UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024118 |
|---|---|
| Receipt number | R000027765 |
| Scientific Title | Effects of nutritional intervention on physical function and sport injury in Japanese female athletes : A randomized double-blind, placebo-controlled study |
| Date of disclosure of the study information | 2016/11/04 |
| Last modified on | 2017/05/26 17:09:41 |
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Basic information
Public title
Effects of nutritional intervention on physical function and sport injury in Japanese female athletes : A randomized double-blind, placebo-controlled study
Acronym
Effects of nutritional intervention on physical function and sport injury in Japanese female athletes
Scientific Title
Effects of nutritional intervention on physical function and sport injury in Japanese female athletes : A randomized double-blind, placebo-controlled study
Scientific Title:Acronym
Effects of nutritional intervention on physical function and sport injury in Japanese female athletes
Region
| Japan |
Condition
Condition
Healthy subject (aged 17 and over)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of nutritional intervention on physical function and sport injury in healthy subject.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endurance performance, muscle strength, incidence of sports injury and competition score at pre-intervention, after 3 months intervention, and 1 month after finishing intervention
Key secondary outcomes
Body composition, energy metabolism markers, and tissue damage markers at pre-intervention, after 3 months intervention, and 1 month after finishing intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily intake of the active test drink (500ml/day) in athletic club activity or daily activity for 3 months.
Interventions/Control_2
Daily intake of the placebo test drink (500ml/day) in athletic club activity or daily activity for 3 months.
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
| 17 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
-Female university student-athletes who belong to athletic clubs
Key exclusion criteria
-A person who has had severe diseases or the past illness on liver, kidney, heart, lung, digestive organs, blood, endocrine, nerve and metabolic system.
-A Person who takes medication for glucose or fat metabolism, or hypertension.
-A smoker
-A heavy drinker (20g alcohol per day)
-A person who drink more than 6 cup of tea, coffee, green tea a day.
-A person who has stopped menstruating for 3 or more months.
-A person with severe anemia
-A person who are not eligible due to medical doctor's judgment.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyasu Ota |
Organization
Kao Corporation
Division name
Biological Science Laboratories
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7828
ota.noriyasu@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Minegishi |
Organization
Kao Corporation
Division name
Biological Science Laboratories
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7817
Homepage URL
yoshihiko.minegishi@kao.co.jp
Sponsor or person
Institute
Kao Corporation
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
Niigata University of Health and Welfare
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
新潟医療福祉大学（新潟県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 04 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 05 | Month | 26 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 21 | Day |
Last modified on
| 2017 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027765
