UMIN-CTR Clinical Trial

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
Last 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
1st 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