UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029621 |
|---|---|
| Receipt number | R000033837 |
| Scientific Title | The effect of intake of specific food ingredients on human endurance |
| Date of disclosure of the study information | 2017/10/19 |
| Last modified on | 2018/06/20 12:35:42 |
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Basic information
Public title
The effect of intake of specific food ingredients on human endurance
Acronym
The effect of intake of specific food ingredients on human endurance
Scientific Title
The effect of intake of specific food ingredients on human endurance
Scientific Title:Acronym
The effect of intake of specific food ingredients on human endurance
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 specific food ingredients on 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 weeks).
Key secondary outcomes
Blood component variation on the last day of each period.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake foods (supplements)/drinks containing specific food ingredients for 2 weeks and exercise on the final day.->Washout more than 2 days.->Intake foods (supplements)/drinks not containing specific food ingredients for 2 weeks and exercise on the final day.
Interventions/Control_2
Intake foods (supplements)/drinks not containing specific food ingredients for 2 weeks and exercise on the final day. ->Washout more than 2 days.->Intake foods (supplements)/drinks containing specific food ingredients for 2 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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1.A person who can receive physical fitness measurement
2.A person with exercise habits of about once a month
3.A person who is not prohibited from exercising by doctors
4.A person who is able to comply with the instructions of the person in charge of research and research and the medical staff involved in this 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 thyroid function
5.A person with abnormal sugar / lipid metabolism
6.A person receiving treatment with hyperlipemia medication or hyperglycemia treatment
7.A person who drinks alcohol (alcohol equivalent of 20 g / day or more)
8.A person who had weight changes of +/- 3 kg or more during the 3 months before the start of the test food ingredients
9.A person who has a history of hypersensitivity with respect to the components of the test food
10.Food allergy to eggs, milk, wheat, beef, soybean, chicken, pork, seafood, ingredients derived from gelatin etc
11.A person who is ingesting foods for specified health use, supplements, diet foods and who can not withhold intake during the test period
12.A person who drinks more than 6 cups of tea, coffee, tea on a daily basis
13.A person with severe anemia
14.A person who currently has trouble in the lower limb exercise machine, or who had it within the past year
15.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)
16.A person who is prohibited from exercising or intense movement from a doctor
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Minegishi |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7817
minegishi.yoshihiko@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Hasumura |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7817
Homepage URL
hasumura.takahiro@kao.co.jp
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
Address
Tel
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
| 2017 | Year | 10 | Month | 19 | 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
| 2017 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 19 | Day |
Last modified on
| 2018 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033837
