The Acute Effects of Cocoa Flavanols Intake on Overt and Covert Attention

February 13, 2025 updated by: Oğuz Karataş, Konya Necmettin Erbakan Üniversitesi

The Acute Effects of Cocoa Flavanols Intake on Overt and Covert Attention: a Randomized, Double-blind Crossover Trial

The present study aimed to examine whether a cocoa beverage containing 710 mg of flavanols enhances both overt and covert attention in healthy young adults, using a randomized, double-blind, baseline- and placebo-controlled crossover design.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cocoa flavanols (CF) have various physiological effects that may directly or indirectly enhance cognitive functions. Following CF intake, a series of biochemical processes within vascular smooth muscle cells lead to the relaxation of smooth muscles, the dilation of blood vessels, and an increase in cerebral blood flow. For the brain to function optimally, cerebral blood flow must be maintained at a level that ensures a constant supply of oxygen and glucose to neurons. During periods of intense neuronal activity, neurons require more oxygen and nutrients, which is met by an increase in blood flow. Given that CF has been shown to enhance blood flow and perfusion in brain regions associated with attention (e.g., the parietal cortex, anterior cingulate cortex, and dorsolateral prefrontal cortex), it was hypothesized that CF intake could acutely improve both overt and covert attention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42090
        • Konya Necmettin Erbakan University Cognitive Psychology Laboratuary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Normal or corrected-to-normal visual acuity

Exclusion Criteria:

  • History of neurological, psychiatric, cardiovascular or metabolic disorders
  • Following a medically restricted diet
  • Taking antidepressant, anxiolytic, and antipsychotic drugs in the past three months
  • Currently taking anticoagulant
  • Taking herbal supplements in the past week
  • Allergic or intolerant to cocoa, caffeine, sucrose, or fructose
  • Color blindness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Baseline/Placebo/Flavanol
Participants consumed sugar water, an alkalized cocoa beverage, and a natural cocoa beverage containing 710 mg of flavanols, with a one-week washout period between interventions.
Dietary supplement: Flavanol
Natural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Dietary supplement: Placebo
Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Other: Sugar water
250 mL of hot water with 6 g of sugar
Experimental: Baseline/Flavanol/Placebo
Participants consumed sugar water, a natural cocoa beverage containing 710 mg of flavanols, and an alkalized cocoa beverage, with a one-week washout period between interventions.
Dietary supplement: Flavanol
Natural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Dietary supplement: Placebo
Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Other: Sugar water
250 mL of hot water with 6 g of sugar
Experimental: Placebo/Baseline/Flavanol
Participants consumed an alkalized cocoa beverage, sugar water, and a natural cocoa beverage containing 710 mg of flavanols, with a one-week washout period between interventions.
Dietary supplement: Flavanol
Natural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Dietary supplement: Placebo
Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Other: Sugar water
250 mL of hot water with 6 g of sugar
Experimental: Placebo/Flavanol/Baseline
Participants consumed an alkalized cocoa beverage, a natural cocoa beverage containing 710 mg of flavanols, and sugar water, with a one-week washout period between interventions.
Dietary supplement: Flavanol
Natural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Dietary supplement: Placebo
Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Other: Sugar water
250 mL of hot water with 6 g of sugar
Experimental: Flavanol/Baseline/Placebo
Participants consumed a natural cocoa beverage containing 710 mg of flavanols, sugar water, and an alkalized cocoa beverage, with a one-week washout period between interventions.
Dietary supplement: Flavanol
Natural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Dietary supplement: Placebo
Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Other: Sugar water
250 mL of hot water with 6 g of sugar
Experimental: Flavanol/Placebo/Baseline
Participants consumed a natural cocoa beverage containing 710 mg of flavanols, an alkalized cocoa beverage, and sugar water, with a one-week washout period between interventions.
Dietary supplement: Flavanol
Natural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Dietary supplement: Placebo
Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Other: Sugar water
250 mL of hot water with 6 g of sugar

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Spatial cueing task - accuracy
Time Frame: 1 hour 40 minutes post-ingestion
Difference in the total accuracy (%)
1 hour 40 minutes post-ingestion
Spatial cueing task - reaction time
Time Frame: 1 hour 40 minutes post-ingestion
Difference in the reaction time (ms) for correct responses
1 hour 40 minutes post-ingestion
Visual search task - accuracy
Time Frame: 1 hour 40 minutes post-ingestion
Difference in the total accuracy (%)
1 hour 40 minutes post-ingestion
Visual search task - reaction time
Time Frame: 1 hour 40 minutes post-ingestion
Difference in the reaction time (ms) for correct responses
1 hour 40 minutes post-ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Konya Necmettin Erbakan Üniversitesi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oğuz Karataş, Ph.D., Konya Necmettin Erbakan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 122K636

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD collected throughout the trial

IPD Sharing Time Frame

Beginning 3 months after publication with no end date.

IPD Sharing Access Criteria

A proposal that describes planned analyses must be submitted

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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