NCT04348162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

September 16, 2021

Status Verified

April 1, 2020

Enrollment Period

3.3 years

First QC Date

March 26, 2020

Last Update Submit

September 15, 2021

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from baseline STROOP score after 10 weeks intervention

    at inclusion and 10 weeks after intervention

  • Change from baseline Tower of London score after 10 weeks intervention

    at inclusion and 10 weeks after intervention

Study Arms (4)

Cocoa Flavanols

ACTIVE COMPARATOR

Cocoa is taken every day for 10-12 weeks.

Other: Cocoa flavanols and berries anthocyanins

Berries anthocyanins

ACTIVE COMPARATOR

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

Other: Cocoa flavanols and berries anthocyanins

Cocoa flavanols plus berries anthocyanins

ACTIVE COMPARATOR

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

Other: Cocoa flavanols and berries anthocyanins

Control

NO INTERVENTION

Normal diet for 10-12 weeks

Interventions

Cocoa flavanols and berries anthocyaninsOTHER

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

Berries anthocyaninsCocoa FlavanolsCocoa flavanols plus berries anthocyanins

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50-85
  • BMI 20-32 Kg/m2

You may not qualify if:

  • Mini-mental state examination (MMSE) \< 28
  • Systolic blood pressure (SBP) \>139 mmHg
  • Diastolic blood pressure (DBP) \> 89 mmHg
  • Total cholesterol \> 6.5 mmol/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Madrid, 28040, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 26, 2020

First Posted

April 16, 2020

Study Start

September 15, 2017

Primary Completion

January 1, 2021

Study Completion

May 15, 2021

Last Updated

September 16, 2021

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)