UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034391 |
|---|---|
| Receipt number | 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 13:53:53 |
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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
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
keimizuno@riken.jp
Sponsor or person
Institute
Miyake Medical Institute Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039205
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
