UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014659 |
|---|---|
| Receipt number | 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 | 2020/08/19 15:44:15 |
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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 | Satoshii |
| Middle name | |
| Last name | Iwase |
Organization
Aichi Medical University
Division name
Department of Physiology
Zip code
480-1195
Address
1-1, Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
s_iwase@nifty.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Nishimura |
Organization
Aichi Medical University
Division name
Department of Physiology
Zip code
480-1195
Address
1-1, Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
Homepage URL
nao2460@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
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
Aichi Medical University
Address
1-1, Yazakokarimata, Nagakute, Aichi
Tel
0561-62-3311
nao2460@aichi-med-u.ac.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
| 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
| 2020 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017053
