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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035766
Receipt No. 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 2019/02/04

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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
Last 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
Email ke-yui@fancl.co.jp

Public contact
1st 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
Email matsuoka@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2019 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 04 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
2019 Year 02 Month 04 Day
Last modified on
2019 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040717

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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