UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059479 |
|---|---|
| Receipt number | R000068028 |
| Scientific Title | The Role of Genetic Polymorphisms in the Effects of Caffeine Intake on Cognitive Function: A Randomized Double-Blind Crossover Trial Based on CYP1A2 Genotype |
| Date of disclosure of the study information | 2025/10/20 |
| Last modified on | 2025/10/21 11:36:26 |
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Basic information
Public title
The role of genetic polymorphisms in the effects of caffeine intake on cognitive function: based on CYP1A2 genotype
Acronym
A genetic study on caffeine and concentration
Scientific Title
The Role of Genetic Polymorphisms in the Effects of Caffeine Intake on Cognitive Function: A Randomized Double-Blind Crossover Trial Based on CYP1A2 Genotype
Scientific Title:Acronym
Caffeine Intake and Cognitive Function: The Role of Genetic Factors (CYP1A2 Genotype)
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to clarify whether the effects of caffeine intake timing on cognitive function differ according to CYP1A2 genotype.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The outcome measures in the Psychomotor Vigilance Task (PVT) include mean reaction time, the fastest and slowest 10% of reaction times, the number of lapses (reaction time > 500 ms), the number of false responses, and the variability of reaction times.
Key secondary outcomes
Subjective anxiety experienced by participants during the experiment
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Following caffeine ingestion (6 mg/kg, administered in capsule form), the Psychomotor Vigilance Task (PVT) was initiated 25 minutes post-administration and consisted of seven repetitions of a 10-minute PVT followed by a 5-minute rest period.
Interventions/Control_2
Following placebo ingestion (encapsulated in an identical capsule in appearance), the Psychomotor Vigilance Task (PVT) was initiated 25 minutes post-administration and consisted of seven repetitions of a 10-minute PVT followed by a 5-minute rest period.
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy males aged 18 to 39 years
Key exclusion criteria
Individuals with a history of chronic diseases
Individuals currently taking medication
Individuals with unstable sleep patterns
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kumpei |
| Middle name | |
| Last name | Tanisawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL
0429476745
tanisawa@waseda.jp
Public contact
Name of contact person
| 1st name | Jinxingze |
| Middle name | |
| Last name | Cheng |
Organization
Waseda University
Division name
Graduate School of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL
08058049614
Homepage URL
teisinnseitaku@akane.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University, Ethics Review Procedures concerning Research with Human Subjects
Address
1-104 Totsukacho, Shinjuku-ku, Tokyo 169-8050
Tel
0352721639
rinri@list.waseda.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
| 2025 | Year | 10 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068028
