UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048643 |
|---|---|
| Receipt number | R000055413 |
| Scientific Title | Association between sports drink intake and exercise performance in long-distance athletes. |
| Date of disclosure of the study information | 2022/08/31 |
| Last modified on | 2023/12/27 18:00:51 |
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Basic information
Public title
Association between sports drink intake and exercise performance in long-distance athletes.
Acronym
Sports drink intake and exercise performance.
Scientific Title
Association between sports drink intake and exercise performance in long-distance athletes.
Scientific Title:Acronym
Sports drink intake and exercise performance.
Region
| Japan |
Condition
Condition
healthy college athletes
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine how blood glucose levels change with the consumption of isotonic or hypotonic beverages during exercise, and whether there are differences in fatigue and time records.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Fatigue levels, blood glucose levels, and time records for 1000m.
Key secondary outcomes
water intake, body weight change
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Hypotonic beverages, free intake
Interventions/Control_2
Isotonic beverages, free intake
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy long-distance college athletes
Key exclusion criteria
Persons infected or suspected of being infected with COVID-19.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Ohta |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences
Zip code
813-8529
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka, Japan
TEL
092-661-2411
m-ohta@fwu.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Ohta |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences
Zip code
813-8529
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka, Japan
TEL
092-661-2411
Homepage URL
m-ohta@fwu.ac.jp
Sponsor or person
Institute
Fukuoka Women's University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Women's 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
Ethical Committee of Fukuoka Women's University
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka, Japan
Tel
092-661-2411
soumu@fwu.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
| 2022 | Year | 08 | Month | 31 | 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
10
Results
Beverage intake was significantly higher for hypotonic beverages than for isotonic ones (p=0.017).
When the time-series change in fatigue by VAS was compared with the area under the curve, hypotonic beverages tended to be smaller than isotonic ones (p=0.084).
There were no differences between beverage types in sweat rate, blood glucose variation, 1000m time, or the mood scale POMS.
Results date posted
| 2023 | Year | 12 | Month | 27 | Day |
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
Main results already published
Date of protocol fixation
| 2022 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 10 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055413
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
