UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041723 |
|---|---|
| Receipt number | R000047603 |
| Scientific Title | The investigation of the effects of changes in sports performance on sweat lactate |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2020/09/07 11:46:54 |
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Basic information
Public title
The investigation of the effects of changes in sports performance on sweat lactate
Acronym
The investigation of the effects of changes in sports performance on sweat lactate
Scientific Title
The investigation of the effects of changes in sports performance on sweat lactate
Scientific Title:Acronym
The investigation of the effects of changes in sports performance on sweat lactate
Region
| Japan |
Condition
Condition
None (healthy individual)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is performed to investigate how changes in exercise performance due to the intervention affect data obtained by non-invasive methods, such as saliva and sweat by comparing between the non-invasive obtained data, include those from tissue/body fluid electrolyte/organic compound in saliva and sweat, and the minimally invasive obtained data from blood or lifestyle data.
Basic objectives2
Others
Basic objectives -Others
exploratory study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sweat lactate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants intake one 500ml bottle of commercially available BCAA-containing water in the morning, noon and evening (3 bottles per day in total) for 6 days. On the seventh day (measurement day), they intake one bottle of the same drink as above in the morning and at lunch before post-intervention measurement.
Interventions/Control_2
Participants intake one 500ml bottle of water in the morning, noon and evening (3 bottles per day in total) for 6 days. On the seventh day (measurement day), they intake one bottle of the same drink as above in the morning and at lunch before post-intervention measurement.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
consented healthy volunteers (College students and above)
Key exclusion criteria
1) complication or history of disease or injury which may affect sports performance
2) habitual intake of supplements used in this intervention
3) smokers
4) dietary habits (e.g., taking supplements) or medication that may affect exercise tolerance
5) experience in participating any other previous study that affects sports performance
6) pregnant, intending to be pregnant for the duration of the study, or breastfeeding
7) participant who the principal investigator determines inappropriate in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Nagura |
Organization
Keio University
Division name
School of medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-5363-3812
nagura@keio.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Nakashima |
Organization
Keio University
Division name
School of medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-5363-3812
Homepage URL
nakashima@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
03-5363-3812
med-rinri-jimu@adst.keio.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
| 2020 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 08 | Day |
Last modified on
| 2020 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047603
