UMIN-CTR Clinical Trial

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
Email	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
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025472