UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028736 |
|---|---|
| Receipt number | R000032884 |
| Scientific Title | The randomized duble blind parallel-group comparison test of the effect for eye function of the Bilberry extract and Lutein |
| Date of disclosure of the study information | 2017/08/21 |
| Last modified on | 2018/08/20 09:28:06 |
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Basic information
Public title
The randomized duble blind parallel-group comparison test of the effect for eye function of the Bilberry extract and Lutein
Acronym
The randomized duble blind parallel-group comparison test of the effect for eye function of the Bilberry extract and Lutein
Scientific Title
The randomized duble blind parallel-group comparison test of the effect for eye function of the Bilberry extract and Lutein
Scientific Title:Acronym
The randomized duble blind parallel-group comparison test of the effect for eye function of the Bilberry extract and Lutein
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficiency for eye function of the foods including bilberry extract and Lutein
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Near-reflex: intake 0,12 weeks
Key secondary outcomes
Contrast sensitivity: intake 0, 12 weeks
MPOD: intake 0, 12 weeks
Blood lutein concentration: intake 0, 12 weeks
Subjective symptoms: intake 0,12 weeks
Safety(blood test, urinary test, history taking):intake 0, 12 weeks
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Bilberry extract 120mg/day, Lutein 6mg/day, 12weeks
Interventions/Control_2
Placebo, 12weeks
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1, Healthy Japanese male and female
2, Aged=>20 years, <60 years
3, BMI =>25kg/m2
4, Subjects who feel eyestrain
5, Subjects who routinely carries out personal computer (PC) work or driving a car
6, Subjects who have not undergone LASIK.
7, Visual acuity with the naked eyes is 0.1 or more
8, Subjects who do not conscious of presbyopia
9, Subjects who can stop eye drops during the test period
Key exclusion criteria
1, Subjects who have previous medical history of serious diseases (e.g., cancer, cardiac arrest, cardiac infarct).
2, Subjects who have previous medical history and/or current medical history of serious diseases(e.g., arrhythmia, liver disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, other chronic diseases)
3, Subjects who have undergone gastrointestinal tract surgery; except appendectomy.
4, Subjects who take medicines.
5, Subjects who have an eye disease.
6, Subjects who are allergic to medicines or the test material of this trial.
7, Subjects who are or are possibly pregnant, or are lactating.
8, Subjects who participate in other clinical trials in the past 3 months.
9, Subjects who work time is irregular.
10, Smoker
11, Subjects who have been determined ineligible by principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Katsuta |
Organization
REFRE Co.,Ltd.
Division name
President
Zip code
Address
1-7-28, Naka-cho, Ageo-city, Saitama
TEL
048-774-4011
toru-katsuta@hc-refre.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Marie Kosehira |
Organization
Omnica Co.,Ltd
Division name
Research and development Dept.
Zip code
Address
TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5840-9811
Homepage URL
kosehira@omnica.co.jp
Sponsor or person
Institute
Omnica Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
REFRE 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
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 | 08 | Month | 21 | 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 | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 21 | 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
| 2017 | Year | 08 | Month | 18 | Day |
Last modified on
| 2018 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032884
