UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030479 |
|---|---|
| Receipt number | R000034670 |
| Scientific Title | Effects of intake of olive fruit extract on fatigue, muscle soreness and vascular function |
| Date of disclosure of the study information | 2018/01/05 |
| Last modified on | 2018/01/19 13:59:59 |
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Basic information
Public title
Effects of intake of olive fruit extract on fatigue, muscle soreness and vascular function
Acronym
Effects of intake of olive fruit extract on fatigue, muscle soreness and vascular function
Scientific Title
Effects of intake of olive fruit extract on fatigue, muscle soreness and vascular function
Scientific Title:Acronym
Effects of intake of olive fruit extract on fatigue, muscle soreness and vascular function
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of intake of olive fruit extract on fatigue, muscle soreness and vascular function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Subjective degree of fatigue
Key secondary outcomes
Subjective degree of muscle soreness
Salivary cortisol concentration
Salivary SIgA concentration
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
[Olive fruit extract group]:intake jelly contains 60 mg of maslinic acid for a week
Interventions/Control_2
[Placebo group]:intake jelly not contains maslinic acid for a week
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
Water Polo Expert
Key exclusion criteria
Restriction underwater exercise
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Takemasa |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-2762
takemasa.tohru.gm@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Myoenzono Kanae |
Organization
University of Tsukuba
Division name
Doctoral Program in Sports Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-5990
Homepage URL
s1730400@s.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
NIPPON FLOUR MILLS CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 05 | 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
| 2017 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 20 | Day |
Last modified on
| 2018 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034670
