UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022091 |
|---|---|
| Receipt number | R000025472 |
| Scientific Title | The test of enhancing effects of metabolism and refreshed feeling by the combination of the amino acid mix ingestion and sauna bath. |
| Date of disclosure of the study information | 2016/04/27 |
| Last modified on | 2020/10/05 13:35:52 |
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Basic information
Public title
The test of enhancing effects of metabolism and refreshed feeling by the combination of the amino acid mix ingestion and sauna bath.
Acronym
The effects test of the combination of the amino acid mix ingestion and sauna bath.
Scientific Title
The test of enhancing effects of metabolism and refreshed feeling by the combination of the amino acid mix ingestion and sauna bath.
Scientific Title:Acronym
The effects test of the combination of the amino acid mix ingestion and sauna bath.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects which influence to metabolism and refreshed feeling in sauna bath by single ingestion of amino acid mixture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physiological index and refreshing feeling,on the day of the single ingestion.
*Blood flow of skin surface
*Amount of sweat
*Body surface temperature
*Visual analog scale
Key secondary outcomes
Physiological index,on the day of the single ingestion.
*Tympanic temperature
*Acceleration pulse wave
Blood test,on the day of the single ingestion.
*Metabolite of nitric oxide
*Cortisol
*Free fatty acid
Cognitive function test, on the day of the single ingestion.
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Amino acid mixture, single ingestion - Wash out 1 week - Placebo, single ingestion
Interventions/Control_2
Placebo, single ingestion - Wash out 1 week - Amino acid mixture, single ingestion
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
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Subjects who can make self-judgment and are voluntarily giving written informed consent.
2) Subject who can use personal sauna bath without unreasonable.
3) Healthy males aged 20 to 49 years old, who meet the followings at the day of screening test.
(1) Subjects who regarded as appropriate by the doctor from the results of screening test.
(2) Healthy males who have BMI value between 18.5 and 25.0.
(3) Health males who can conduct the cognitive function test.
Key exclusion criteria
1) Subjects who have previous and/or current medical history of malignant tumor, heart failure, myocardial infarction.
2) Subjects who have chronic disease and who are given continuous treatment by taking medicines.
3) Subjects who took drugs, quasi drugs, or supplements those concern about influence to the test results on daily basis within 3 month before screening test. Or, subjects who plan to take those drugs, quasi drugs, or supplements during test period.
4) Subjects who have previous medical history of drug and/or food allergy.
5) Subjects who difficult to sweat in sauna bath.
6) Subjects who excessive alcohol intake. (intake over 60g alcohol per day)
7) Subjects who have tattoo.
8) Subjects who have wide barns scar.
9) Subjects who removing hair.
10) Subjects who participated within 3-month prior to the current study and/or who plan to participate the other clinical tests.
11) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Sakano |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Plan Sales Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
| 2016 | Year | 04 | Month | 27 | 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
| 2016 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 27 | Day |
Last modified on
| 2020 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025472
