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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024360
Receipt No. R000027638
Scientific Title The evaluation for the effect of consumption of olive fruit extract on exercise.
Date of disclosure of the study information 2016/11/01
Last modified on 2017/04/12

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Basic information
Public title The evaluation for the effect of consumption of olive fruit extract on exercise.
Acronym The effect of consumption of olive fruit extract on exercise.
Scientific Title The evaluation for the effect of consumption of olive fruit extract on exercise.
Scientific Title:Acronym The effect of consumption of olive fruit extract on exercise.
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effect of olive fruit extract on exercise.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Fatigue measurement
Key secondary outcomes Lactate measurement

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of placebo for 4 weeks
Interventions/Control_2 Intake of olive fruit extract for 4 weeks
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria (1) Female soccer players
(2) Participants is fully informed about the study and has signed the information consent form
(3) No allergens from the olive
(4) Participant who gets motivated to this study
Key exclusion criteria (1) Person who is allergic to olive fruit extract
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiro Okura
Organization University of Tsukuba
Division name Faculty of Health and sport science
Zip code
Address 1-1-1 Tennodai, Tsukuba
TEL 029-859-2733
Email okura@taiiku.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jieun Yoon
Organization University of Tsukuba
Division name Faculty of Health and sport science
Zip code
Address 1-2 Kasuga, Tsukuba
TEL 029-859-1593
Homepage URL
Email yoon.jieun.fu@u.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 筑波大学(茨城県 つくば市)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 01 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 No longer recruiting
Date of protocol fixation
2016 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 17 Day
Last follow-up date
2017 Year 03 Month 28 Day
Date of closure to data entry
2017 Year 04 Month 30 Day
Date trial data considered complete
2017 Year 05 Month 30 Day
Date analysis concluded
2017 Year 07 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 11 Day
Last modified on
2017 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027638

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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