UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of tea catechins on immune functions for elderly people: an exploratory study
Title of the study (Brief title)	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	Hiroshi Yamada
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
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	Hiroshi Yamada
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
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
Institute	University of Shizuoka
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030998