UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022244
Receipt number R000025628
Scientific Title An Open-label, Uncontrolled Study on Safety of Excessive Intake of Green Tea Containing Polyphenol
Date of disclosure of the study information 2016/05/09
Last modified on 2017/01/06 16:08:04

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Basic information

Public title

An Open-label, Uncontrolled Study on Safety of Excessive Intake of Green Tea Containing Polyphenol

Acronym

Safety of Excessive Intake of GreenTea Containing Polyphenol

Scientific Title

An Open-label, Uncontrolled Study on Safety of Excessive Intake of Green Tea Containing Polyphenol

Scientific Title:Acronym

Safety of Excessive Intake of GreenTea Containing Polyphenol

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To prove the safety of the green tea containing polyphenol in case of a dose 3 times higher than its recommended daily intake for 4 weeks.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The pattern, severity and frequency of side effects related to ingestion of the active test food during the administration period and the post administration period.

Key secondary outcomes

The pattern, severity and frequency of adverse events during the administration period and the post administration period, the body composition (BW, BFP and BMI) and blood lipids (TC, LDL-C, HDL-C, TG, NEFA and phospholipid)


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

Treatment

Type of intervention

Food

Interventions/Control_1

Daily ingestion of 4.0 g (green tea containing 100 mg of polyphenol)x 3 packs for 4 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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. Subjects who meet the following criterion either a, b or c
a. Subjects whose LDL-C is >=120 mg/dl and <160 mg/dl and BMI is >=18.5 kg/m2and <30.0 kg/m2.
b. Subjects whose LDL-C is >=70 mg/dl and <160 mg/dl and BMI is >=23.0 kg/m2 and <30.0 kg/m2.
c. Subjects whose LDL-C is >=70 mg/dl and <120 mg/dl and BMI is >=18.5 kg/m2 and <23.0 kg/m2.
2. Subjects who agree to participate in the current study with a written informed consent.

Key exclusion criteria

1.Subjects who are under physician&#39;s advice, treatment and/or medication for obesity, hyperlipidemia and diabetes.
2.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, disorder of endocrine and metabolism or affected with infectious diseases which are required to report to the authorities.
3.Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
4. Subjects with unusually high and/or low blood pressure or abnormal hematological data.
5. Subjects with serious anemia.
6. Pre- or post-menopausal women having obvious changes in physical condition.
7. Subjects who are at risk of having allergic reactions to drugs or foods (especially tea). 8. Subjects who have largely changed their dietary habits, physical activity habits and/or BW within the last 6 months.
9. Subjects with familial hypercholesterolemia.
10. Subjects who regularly take drugs, functional foods and/or supplements which would affect BW and BFP.
11. Subjects who regularly take drugs, functional foods and/or supplements which would affect the blood lipid levels.
12. Subjects who regularly take drugs, functional foods and/or supplements which would affect blood glucose.
13. Heavy smokers, alcohol addicts or subjects with irregular lifestyle.
14.Subjects who donated either 400ml whole blood within 12 weeks (men) /16 weeks (women) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
15. Pregnant or lactating women or women expect to be pregnant during the clinical trial.
16. Subjects who participated in other clinical trials within the last one month prior to this study.
17. Subjects who have participated in previous clinical trials of ingestion of the same active test food.
18. Any other medical reasons judged by the principal investigator.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.

Organization

Hokkaido Information University

Division name

Department of Medical Management and Informatics

Zip code


Address

59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan

TEL

011-385-4411

Email

nishihira@do-johodai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.

Organization

Hokkaido Information University

Division name

Center of Health Information Science

Zip code


Address

59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan

TEL

011-385-4430

Homepage URL


Email

nishihira@do-johodai.ac.jp


Sponsor or person

Institute

Hokkaido Information University

Institute

Department

Personal name



Funding Source

Organization

The Ethics Committee approves that the source of funding shall not be disclosed.

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

北海道情報大学 保健センター(北海道)


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 09 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


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 03 Month 31 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 10 Day

Last follow-up date

2016 Year 07 Month 21 Day

Date of closure to data entry

2016 Year 08 Month 25 Day

Date trial data considered complete

2016 Year 09 Month 01 Day

Date analysis concluded

2016 Year 12 Month 22 Day


Other

Other related information



Management information

Registered date

2016 Year 05 Month 09 Day

Last modified on

2017 Year 01 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025628


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name