UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045442 |
|---|---|
| Receipt number | R000051880 |
| Scientific Title | The effect of intake of tea catechins and specific amino acid on human exercise performance |
| Date of disclosure of the study information | 2021/09/13 |
| Last modified on | 2021/09/10 10:21:02 |
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Basic information
Public title
The effect of intake of tea catechins and specific amino acid on human exercise performance
Acronym
The effect of intake of tea catechins and specific amino acid on human exercise performance
Scientific Title
The effect of intake of tea catechins and specific amino acid on human exercise performance
Scientific Title:Acronym
The effect of intake of tea catechins and specific amino acid on human exercise performance
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of intake of tea catechins and specific amino acid on exercise performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Anaerobic threshold
Key secondary outcomes
-Onset of blood lactate accumulation
-Exercise heart rate
-Rate of perceived exertion
-VO2max
-VO2 during constant intensity exercise load
-Questionnaire about fatigue
-Blood ammonia concentration
-Blood glucose concentration
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake foods and drinks containing tea catechins and specific amino acids for 4 weeks, and exercise on the final day. ->Washout for more than 2 weeks -> Intake foods and drinks these do not contain tea catechins and specific amino acids for 4 weeks, and exercise on the final day.
Interventions/Control_2
Intake foods and drinks those do not contain tea catechins and specific amino acids for 4 weeks, and exercise on the final day. -> Washout for more than 2 weeks -> Intake foods and drinks containing tea catechins and specific amino acids for 4 weeks, and exercise on the final day.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Healthy men aged 20 to 65
2.Subjects who can measure physical fitness
3.Subjects who have experienced high-intensity exercise within the past year without problems such as injury, dizziness, nausea, anemia, and dyspnea.
4.Subjects who exercise moderately or higher intensity once a month for 30 minutes or more
5.Subjects who can follow the instructions of the person in charge of the research
6.Subjects who are enrolled in the Kao Tochigi Plant during the test period and can participate in the test
Key exclusion criteria
1.Subjects with diseases such as liver, kidney, heart, lung, digestive organs, blood, endocrine system and metabolic system
2.Subjects who take antihypertensive drugs or antithrombotic drugs
3.Heart failure patients and a person with a history of myocardial infarction
4.Subjects who have a history of seizures based on nervous system diseases (loss of consciousness, coma, convulsions, etc.)
5.Subjects who plan or wish to have some vaccination between 10 days before the pre-measurement and the final measurement
6.Subjects who drink alcohol (alcohol equivalent of 50 g or more / day more than 5 days a week)
7.Food allergy to wheat, eggs, milk, soybean, apple, pork, and, ingredients derived from gelatin etc.
8.Subjects who have chronic anemia symptoms or who have been pointed out by a doctor
9.Subjects who currently have a breakdown in the lower limb locomotorium, or subjects who have had it within the past 3 months
10.Subjects with lower physical strength / exercise ability (a person who can not do the bicycle pedaling movement of constant rhythm, a person who can not do persistence exercise for more than 20 minutes)
11.Subjects who are not particularly good at collecting blood (including fingertip puncture blood collection)
12.Subjects who are prohibited from exercising or strenuous movement by a doctor
13.Subjects who have fever, respiratory symptoms, etc. within 2 weeks or who have had close contact with people infected with COVID-19
14.Subjects judged not appropriate by the lead principal investigator or investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Misawa |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-7268
misawa.koichi@kao.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Hasumura |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7236
Homepage URL
hasumura.takahiro@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.com
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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 13 | 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
| 2021 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 01 | 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
| 2021 | Year | 09 | Month | 10 | Day |
Last modified on
| 2021 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051880
