UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035484 |
|---|---|
| Receipt number | R000040424 |
| Scientific Title | The effect of intake of specific food ingredients on human endurance and fatigue |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2019/07/16 14:42:57 |
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Basic information
Public title
The effect of intake of specific food ingredients on human endurance and fatigue
Acronym
The effect of intake of specific food ingredients on human endurance and fatigue
Scientific Title
The effect of intake of specific food ingredients on human endurance and fatigue
Scientific Title:Acronym
The effect of intake of specific food ingredients on human endurance and fatigue
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 effects of the intake of tea catechins and amino acids on the blood component during exercise and human endurance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Endurance on last day of each period (2 days)
Key secondary outcomes
Blood component fluctuation, saliva component fluctuation, heart rate variability, rate of perceived exertion (RPE), visual analog scale (VAS) for fatigue at exercise test on last day of each period (2 days)
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of specific food ingredients for 2 days and exercise on the final day.->Washout more than 6 days.->Intake of placebo (without specific food ingredients) for 2 days and exercise on the final day.
Interventions/Control_2
Intake of placebo (without specific food ingredients) for 2 days and exercise on the final day.->Washout more than 2 weeks.->Intake of specific food ingredients for 2 days 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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1.A person who is healthy men of 20 to 39 years old
2.A person who can receive physical fitness measurement
3.A person with exercise habits of about once a week
4.A person who is able to comply with the instructions of the person in charge of research
5.A person who is in the Kao Tochigi Plant during the examination period and who can participate in the exam
Key exclusion criteria
1.A person with serious diseases such as liver, kidney, heart, lung, digestive organs, blood, endocrine system and metabolic system
2.Heart failure patients and a person with a history of myocardial infarction
3.A person who has a history of seizures based on nervous system diseases (loss of consciousness, coma, convulsions, etc.)
4.A person with abnormal sugar / lipid metabolism
5.A person who drinks alcohol (alcohol equivalent of 20 g / day or more)
6.Food allergy to wheat, eggs, milk, soybean, apple, pork, and, ingredients derived from gelatin etc
7.A person with severe anemia
8.A person who currently has trouble in the lower limb exercise machine, or who had it within the past 3 months
9.A person 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)
10.A person who is prohibited from exercising or intense movement from a doctor
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Minegishi |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7817
minegishi.yoshihiko@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
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7817
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
+81-3-5630-9220
uesaka.toshio@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
| 2019 | Year | 05 | 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
8
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
| 2018 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 09 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 09 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 08 | Day |
Last modified on
| 2019 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040424
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