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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024118
Receipt No. 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

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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
Email 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
Email yoshihiko.minegishi@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027765

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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