UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048895 |
|---|---|
| Receipt number | R000055614 |
| Scientific Title | Effect of Test Food Consumption on Visual Function. |
| Date of disclosure of the study information | 2022/09/10 |
| Last modified on | 2023/08/03 11:38:18 |
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Basic information
Public title
Effect of Test Food Consumption on Visual Function.
Acronym
Effect of Test Food Consumption on Visual Function.
Scientific Title
Effect of Test Food Consumption on Visual Function.
Scientific Title:Acronym
Effect of Test Food Consumption on Visual Function.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effect of test food consumption on visual function and its safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Schirmer's test (1)
(1): Screening , Observation Period I , Observation Period II .
Key secondary outcomes
*Secondary indexes
[1] Visual Analogue Scale (1)
[2] Tear film break-up time (2)
*Safety
[1] Blood pressure, pulsation (2)
[2] Weight, body fat percentage, BMI (2)
[3] Doctor's questions (2)
[4] Subject's diary (3)
*Other index
[1] Baseline characteristics (4)
[2] Height measurement (4)
[3] Hematologic test (4)
[4] Blood biochemical test (4)
[5] Urine analysis (4)
[6] General ophthalmologic examination (visual acuity, intraocular pressure measurement, fundus examination, slit-lamp microscopy, dominant eye judgement, refraction test) (4)
(1): Observation Period I, Observation Period II.
(2): Screening, Observation Period I, Observation Period II.
(3): Everyday from the starting day of Test Period I to the last day of the study.
(4): Screening.
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
[1] Oral ingestion of a test food (1 tablet in a day; 2 weeks).
[2] Observation.
[3] Washout (2 weeks)
[4] Oral ingestion of a placebo food (1 tablet in a day; 2 weeks).
[5] Observation.
Interventions/Control_2
[1] Oral ingestion of a placebo food (1 tablet in a day; 2 weeks).
[2] Observation.
[3] Washout (2 weeks)
[4] Oral ingestion of a test food (1 tablet in a day; 2 weeks).
[5] Observation.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1] Males and females aged 20-64 years.
[2] Individuals who are healthy and have no chronic physical disease.
[3] Individuals who are aware of eye fatigue due to daily VDT work or / and eye strain from driving a car.
[4] Individuals who engage in VDT work in their everyday life for 20 hours or more per week and 5 days per week (including time spent playing video games and operating computers and cell phones).
[5] Individuals who have binocular vision of 1.0 or better with naked eye or corrected vision, and who do not wear contact lenses, or are able to change to glasses during the examination period. [6] Individuals whose written informed consent has been obtained.
[7] Individuals who can come to the designated venue for this study and be inspected.
[8] Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1] Individuals using medical products.
[2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[4] Individuals who are a patient or have a history of or endocrine disease.
[5] Individuals who used a drug to treat a disease in the past 1 month.
[6] Individuals who use artificial tears more than 6 times a day in everyday life.
[7] Individuals who have been diagnosed with presbyopia or are aware of presbyopia.
[8] Individuals with eye diseases, entropion, or trichiasis.
[9] Individuals with a confirmed diagnosis of dry eye.
[10] Individuals who are using eye drops for the treatment of ocular diseases.
[11] Individuals who have refractive errors and have not been properly corrected.
[12] Individuals who have undergone LASIK vision restoration surgery.
[13] Individuals with high intensity astigmatism.
[14] Individuals whose eye fatigue is thought to be caused by a neurological disorder or other regulatory dysfunction.
[15] Individuals whose BMI is over 30kg/m2
[16] Individuals with drug and food allergies.
[17] Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements which claim to improve eye-related functions or contain active ingredients that are expected to have an effect on the eyes in the past 3 months or will ingest those foods during the test period.
[18] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[19] Individuals who may change their lifestyle during the examination period.
[20] Individuals who engage in a night work.
[21] Individuals who are or are possibly pregnant, or are lactating.
[22] Individuals who participated in other clinical studies in the past 3 months.
[23] Individuals judged inappropriate for the study by the principal.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinc
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Omnica 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81528382485
i.takahashi@tes-h.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 10 | 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
| 2022 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 09 | Day |
Last modified on
| 2023 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055614
