UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036462
Receipt number R000040909
Scientific Title Study on effects of functional mixed fermented tea leaf powder made from unripe orange fruits and green tea leaves on blood pressure(2)
Date of disclosure of the study information 2019/05/01
Last modified on 2019/10/10 14:41:15

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Basic information

Public title

Study on effects of functional mixed fermented tea leaf powder made from unripe orange fruits and green tea leaves on blood pressure(2)

Acronym

Study on effects of fermented tea leaf powder made from unripe orange fruits and green tea leaves on blood pressure(2)

Scientific Title

Study on effects of functional mixed fermented tea leaf powder made from unripe orange fruits and green tea leaves on blood pressure(2)

Scientific Title:Acronym

Study on effects of fermented tea leaf powder made from unripe orange fruits and green tea leaves on blood pressure(2)

Region

Japan


Condition

Condition

high blood pressure

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of long-tern ingestion of fermented tea leaf powder on suppression of high blood pressure.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

blood pressure

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

The subjects ingested the placebo meal for twelve weeks.

Interventions/Control_2

The subjects ingested the active meal for twelve 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

20 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

1)Healthy male and female between 20 and 70 years old
2)Individuals whose systolic blood pressure is 130 or more and 159 or less, or diastolic blood pressure is 85 or more and 99 or less
3) Individuals who can refrain from drinking and eating during the test period
4) Individuals who understand the purpose and contents of the experiment

Key exclusion criteria

1)Individuals taking drugs, supplements and healthy foods which affect the blood pressure
2)Those who can not stop taking supplements or health foods that may affect blood pressure during the test period
3)Subjects who are contracting kidney and/or liver diseases
4)Those who have been diagnosed with Familial hypertension
5)Individuals with a chronic diseases
6)Person who donated more than 400 ml of blood within 3 months prior to the study
7)Those who can not stop taking a large amount of green tea or black tea during the test period
8)Pregnant women, or women with intending to become pregnant, and lactating woman
9)Individuals participating or intending to participate in a drug administration test
10)Individuals judged by the doctor to be unsuitable

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kazunari
Middle name
Last name Tanaka

Organization

Univercity of Nagasaki

Division name

Faculty of Nursing and Nutrition

Zip code

851-2195

Address

1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195

TEL

0958135216

Email

katanaka@sun.ac.jp


Public contact

Name of contact person

1st name Hideki
Middle name
Last name Ito

Organization

Univercity of Nagasaki

Division name

Regional Partnership Center

Zip code

851-2195

Address

1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195

TEL

0958135216

Homepage URL


Email

katanaka@sun.ac.jp


Sponsor or person

Institute

Univercity of Nagasaki

Institute

Department

Personal name



Funding Source

Organization

charle 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

Univercity of Nagasaki

Address

1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195

Tel

0958135216

Email

katanaka@sun.ac.jp


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

2019 Year 05 Month 01 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

2019 Year 03 Month 01 Day

Date of IRB

2019 Year 04 Month 01 Day

Anticipated trial start date

2019 Year 03 Month 01 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 04 Month 10 Day

Last modified on

2019 Year 10 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040909


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name