UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051637 |
|---|---|
| Receipt number | R000058847 |
| Scientific Title | Effect of Test Food Consumption on Visual Function and Its Safety. |
| Date of disclosure of the study information | 2023/07/19 |
| Last modified on | 2024/02/22 15:12:20 |
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Basic information
Public title
Effect of Test Food Consumption on Visual Function and Its Safety.
Acronym
Effect of Test Food Consumption on Visual Function and Its Safety.
Scientific Title
Effect of Test Food Consumption on Visual Function and Its Safety.
Scientific Title:Acronym
Effect of Test Food Consumption on Visual Function and Its Safety.
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
* Visual function-related tests
･Color vision/contrast sensitivity test (1)
･Dynamic visual acuity test (1)
･Depth perception (2)
･Dark adaptation (2)
(1): Screening, Week 0, Week 8
(2): Week 0, Week 8
Key secondary outcomes
* Secondary indexes
1) Blood concentration of active ingredients. (1)
2) Visual Analogue Scale.(2)
3) The Japanese version of the Pittsburgh Sleep Quality Index. (1)
* Safety
1) Physical examination. (2)
･Blood pressure, pulsation.
･Weight, body fat percentage, BMI.
2) Biochemical test. (2)
･Hematologic test.
･Blood biochemical test.
･Urine analysis.
3) Doctor's questions / Adverse events. (2)
4) Subject's diary. (3)
* Other indexes
1) Baseline characteristics. (4)
2) Height measurement. (4)
3) Ophthalmic examination. (4)
･visual acuity.
･refraction test.
･dominant eye judgement.
･intraocular pressure measurement.
･fundus examination.
･slit-lamp microscopy.
(1): Week 0, Week 8
(2): Screening, Week 0, Week 8
(3): From the first day of ingestion of a test material to the last day of the test.
(4): Screening
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
Oral intake of the test food (1 pill in a day; 8 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 pill in a day; 8 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 20-64 years.
2) Individuals who are healthy and are not received treatment of disease.
3) Individuals who have binocular vision of 0.7 or better with naked eye or corrected vision, and who do not wear contact lenses.
4) Individuals whose written informed consent has been obtained.
5) Individuals who can come to the designated venue for this study and be inspected.
6) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1) Individuals using medical products.
2) Individuals with a history or present history of mental illness, sleep disorder, hypertension, diabetes, dyslipidemia, eye disease, or other serious illness.
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 whose BMI is over 30 kg/m2.
7) Individuals with drug and food allergies.
8) 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 lutein or 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.
9) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
10) Individuals with possible changes of life style during the test period.
11) Individuals who engage in a night work.
12) Individuals who are or are possibly pregnant, or are lactating.
13) Individuals who participated in other clinical studies in the past 3 months.
14) Individuals who are or whose family is engaged in healthy or functional foods.
15) Individuals judged inappropriate for the study by the principal.
Target sample size
60
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.clinic
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
+81-3-6240-1162
jimukyoku@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
| 2023 | Year | 07 | Month | 19 | 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
| 2023 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 18 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058847
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