UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055369 |
|---|---|
| Receipt number | R000063279 |
| Scientific Title | The impacts of flavanol-rich cocoa consumption on cerebrovascular nits |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/09/01 16:38:53 |
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Basic information
Public title
The impacts of flavanol-rich cocoa consumption on brain functions
Acronym
Is cacao good for brain health?
Scientific Title
The impacts of flavanol-rich cocoa consumption on cerebrovascular nits
Scientific Title:Acronym
Flavanol and cerebral circulations
Region
| Japan |
Condition
Condition
Healthy young individuals
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is well known that flavanol-rich cocoa consumption improves cognitive function but the physiological mechanism(s) remains unclear. The present study will examine whether dynamic cerebral autoregulation during cognitive activity, cerebrovascular endothelial function, and neurovascular coupling are improved after flavanol-rich cocoa consumption, along with cognitive improvement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Measurements
- dynamic cerebral autoregulation (Middle and posterior cerebral arterial blood flow velocity)
- cerebral and peripheral vascular endothelial function (Internal carotid artery and brachial artery)
- Neurovascular coupling (cerebral blood velocity and oxygenation)
- Cognitive functions (memory and executive function)
- Mood (Mental fatigue and ability to concentration etc.)
These measurements will be measured after a single intake of flavanol-rich cocoa.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Flavanol-rich cocoa
Interventions/Control_2
low flavanol cocoa
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy individuals, non-smoker
Key exclusion criteria
take medications and an allergy for cacao
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Tsukamoto |
Organization
Waseda University
Division name
faculty of sport sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 JAPAN
TEL
04299476772
hayato.tsukamoto@aoni.waseda.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Tsukamoto |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 JAPAN
TEL
04299476772
Homepage URL
hayato.tsukamoto@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Hayato Tsukamoto
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
2100 Kujirai, Kawagoe, Saitama, JAPAN
Tel
049-239-1440
mlkks@toyo.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063279
