Healthy Young AdultsNCT06812689
The Acute Effects of Cocoa Flavanols Intake on Overt and Covert Attention
A study testing Flavanol and Sugar water in people with Healthy Young Adults, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- Flavanol and Sugar water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Nov 2022to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal or corrected-to-normal visual acuity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Necmettin Erbakan University Cognitive Psychology Laboratuary
Konya, Konya, 42090
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Young Adults
- Being tested
- Flavanol, Placebo, Sugar water
- Keywords
- cocoa flavanols, overt attention, covert attention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlavanolDietary supplement
Natural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
PlaceboDietary supplement
Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.
Sugar waterOther
250 mL of hot water with 6 g of sugar
| Study group | Role | What they receive |
|---|---|---|
| Baseline/Placebo/Flavanol | Experimental | 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. Receives: Dietary Supplement: Flavanol; Dietary Supplement: Placebo; Other: Sugar water |
| Baseline/Flavanol/Placebo | Experimental | 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. Receives: Dietary Supplement: Flavanol; Dietary Supplement: Placebo; Other: Sugar water |
| Placebo/Baseline/Flavanol | Experimental | 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. Receives: Dietary Supplement: Flavanol; Dietary Supplement: Placebo; Other: Sugar water |
| Placebo/Flavanol/Baseline | Experimental | 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. Receives: Dietary Supplement: Flavanol; Dietary Supplement: Placebo; Other: Sugar water |
| Flavanol/Baseline/Placebo | Experimental | 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. Receives: Dietary Supplement: Flavanol; Dietary Supplement: Placebo; Other: Sugar water |
| Flavanol/Placebo/Baseline | Experimental | 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. Receives: Dietary Supplement: Flavanol; Dietary Supplement: Placebo; Other: Sugar water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial cueing task - accuracy
Difference in the total accuracy (%)
Measured: 1 hour 40 minutes post-ingestion
Spatial cueing task - reaction time
Difference in the reaction time (ms) for correct responses
Measured: 1 hour 40 minutes post-ingestion
Visual search task - accuracy
Difference in the total accuracy (%)
Measured: 1 hour 40 minutes post-ingestion
Visual search task - reaction time
Difference in the reaction time (ms) for correct responses
Measured: 1 hour 40 minutes post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start26 Nov 2022
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy Young AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Oğuz Karataş, Konya Necmettin Erbakan Üniversitesi
- Investigators
- Oğuz Karataş, Ph.D., Principal investigator, Konya Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812689
- Sponsor's protocol ID
- 122K636
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
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.
PubMed 26047963Francis 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.
PubMed 16794461
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Cocoa Flavanols Intake on Overt and Covert Attention: a Randomized, Double-blind Crossover Trial
- ClinicalTrials.gov ID
- NCT06812689
- Acronym / sponsor ID
- 122K636
- Conditions
- Healthy Young Adults
- Keywords
- cocoa flavanols, overt attention, covert attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 26 Nov 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Baseline/Placebo/Flavanol | Experimental | Dietary Supplement: Flavanol, Dietary Supplement: Placebo, Other: Sugar waterParticipants 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. |
| Baseline/Flavanol/Placebo | Experimental | Dietary Supplement: Flavanol, Dietary Supplement: Placebo, Other: Sugar waterParticipants 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. |
| Placebo/Baseline/Flavanol | Experimental | Dietary Supplement: Flavanol, Dietary Supplement: Placebo, Other: Sugar waterParticipants 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. |
| Placebo/Flavanol/Baseline | Experimental | Dietary Supplement: Flavanol, Dietary Supplement: Placebo, Other: Sugar waterParticipants 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. |
| Flavanol/Baseline/Placebo | Experimental | Dietary Supplement: Flavanol, Dietary Supplement: Placebo, Other: Sugar waterParticipants 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. |
| Flavanol/Placebo/Baseline | Experimental | Dietary Supplement: Flavanol, Dietary Supplement: Placebo, Other: Sugar waterParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal or corrected-to-normal visual acuity
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlavanolNatural cocoa powder containing 710 mg of flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar. | Dietary supplement | Baseline/Flavanol/Placebo, Baseline/Placebo/Flavanol, Flavanol/Baseline/Placebo, Flavanol/Placebo/Baseline, Placebo/Baseline/Flavanol, Placebo/Flavanol/Baseline |
| PlaceboAlkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar. | Dietary supplement | Baseline/Flavanol/Placebo, Baseline/Placebo/Flavanol, Flavanol/Baseline/Placebo, Flavanol/Placebo/Baseline, Placebo/Baseline/Flavanol, Placebo/Flavanol/Baseline |
| Sugar water250 mL of hot water with 6 g of sugar | Other | Baseline/Flavanol/Placebo, Baseline/Placebo/Flavanol, Flavanol/Baseline/Placebo, Flavanol/Placebo/Baseline, Placebo/Baseline/Flavanol, Placebo/Flavanol/Baseline |
Primary outcome
Spatial cueing task - accuracy
Time frame: 1 hour 40 minutes post-ingestion
Difference in the total accuracy (%)
Spatial cueing task - reaction time
Time frame: 1 hour 40 minutes post-ingestion
Difference in the reaction time (ms) for correct responses
Visual search task - accuracy
Time frame: 1 hour 40 minutes post-ingestion
Difference in the total accuracy (%)
Visual search task - reaction time
Time frame: 1 hour 40 minutes post-ingestion
Difference in the reaction time (ms) for correct responses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- BackgroundKarataş 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
- Background: PubMed 26047963Lamport 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.
- Background: PubMed 16794461Francis 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.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oğuz Karataş, Ph.D. principal investigator
Konya Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavanol and Sugar water in people with Healthy Young Adults, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial cueing task - accuracy (time frame: 1 hour 40 minutes post-ingestion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06812689, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.