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

Healthy Aging Clinical Trial

— POLYAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348162
• Other study ID #: AGL2016-76832-R
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: May 15, 2021

Study information

• Verified date: April 2020
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 15, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Aging

Intervention

Other:
• Cocoa flavanols and berries anthocyanins
Effect of cocoa flavanols and berries anthocyanins on cardiovascular and cognitive health

Locations

Country	Name	City	State
Spain	Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CISC)	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
National Research Council, Spain	Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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