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

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 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


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

Value
https://center6.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