UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053971 |
|---|---|
| Receipt number | R000061571 |
| Scientific Title | A Randomized, Double-Blind, Parallel Group Study on the effect of test food intake on visual function. |
| Date of disclosure of the study information | 2024/03/27 |
| Last modified on | 2024/03/25 14:45:10 |
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Basic information
Public title
Effect of test food intake on visual function.
Acronym
Effect of test food intake on visual function.
Scientific Title
A Randomized, Double-Blind, Parallel Group Study on the effect of test food intake on visual function.
Scientific Title:Acronym
RCT on the effect of nutritional component intake on visual function.
Region
| Japan |
Condition
Condition
Healthy Subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of 6 weeks intake of the test food on visual function in adults aged 40 to 55 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional visual acuity
Key secondary outcomes
Contrast sensitivity
OCT tests (fundus)
The Quality of Vision (QoV) Questionnaire
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
Intake of test food for 6 weeks
Interventions/Control_2
Intake of placebo for 6 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
| 40 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Males and females aged 40-55 years.
(2) Make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Having serious ocular disease excluding refractive error.
(2) Spherical equivalent : -6.0D or less
(3) Cylinder is outside of +/- 1.50 D.
(4) Having a history of refractive surgery.
(5) Taking supplements* or medicines that contain vitamins or may affect eye function.
*Health foods, dietary supplements, Food for Specified Health Uses (FOSHU) or Foods with Nutrient Function Claims (FNFC)
(6) Smokers or have quit smoking within 3 months.
(7) Allergic to the ingredients of test food.
(8) Known or suspected to be pregnant.
(9) Using medical products.
(10) Having gastrointestinal disorders causing absorption deficiency.
(11) Participation in any clinical trial in the past 3 months.
(12) Judged as ineligible to participate by the physician.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Yamada |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Health Science Business Planning Division
Zip code
105-0022
Address
20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo
TEL
03-6832-6013
hsrpd@rohto.co.jp
Public contact
Name of contact person
| 1st name | Miwako |
| Middle name | |
| Last name | Shidomi |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Health Science Business Planning Division
Zip code
105-0022
Address
20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo
TEL
03-6832-6013
Homepage URL
hsrpd@rohto.co.jp
Sponsor or person
Institute
ROHTO Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical 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
Shiba Palace Clinic Ethics Review Committee
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
芝パレスクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061571
| 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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