UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054033 |
|---|---|
| Receipt number | R000061641 |
| Scientific Title | Impact of the Timing of Caffeine Ingestion on Endurance Exercise Performance Based on the CYP1A2 Genotype |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/10/01 09:43:58 |
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Basic information
Public title
Trial of the effects of caffeine intake timing on endurance performance: based on genotype
Acronym
Caffeine intake timing trial
Scientific Title
Impact of the Timing of Caffeine Ingestion on Endurance Exercise Performance Based on the CYP1A2 Genotype
Scientific Title:Acronym
Caffeine intake timing on endurance performance trial
Region
| Japan |
Condition
Condition
Endurance performance
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to clear up whether the timing of caffeine intake affects endurance exercise performance differently depending on the CYP1A2 genotype.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The duration of 10 km cycling time trial 120 minutes after the administration of the first capsule in each experiment
Key secondary outcomes
Heart rate, blood pressure, expired gases (oxygen uptake, carbon dioxide output, ventilation, respiratory exchange ratio), cardiac output, stroke volume, rate of perceived exertion (RPE) 120 minutes after the administration of the first capsule in each 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
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Subjects ingest capsules containing 6 mg of caffeine per 1 kilogram of body weight. Ninety minutes later, they take a placebo capsule. Cycling time trial begins 30 minutes after ingesting the second capsule.
Interventions/Control_2
Subjects take a placebo capsule. Ninety minutes later, they ingest capsules containing 6 mg of caffeine per 1 kilogram of body weight. Cycling time trial begins 30 minutes after ingesting the second capsule.
Interventions/Control_3
Subjects take placebo capsules both initially and after 90 minutes. Cycling time trial begins 30 minutes after ingesting the second capsule.
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
Key inclusion criteria
Healthy male aged 18 to 30 years old
Key exclusion criteria
Smokers
Medication users
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
TEL
04-2947-6745
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
TEL
04-2947-6833
Homepage URL
teisinnseitaku@akane.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Procedures concerning Research with Human Subjects at Waseda University
Address
1-104 Totsuka-cho, Shinjyuku-ku, Tokyo 169-8050
Tel
03-5272-1639
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
| 2024 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061641
