UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of nutritional intervention on physical function and sport injury in Japanese female athletes : A randomized double-blind, placebo-controlled study
Title of the study (Brief title)	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	Noriyasu Ota
Organization	Kao Corporation
Division name	Biological Science Laboratories
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	Yoshihiko Minegishi
Organization	Kao Corporation
Division name	Biological Science Laboratories
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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