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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024336
Receipt No. R000028022
Scientific Title A study for the effects of ingestion of food containing plant extract and lutein on visual function.:A randomized, double-blind, placebo controlled trial
Date of disclosure of the study information 2017/03/01
Last modified on 2017/10/07

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Basic information
Public title A study for the effects of ingestion of food containing plant extract and lutein on visual function.:A randomized, double-blind, placebo controlled trial
Acronym A study for the effects of ingestion of food containing plant extract and lutein on visual function.
Scientific Title A study for the effects of ingestion of food containing plant extract and lutein on visual function.:A randomized, double-blind, placebo controlled trial
Scientific Title:Acronym A study for the effects of ingestion of food containing plant extract and lutein on visual function.
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of ingestion of food containing plant extract and lutein on visual function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Near point of accommodation (NPA)
Evaluate at points of 4-week, 8-week and 12-week.
Key secondary outcomes Refractive power , best-corrected visual acuity, questionnaire

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 Food containing plant hishi extract and lutein, once a day for 12 weeks
Interventions/Control_2 Placebo without plant hishi extract and lutein, once a day for 12 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
40 years-old <=
Age-upper limit
55 years-old >=
Gender Male and Female
Key inclusion criteria (1) Men and women aged from 40 to 55.
(2) Subjects with subjective eye fatigue.
(3) A higher NPA at screening examination
Key exclusion criteria (1) Subjects who have amblyopia or strabismus.
(2) Subjects who are judged as presbyopia (the control width is less than 2.5 D for dominant eye).
(3) Subjects who have an uncorrected serious refractive error for dominant eye.
(4) Subjects who have undergone ophthalmic surgery for dominant eye.
(5) Subjects who have a serious eye disease or history of eye disease.
(6) Subjects who have a disease (e.g., pollinosis) which may influence the outcome of the study
(7) Subjects who have been taking health foods containing plant hishi extract, lutein, vitamin E for 3 months or expected to use during study.
(8) Subjects who have been taking health foods or medicines which may have effects to the amplitude of accommodation (including eye fatigue) for 3 months or expected to use during study
(9) Subjects who have been taking health foods or medicines which may have effects to the stiffness of shoulder and neck for 3 months or expected to use during study
(10) Subjects who cannot execute a display work load test
(11) Subjects who may have allergy to the test foods
(12) Subjects who have under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(13) Subjects who have under treatment of drug addiction and/or alcoholism
(14) Subjects who are participating other clinical studies or went back from an agreement acquisition day and participated in other clinical studies within 3 months or who are planning to participate other clinical studies during this study
(15) Subjects who are pregnant, breastfeeding, or planning to be pregnant or breastfeeding during study
(16) Subjects who are judged as unsuitable by doctor for laboratory value, anthropometric measurements, or physical examination value
(17) Subjects who are judged as unsuitable for lifestyle questionnaire
(18) Subjects who are judged as unsuitable by doctor for other reasons.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Futoshi Sakata
Organization SANTEN PHARMACEUTICAL CO., LTD.
Division name Sales & Marketing Division - OTC Products
Zip code
Address 1-13-7, Nihonbashi Muromachi, Chuo-ku, Tokyo
TEL 03-5299-8809
Email Futoshi.sakata@santen.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyasu Shimada
Organization TTC Co.,Ltd.
Division name Clinical Research Planning Department
Zip code
Address 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email h.shimada@ttc-tokyo.co.jp

Sponsor
Institute TTC Co.,Ltd.
Institute
Department

Funding Source
Organization SANTEN PHARMACEUTICAL 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 03 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 09 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 07 Day
Last modified on
2017 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028022

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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