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

NCT ID: NCT04348162

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2021-05-15

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.

Conditions

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Healthy Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Cocoa Flavanols

Cocoa is taken every day for 10-12 weeks.

Group Type ACTIVE_COMPARATOR

Cocoa flavanols and berries anthocyanins

Intervention Type OTHER

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

Berries anthocyanins

Red-berries are taken every day for 10-12 weeks.

Group Type ACTIVE_COMPARATOR

Cocoa flavanols and berries anthocyanins

Intervention Type OTHER

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

Cocoa flavanols plus berries anthocyanins

Cooa and red-berries are taken every day for 10-12 weeks.

Group Type ACTIVE_COMPARATOR

Cocoa flavanols and berries anthocyanins

Intervention Type OTHER

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

Control

Normal diet for 10-12 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cocoa flavanols and berries anthocyanins

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

Intervention Type OTHER

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario 12 de Octubre

OTHER

Sponsor Role collaborator

National Research Council, Spain

OTHER_GOV

Sponsor Role lead

Responsible Party

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Spanish National Research Council

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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AGL2016-76832-R

Identifier Type: -

Identifier Source: org_study_id

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