UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020767
Receipt number R000023970
Scientific Title Safety Evaluation of Long-term Intake of Powdered Tea in adult male and female.
Date of disclosure of the study information 2016/01/27
Last modified on 2018/09/05 13:26:31

* 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

Safety Evaluation of Long-term Intake of Powdered Tea in adult male and female.

Acronym

Safety Evaluation of Long-term Intake of Powdered Tea in adult male and female.

Scientific Title

Safety Evaluation of Long-term Intake of Powdered Tea in adult male and female.

Scientific Title:Acronym

Safety Evaluation of Long-term Intake of Powdered Tea in adult male and female.

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of long term intake of powdered tea for 12 weeks.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hematologic test
Blood biochemistry test
Urine test
Blood pressure/pulsation
Weight/body mass index
Medical Interview
Adverse event

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Consumption of powdered tea, quantity of recommended daily intake, for 12 weeks

Interventions/Control_2


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

64 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Males and females from 20 to 64 years of age
2) Subjects falling under any of the following
A. fasting blood glucose levels are less than 110 mg/dL or 2-hour glucose levels in 75 g OGTT are less than 140 mg/dL (about 10 subjects)
B. fasting blood glucose levels are ranged 110 to 125 mg/dL or 2-hour glucose levels in 75 g OGTT are ranged 140 to 199 mg/dL (about 10 subjects)

Key exclusion criteria

(1) Subjects having a current or past history of serious diseases such as diabetes, hepatic or renal disorder, or cardiovascular disease
(2) Subjects having possibilities for emerging allergy related to the study
(3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(5) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(6) Subjects who intend to become pregnant or lactating
(7) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(8) Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuto Yoshida

Organization

YAKULT HONSHA CO., LTD

Division name

Yakult Central Institute

Zip code


Address

5-11, Izumi, Kunitachi-shi, Tokyo, Japan

TEL

042-577-8960

Email

yasuto-yoshida@yakult.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinsuke Tsuji

Organization

TTC CO., LTD.

Division name

Clinical Research Planning Department

Zip code


Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

s.tsuji@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC CO., LTD.

Institute

Department

Personal name



Funding Source

Organization

YAKULT HONSHA CO., LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 27 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


Results

17 adverse events occurred in 10 out of 22 subjects, but the degree of symptoms was all mild, and relevance to research food was "None", judged by the responsible doctor.
In the clinical laboratory test values of individual subjects, inspection items that were out of the reference range were found, but it was judged that they are transient minor fluctuations and not clinically problematic fluctuations.
In addition, items with significant changes in average values of clinical laboratory test values and measured values compared to before intake were found, but in both cases there are minor fluctuations and it is not a clinically problematic fluctuation It was judged by the responsible doctor.
Based on the above results, it was shown that there is no problem on the safety during long-term ingestion of the research food "powdered tea drink" under this research condition.

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

2016 Year 01 Month 14 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 28 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

2016 Year 01 Month 27 Day

Last modified on

2018 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023970


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name