UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027037
Receipt number R000030998
Scientific Title The influence of tea catechins on immune functions for elderly people: an exploratory study
Date of disclosure of the study information 2017/05/01
Last modified on 2017/11/24 13:53:46

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Basic information

Public title

The influence of tea catechins on immune functions for elderly people: an exploratory study

Acronym

The influences of tea catechins on immune functions

Scientific Title

The influence of tea catechins on immune functions for elderly people: an exploratory study

Scientific Title:Acronym

The influences of tea catechins on immune functions

Region

Japan


Condition

Condition

Healthy elderly people

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the influence of ingesting tea catechins on immune functions for healthy elderly people

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The change of biological laboratory data concerning immune functions 2 weeks after ingesting tea catechins

Key secondary outcomes

The change of the number of blood cells 2 weeks after ingesting tea catechins


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Tea catechins / 2 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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Written informed consent obtained before participation
2)Aged 65 years old or older
3)Able to orally ingest tea catechins 4)Able to prohibit intakes of other tea beverages or catechin rich diets during the study period
5)Able to prohibit new intakes of other dietary supplements influencing immune functions during the study period
6)Able to fill out questionnaires
7)Able to participate blood examinations at the start and end of the intervention

Key exclusion criteria

1)Having green tea allergy
2)Having severe immune deficiency or autoimmune disease
3)Taking drugs influencing immune functions(e.g. steroids, immunosuppressive agents and so on)
4)Taking dietary supplements influencing immune functions since long before the study
5)Subjects diagnosed by a physician inappropriate to participate in the study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Yamada

Organization

University of Shizuoka

Division name

School of Pharmaceutical Sciences

Zip code


Address

52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan

TEL

+81-54-264-5762

Email

hyamada@u-shizuoka-ken.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Yamada

Organization

University of Shizuoka

Division name

School of Pharmaceutical Sciences

Zip code


Address

52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan

TEL

+81-54-264-5762

Homepage URL

http://u-shizuoka-ken.ac.jp

Email

hyamada@u-shizuoka-ken.ac.jp


Sponsor or person

Institute

University of Shizuoka

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

静岡県立大学(静岡県)


Other administrative information

Date of disclosure of the study information

2017 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

2016 Year 12 Month 08 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 01 Day

Last follow-up date

2017 Year 06 Month 10 Day

Date of closure to data entry

2017 Year 07 Month 01 Day

Date trial data considered complete

2017 Year 08 Month 01 Day

Date analysis concluded

2017 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2017 Year 04 Month 18 Day

Last modified on

2017 Year 11 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030998


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name