UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058496 |
|---|---|
| Receipt number | R000066879 |
| Scientific Title | A Study on Nutrition facts Affecting Fatigue and Concentration during Sports Activities |
| Date of disclosure of the study information | 2025/07/19 |
| Last modified on | 2025/07/16 22:08:23 |
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Basic information
Public title
A Study on Nutrition facts Affecting Fatigue and Concentration during Sports Activities
Acronym
A Study on Nutrition facts Affecting Fatigue and Concentration during Sports Activities
Scientific Title
A Study on Nutrition facts Affecting Fatigue and Concentration during Sports Activities
Scientific Title:Acronym
A Study on Nutrition facts Affecting Fatigue and Concentration during Sports Activities
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To search for nutritional facts that affect the reduction of fatigue and the maintenance of concentration during sports activities
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Results of executive function test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
6% concentration carbohydrate solution 3.6mL
Interventions/Control_2
Exercise performance
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
People who is involved in sports in college or adult team
Key exclusion criteria
1. People who is allergic to foods and drugs
2. People with orthopedic diseases who is unable to participate in training due to pain
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Miwako |
| Middle name | |
| Last name | Deguchi |
Organization
Osaka Metropolitan University Graduate School of Human Life and Ecology
Division name
Department of Nutrition
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
06-6605-2882
deguchi@omu.ac.jp
Public contact
Name of contact person
| 1st name | Miwako |
| Middle name | |
| Last name | Deguchi |
Organization
Osaka Metropolitan University Graduate School of Human Life and Ecology
Division name
Department of Nutrition
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
06-6605-2882
Homepage URL
deguchi@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan Univerisity
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the Osaka Metropolitan University Graduate School of Human Life and Ecology
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
Tel
06-6605-2801
life-ethics@ml.omu.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
| 2025 | Year | 07 | Month | 19 | 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
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 07 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066879
