UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045803 |
|---|---|
| Receipt number | R000049763 |
| Scientific Title | Evaluation of the effect of HBF2020-05 intake on visual function. |
| Date of disclosure of the study information | 2021/10/20 |
| Last modified on | 2022/04/20 17:12:24 |
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Basic information
Public title
Evaluation of the effect of HBF2020-05 intake on visual function.
Acronym
Evaluation of the effect of HBF2020-05 intake on visual function.
Scientific Title
Evaluation of the effect of HBF2020-05 intake on visual function.
Scientific Title:Acronym
Evaluation of the effect of HBF2020-05 intake on visual function.
Region
| Japan |
Condition
Condition
Healthy Japanease adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of HBF2020-05 intake on visual function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual function at 0, 1, 2, and 3 months of test food intake
Key secondary outcomes
Questionnaire survey at 0, 1, 2, and 3 months of test food intake
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
Oral ingestion of HBF2020-05 once a day for 3 months
Interventions/Control_2
Oral ingestion of the placebo control food once a day for 3 months
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Full-time, part-time, or contract employees of Hayashibara who have been with the company for at least one year and are in good health and are between the ages of 20 and 64, and in the case of fixed-term employees, whose contract includes the test period.
2) Those who are able to come to the Fujisaki, Fujita, or Head Office areas for various measurements.
3) Those who have difficulty reading letters within 30cm of their eyes while not struggling to see far.
4) Those who do not wear bifocal glasses.
5) Those who do not work in shifts for the convenience of subject management.
6) Those who are not pregnant or may become pregnant, those who wish to become pregnant during the study period, and those who are not breast-feeding.
7) Those who have no history of eye diseases (glaucoma, cataract, etc.), surgery (including LASIK surgery), or medication.
8) In addition to 7), have no history of renal or hepatic disease, cardiac disease, respiratory disease, endocrine disease, or other metabolic disease, surgery, or medication.
9) If you are taking any supplements on a regular basis, please stop taking them during the study period.
Key exclusion criteria
None in particular
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Morishita |
Organization
Hayashibara CO., LTD.
Division name
R&D Division, Development Unit
Zip code
7028006
Address
675-1, Fujisaki, Naka-ku, Okayama
TEL
0862763141
naoki.morishita@hb.nagase.co.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Morishita |
Organization
Hayashibara CO., LTD.
Division name
R&D Division, Development Unit
Zip code
7028006
Address
675-1, Fujisaki, Naka-ku, Okayama
TEL
0862763141
Homepage URL
naoki.morishita@hb.nagase.co.jp
Sponsor or person
Institute
Hayashibara CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Hayashibara Co., Ltd.
Address
675-1, Fujisaki, Naka-ku, Okayama
Tel
086-276-3141
HB96301@hb.nagase.co.jp
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
株式会社林原（岡山県）/Hayashibara CO.,LTD. (Okayama)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 20 | 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
32
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
| 2021 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049763
