UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024360 |
|---|---|
| Receipt number | 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 | 2021/02/11 14:35:36 |
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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 | Tomohiro |
| Middle name | |
| Last name | Okura |
Organization
University of Tsukuba
Division name
Faculty of Health and sport science
Zip code
305-8550
Address
1-1-1 Tennodai, Tsukuba
TEL
029-859-2733
okura@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Jieun |
| Middle name | |
| Last name | Yoon |
Organization
University of Tsukuba
Division name
Faculty of Health and sport science
Zip code
305-8550
Address
1-2 Kasuga, Tsukuba
TEL
029-859-1593
Homepage URL
yoon.jieun.fu@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
University of TSukuba
Address
418, 1-2KASUGA TSUKUBA
Tel
029-859-1593
yoon.jieun.fu@u.tsukuba.ac.jp
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
No
Publication of results
Unpublished
Result
URL related to results and publications
No
Number of participants that the trial has enrolled
0
Results
No
Results date posted
| 2021 | Year | 02 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No
Participant flow
No
Adverse events
No
Outcome measures
No
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 17 | Day |
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
| 2021 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027638
