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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021315
Receipt No. R000024480
Scientific Title Effect of polyphenol extract-containing beverage intake on the sweat rate and skin blood flow under the hot environment
Date of disclosure of the study information 2016/03/03
Last modified on 2016/03/03

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Basic information
Public title Effect of polyphenol extract-containing beverage intake on the sweat rate and skin blood flow under the hot environment
Acronym Effect of polyphenol extract-containing beverage intake on the thermoregulatory function under the hot environment
Scientific Title Effect of polyphenol extract-containing beverage intake on the sweat rate and skin blood flow under the hot environment
Scientific Title:Acronym Effect of polyphenol extract-containing beverage intake on the thermoregulatory function under the hot environment
Region
Japan

Condition
Condition healthy adult male
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examined the effects of polyphenol extract-containing beverage intake on the sweat rate and skin blood flow during heat environment in human
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes sweat rate
skin blood flow
body temperature
Key secondary outcomes

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 3
Purpose of intervention Prevention
Type of intervention
Food Maneuver
Interventions/Control_1 Polyphenol extract
Interventions/Control_2 ion beverage
Interventions/Control_3 mineral water
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 Healthy adult male
Key exclusion criteria Non-healthy people with digestive disorders, etc.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Iwase
Organization Aichi Medical University
Division name Department of Physiology
Zip code
Address 1-1. Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Email s_iwase@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Nishimura
Organization Aichi Medical University
Division name Department of Physiology
Zip code
Address 1-1. Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Homepage URL
Email nao2460@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

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
Email

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 愛知医科大学(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 15 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 03 Month 03 Day
Last modified on
2016 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024480

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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