UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020321
Receipt number 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 11:10:41

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

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

Personal name



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

Value
https://center6.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