UMIN-CTR Clinical Trial

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
Email	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
Email	naoki.morishita@hb.nagase.co.jp

Sponsor
Institute	Hayashibara CO., LTD.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049763