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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020321
Receipt No. R000023468
Scientific Title An exploratory study to examine the health benefits of the continuous drink of olive tea: a randomized, parallel group, controlled trial.
Date of disclosure of the study information 2015/12/24
Last modified on 2019/05/10

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Basic information
Public title An exploratory study to examine the health benefits of the continuous drink of olive tea: a randomized, parallel group, controlled trial.
Acronym Continuous drink study of olive tea
Scientific Title An exploratory study to examine the health benefits of the continuous drink of olive tea: a randomized, parallel group, controlled trial.
Scientific Title:Acronym Continuous drink study of olive tea
Region
Japan

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

Objectives
Narrative objectives1 To examine the health benefits of the continuous drink of olive tea compared with green tea by an exploratory study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lipid metabolic indicator after 12-week intervention
Key secondary outcomes 1.Body weight, Abdominal circumference
2.Blood pressure
3.Glucose metabolic indicator
4.Hepatic and renal function indicator
5.Bone turnover marker

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Olive tea(1L/d*12 weeks)
Interventions/Control_2 Green tea(1L/d*12 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
40 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1)Aged 40 -70 years.
2)LDL-cholesterol not less than 120 mg/dL, under 160 mg/dL
3)Capable of giving informed consent
Key exclusion criteria 1)Body mass index not less than 30.0 kg/cm2
2)Fasting blood glucose not less than 126 mg/dL
3)HbA1c not less than 6.5%
4)Subjects who are received pharmacotherapy for alimentary disease
5)No enrollment in another interventional study
6)Subjects who were recognized unsuitable for this study by the Investigator.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Hashimoto
Organization University of Tsukuba, Faculty of Medicene
Division name Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3064
Email koichi.hashimoto@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Hashimoto
Organization University of Tsukuba, Faculty of Medicene
Division name Clinical research and regional innovation donated by the JA Ibaraki Public Welfare Federation
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3064
Homepage URL
Email koichi.hashimoto@md.tsukuba.ac.jp

Sponsor
Institute Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation
Fuculty of Medicine
University of Tsukuba
Institute
Department

Funding Source
Organization Yamahisa Co. Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Yamahisa Co.Ltd
University of Tsukuba, Faculty of Life and enviromental sciences
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 筑波大学附属病院(茨城県)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.4327/jsnfs.71.121
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
2015 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 30 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
2015 Year 12 Month 24 Day
Last modified on
2019 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023468

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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