UMIN-CTR Clinical Trial

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
Last 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
1st 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