UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032487
Receipt No. R000037047
Scientific Title Anti-fatigue effects of olive-oil administration in cross-over study.
Date of disclosure of the study information 2019/03/31
Last modified on 2018/05/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Anti-fatigue effects of olive-oil administration in cross-over study.
Acronym The anti-fatigue effects of olive-oil administration.
Scientific Title Anti-fatigue effects of olive-oil administration in cross-over study.
Scientific Title:Acronym The anti-fatigue effects of olive-oil administration.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Administration of the anti-fatigue effects of Olive oil.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in autonomic nerve function, oxidation stress, antioxidant activity, cognitive function, sleep state and subjective fatigue after 4-weeks administration.
Key secondary outcomes Amount of daily activity

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
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 Administration of test oil for 4 weeks. / Wash out for 4 weeks. / Administration of placebo oil for 4 weeks.
Interventions/Control_2 Administration of placebo oil for 4 weeks. / Wash out for 4 weeks. / Administration of test oil 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
65 years-old >
Gender Male and Female
Key inclusion criteria 1.Healthy persons who are aged from 20 to 64 years.
2.Persons who can give written informed consents.
Key exclusion criteria 1.Persons who are in treatment.
2.Persons who have medical history of cardiovascular disease.
3.Persons who have autonomic nervous system dysfunction.
4.Persons who have medical history of nervous system disease such as unconsciousness, coma, convulsion, etc.
5.Persons who have insomnia.
6.Persons who have food allergy.
7.Persons who are heavy user of alcohol.
8.Persons whose body mass index is less than 17 and more than 31.
9.Persons who are on a diet.
10.Pregnant women.
11.Persons who usually take in olive oil.
12.Persons who have past or current medical history of serious disease such as diabetes mellitus, hepatic disease, kidney disease, cardiac disease, cholelithiasis, etc.
13.Persons who are now participating in other clinical trials, or participated in other clinical trials within a month before obtaining his/her informed consent in this trial.
14.Persons who are judged not suitable to participate in this trial by investigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyoshi Watanabe
Organization Osaka City University
Division name Center for Health Science Innovation
Zip code
Address 9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL 06-6485-0288
Email chsi-b@ado.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Mizuno
Organization Osaka City University
Division name Center for Health Science Innovation
Zip code
Address 9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL 06-6485-0288
Homepage URL
Email chsi-b@ado.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Center for Health Science Innovation
Institute
Department

Funding Source
Organization Kagawa Prefecture
Organization
Division
Category of Funding Organization Local Government
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 大阪市立大学健康科学イノベーションセンター(大阪)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 31 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 06 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 18 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
2018 Year 05 Month 07 Day
Last modified on
2018 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037047

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.