions: Healthy Aging
• Intervention / Treatment: Other: Cocoa flavanols and berries anthocyanins

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CISC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Cocoa Flavanols; Cocoa is taken every day for 10-12 weeks.	Other: Cocoa flavanols and berries anthocyanins; Effect of cocoa flavanols and berries anthocyanins on cardiovascular and cognitive health
ACTIVE_COMPARATOR: Berries anthocyanins; Red-berries are taken every day for 10-12 weeks.	Other: Cocoa flavanols and berries anthocyanins; Effect of cocoa flavanols and berries anthocyanins on cardiovascular and cognitive health
ACTIVE_COMPARATOR: Cocoa flavanols plus berries anthocyanins; Cooa and red-berries are taken every day for 10-12 weeks.	Other: Cocoa flavanols and berries anthocyanins; Effect of cocoa flavanols and berries anthocyanins on cardiovascular and cognitive health
NO_INTERVENTION: Control; Normal diet for 10-12 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Research Council, Spain
• Collaborators: Hospital Universitario 12 de Octubre

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2017
• Primary Completion (ACTUAL): January 1, 2021
• Study Completion (ACTUAL): May 15, 2021

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (ACTUAL): April 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AGL2016-76832-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No