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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014659
Receipt No. R000017053
Scientific Title Effects of serial polyphenol extract-containing carbonated beverages and heat load by bathing on energy expenditure and the autonomic nervous system in human
Date of disclosure of the study information 2014/07/26
Last modified on 2016/08/01

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Basic information
Public title Effects of serial polyphenol extract-containing carbonated beverages and heat load by bathing on energy expenditure and the autonomic nervous system in human
Acronym Effects of serial polyphenol extract-containing carbonated beverages and heat load by bathing on energy expenditure in human
Scientific Title Effects of serial polyphenol extract-containing carbonated beverages and heat load by bathing on energy expenditure and the autonomic nervous system in human
Scientific Title:Acronym Effects of serial polyphenol extract-containing carbonated beverages and heat load by bathing on energy expenditure in human
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 serial intake of polyphenol extract-containing carbonated beverages and heat load by bathing on the energy expenditure, thermoregulation and the autonomic nervous system in human.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Energy expenditure
Sweat rate
Cutaneous blood flow
Heart rate variability
Key secondary outcomes Continued intake of 2 weeks

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 Placebo beverage
Interventions/Control_3 Ion beverage
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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 26 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
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 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
2014 Year 07 Month 26 Day
Last modified on
2016 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017053

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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