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
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
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
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
