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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041723
Receipt No. 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

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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
Email 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
Email nakashima@keio.jp

Sponsor
Institute Keio University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047603

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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