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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name