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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028220
Receipt No. R000032302
Scientific Title Exploratory test on oxidative stress in tears by intake of lutein coffee
Date of disclosure of the study information 2017/07/13
Last modified on 2017/10/18

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Basic information
Public title Exploratory test on oxidative stress in tears by intake of lutein coffee
Acronym Exploratory test on oxidative stress in tears by intake of lutein coffee
Scientific Title Exploratory test on oxidative stress in tears by intake of lutein coffee
Scientific Title:Acronym Exploratory test on oxidative stress in tears by intake of lutein coffee
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Measure changes in oxidative stress in tears by intake of lutein coffee.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 8-OHdG
Key secondary outcomes Total protein, Schirmer Test, mucin

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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake of lutein coffee 3 cups a day for 8 consecutive 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
70 years-old >
Gender Male and Female
Key inclusion criteria 1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese who is 20 years old or more and under 70 years old
Key exclusion criteria 1.Persons who have chronic illness and are receiving medication
2.Persons who are allergic to the test food
3.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
4.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
5.Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohito Ishikawa
Organization Healthcare Systems Co., Ltd.
Division name Research and Development
Zip code
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Email ishikawa@hc-sys.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohito Ishikawa
Organization Healthcare Systems Co., Ltd.
Division name Research and Development
Zip code
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Homepage URL
Email ishikawa@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization Menicon Nect 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
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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 13 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
2017 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 13 Day
Last follow-up date
2017 Year 09 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 13 Day
Last modified on
2017 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032302

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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