UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035766 |
|---|---|
| Receipt number | R000040717 |
| Scientific Title | Effect of the supplement on accommodation of the eye in middle- and old-aged adults: A randomized, double blinded, placebo controlled, and parallel group comparison study. |
| Date of disclosure of the study information | 2019/02/04 |
| Last modified on | 2020/02/04 10:12:19 |
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Basic information
Public title
Effect of the supplement on accommodation of the eye in middle- and old-aged adults: A randomized, double blinded, placebo controlled, and parallel group comparison study.
Acronym
Effect of the supplement on accommodation of the eye in middle- and old-aged adults
Scientific Title
Effect of the supplement on accommodation of the eye in middle- and old-aged adults: A randomized, double blinded, placebo controlled, and parallel group comparison study.
Scientific Title:Acronym
Effect of the supplement on accommodation of the eye in middle- and old-aged adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the supplement on accommodation of the eye in middle- and old-aged adults after administration of the supplement for 4 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accommodation of the eye
Key secondary outcomes
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
Ingestion of the test food for 4 weeks
Interventions/Control_2
Ingestion of the placebo for 4 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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese male and female aged 35 to 65 years old at the time of the informed consent.
2. Subject who has no eye diseases other than refractive error (dysregulation).
3. Subject whose naked vision for each eye is more than 0.2.
4. Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria
1. Subject who is taking medication or under medical treatment.
2. Subject who is under exercise therapy or dietetic therapy.
3. Subject who has an allergy for test food.
4. Subject who has or had a history of either medicine or alcohol dependence syndrome.
5. Subject who has or had a history of mental illness (depression) or sleep disturbance.
6. Subject who is on a night-shift or is a shift worker.
7. Subject whose lifestyle is extremely irregular.
8. Subject who has an unbalanced diet.
9. Subject who has or had a history of disease in liver, kidney, cardiovascular system, gastrointestinal, lung, blood or metabolic function.
10. Subject who has or had a history of eye disease (Not include minor eye diseases).
11. Subject who can stop taking any kind of health food, supplement or medicine other than the test foods during the current study.
12. Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
13. Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition.
14. Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
15. Subject who can't keep the daily records.
16. Subject who is judged as an inappropriate candidate according to the screening data.
17. Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3755
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Matsuoka |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Round Cross Tamachi. 10th Fl., 5-31-19 Shiba,Minato-ku,108-0014,Japan
TEL
03-3431-1260
Homepage URL
matsuoka@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
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
医療社団法人 幸野メディカルクリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 04 | 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
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 04 | Day |
Last modified on
| 2020 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040717
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
