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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034391
Receipt No. R000039205
Scientific Title Investigation for the effects of Olive leaf on human health in cross-over study.
Date of disclosure of the study information 2019/03/31
Last modified on 2019/04/26

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Basic information
Public title Investigation for the effects of Olive leaf on human health in cross-over study.
Acronym Investigation for the effects of Olive leaf on human health.
Scientific Title Investigation for the effects of Olive leaf on human health in cross-over study.
Scientific Title:Acronym Investigation for the effects of Olive leaf on human health.
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 leaf.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in oxidation stress and antioxidant activity after the administration for 4weeks
Key secondary outcomes Subjective fatigue sensation

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 YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Administration of test foods for 4 weeks. / Wash out for 4 weeks. / Administration of placebo foods for 4 weeks.
Interventions/Control_2 Administration of placebo foods for 4 weeks. / Wash out for 4 weeks. / Administration of test foods 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
60 years-old >
Gender Male and Female
Key inclusion criteria 1.Healthy persons who are aged from 20 to 59 years.
Key exclusion criteria 1.Persons who are in treatment.
2.Persons who have medical history of cardiovascular disease.
3.Persons who have dysfunction of autonomic nervous system.
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-related food.
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 40

Research contact person
Name of lead principal investigator
1st name Shinichiro
Middle name
Last name Miyake
Organization Miyake Medical Institute Group
Division name Representative Director
Zip code 760-0017
Address 1-10-16 Banchou,Takamatsu,Kagawa 760-0017,Japan
TEL 087-831-2101
Email shin@miyake.or.jp

Public contact
Name of contact person
1st name Kei
Middle name
Last name Mizuno
Organization RIKEN Center for Biosystems Dynamics Research
Division name Laboratory for Pathophysiological and Health Science
Zip code 650-0047
Address 6-7-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
TEL 078-569-8868
Homepage URL
Email keimizuno@riken.jp

Sponsor
Institute Miyake Medical Institute Group
Institute
Department

Funding Source
Organization Kagawa Prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor RIKEN Center for Biosystems Dynamics Research
Name of secondary funder(s)

IRB Contact (For public release)
Organization Miyake Medical Institute Group
Address 1-10-16 Banchou,Takamatsu,Kagawa 760-0017,Japan
Tel miyazaki@miyake.or.jp
Email 087-831-2101

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 一般財団法人 三宅医学研究所(香川県)

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 40
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
2018 Year 09 Month 19 Day
Date of IRB
2018 Year 09 Month 19 Day
Anticipated trial start date
2018 Year 10 Month 15 Day
Last follow-up date
2019 Year 01 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 05 Day
Last modified on
2019 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039205

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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