NCT06812689

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 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

November 26, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 1, 2025

Last Update Submit

February 13, 2025

Conditions

Keywords

cocoa flavanolsovert attentioncovert attention

Outcome Measures

Primary Outcomes (4)

  • Spatial cueing task - accuracy

    Difference in the total accuracy (%)

    1 hour 40 minutes post-ingestion

  • Spatial cueing task - reaction time

    Difference in the reaction time (ms) for correct responses

    1 hour 40 minutes post-ingestion

  • Visual search task - accuracy

    Difference in the total accuracy (%)

    1 hour 40 minutes post-ingestion

  • Visual search task - reaction time

    Difference in the reaction time (ms) for correct responses

    1 hour 40 minutes post-ingestion

Study Arms (6)

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.

Dietary Supplement: FlavanolDietary Supplement: PlaceboOther: 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.

Dietary Supplement: FlavanolDietary Supplement: PlaceboOther: 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.

Dietary Supplement: FlavanolDietary Supplement: PlaceboOther: 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.

Dietary Supplement: FlavanolDietary Supplement: PlaceboOther: 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.

Dietary Supplement: FlavanolDietary Supplement: PlaceboOther: 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.

Dietary Supplement: FlavanolDietary Supplement: PlaceboOther: Sugar water

Interventions

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.

Baseline/Flavanol/PlaceboBaseline/Placebo/FlavanolFlavanol/Baseline/PlaceboFlavanol/Placebo/BaselinePlacebo/Baseline/FlavanolPlacebo/Flavanol/Baseline
PlaceboDIETARY_SUPPLEMENT

Alkalized cocoa powder containing no flavanols was dissolved in 250 mL of hot water and sweetened with 6 g of sugar.

Baseline/Flavanol/PlaceboBaseline/Placebo/FlavanolFlavanol/Baseline/PlaceboFlavanol/Placebo/BaselinePlacebo/Baseline/FlavanolPlacebo/Flavanol/Baseline

250 mL of hot water with 6 g of sugar

Baseline/Flavanol/PlaceboBaseline/Placebo/FlavanolFlavanol/Baseline/PlaceboFlavanol/Placebo/BaselinePlacebo/Baseline/FlavanolPlacebo/Flavanol/Baseline

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal or corrected-to-normal visual acuity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Necmettin Erbakan University Cognitive Psychology Laboratuary

Konya, Konya, 42090, Turkey (Türkiye)

Location

Related Publications (3)

  • 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

    BACKGROUND
  • 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.

    PMID: 26047963BACKGROUND
  • 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.

    PMID: 16794461BACKGROUND

Study Officials

  • Oğuz Karataş, Ph.D.

    Konya Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2025

First Posted

February 6, 2025

Study Start

November 26, 2022

Primary Completion

January 20, 2023

Study Completion

January 20, 2023

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

All IPD collected throughout the trial

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 3 months after publication with no end date.
Access Criteria
A proposal that describes planned analyses must be submitted

Locations