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

Not Applicable

Completed

• Conditions: Healthy Aging
• Interventions: Other: Cocoa flavanols and berries anthocyanins

• Registration Number: NCT04348162
• Lead Sponsor: National Research Council, Spain

Brief Summary

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

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 Timeline

• Study Start: 2017-09-15
• Study First Submitted: 2020-03-26
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-16
• Primary Completion: 2021-01-01
• Study Completion: 2021-05-15
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cocoa flavanols plus berries anthocyanins	Cocoa flavanols and berries anthocyanins	Cooa and red-berries are taken every day for 10-12 weeks.
Cocoa Flavanols	Cocoa flavanols and berries anthocyanins	Cocoa is taken every day for 10-12 weeks.
Berries anthocyanins	Cocoa flavanols and berries anthocyanins	Red-berries are taken every day for 10-12 weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery	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 Outcome Measures

Name	Time	Method
Change from baseline STROOP score after 10 weeks intervention	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
Change from baseline Tower of London score after 10 weeks intervention	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.

Trial Locations

Locations (1)

Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CISC); 🇪🇸 Madrid, Spain