- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06812689
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
48
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
Natural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
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.
|
Natural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
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.
|
Natural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
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.
|
Natural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
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.
|
Natural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
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.
|
Natural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
250 mL of hot water with 6 g of sugar
|
What is the study measuring?
Primary Outcome Measures
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.
Investigators
- 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
- Karataş O, Karabay A, Alıcı T. Uzun süreli kakao flavanolleri alımının bilişsel işlevlere ve duygudurumuna etkileri ve bu etkilerin altındaki fizyolojik mekanizmalar: Bir derleme çalışması. Türk Psikoloji Yazıları. 2022;25(49):1-26. http://dx.doi.org/10.31828/tpy1301996120211203m000043
- Lamport DJ, Pal D, Moutsiana C, Field DT, Williams CM, Spencer JP, Butler LT. The effect of flavanol-rich cocoa on cerebral perfusion in healthy older adults during conscious resting state: a placebo controlled, crossover, acute trial. Psychopharmacology (Berl). 2015 Sep;232(17):3227-34. doi: 10.1007/s00213-015-3972-4. Epub 2015 Jun 7.
- Francis ST, Head K, Morris PG, Macdonald IA. The effect of flavanol-rich cocoa on the fMRI response to a cognitive task in healthy young people. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S215-20. doi: 10.1097/00005344-200606001-00018.
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)
November 26, 2022
Primary Completion (Actual)
January 20, 2023
Study Completion (Actual)
January 20, 2023
Study Registration Dates
First Submitted
February 1, 2025
First Submitted That Met QC Criteria
February 1, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 13, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID 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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