UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053689 |
|---|---|
| Receipt number | R000061268 |
| Scientific Title | Research on the effects of continuous intake of research foods on the sensation of eye fatigue |
| Date of disclosure of the study information | 2024/02/23 |
| Last modified on | 2024/04/09 16:13:49 |
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Basic information
Public title
Research on the effects of continuous intake of research foods on the sensation of eye fatigue
Acronym
Research on the effects of continuous intake of research foods on the sensation of eye fatigue
Scientific Title
Research on the effects of continuous intake of research foods on the sensation of eye fatigue
Scientific Title:Acronym
Research on the effects of continuous intake of research foods on the sensation of eye fatigue
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of 2 weeks of continuous intake of research food A or research food B on the eye fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective symptom questionnaire, Dry Eye related Quality of life Score, Diary
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of 2 tablets of research food A once a day for 2 weeks
Interventions/Control_2
Continuous intake of 3 tablets of research food B once a day for 2 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
| 45 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 45 to 55 years of age
(2) Those who work VDT for 6 hours or more per day
(3) Those who feel eye fatigue due to VDT work
(4) Those who fully understand the purpose and content of the research and agree to participate in the research of their own free will
Key exclusion criteria
(1) Those who have eye diseases other than refractive error
(2) Those who may develop eye-related symptoms due to hay fever during the study period, or those who have perennial allergic conjunctivitis
(3) Those who have undergone LASIK surgery within the past 6 months
(4) Those with a history of or complications with serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, blood, or metabolic diseases
(5) Those who are currently undergoing some kind of medication treatment or outpatient treatment
(6) Those who are currently undergoing exercise or diet therapy under the supervision of a doctor
(7) Those who are using pharmaceuticals at the time of obtaining consent to participate in the study
(8) Those who regularly use foods with functional claims related to eye function, health foods, general pharmaceutical parts
(9) Those who cannot stop consuming foods or drinks that may affect the study (10) Those who use eye drops more than 4 days a week
(11) Those with a current or past history of drug or food allergies
(12) Those who have participated in another clinical study within the past month after obtaining consent to participate in the study
(13) Those who are pregnant, breastfeeding or wishing to become pregnant
(14) Those who are planning to travel overseas or have a long business trip during this study period
(15) Shift workers and late-night workers who work beyond 0:00 a.m.
(16) Those who regularly use foods with functional claims, foods with nutritional function claims, supplements, etc. that may affect the study
(17) Those who usually drink more than 40 g of pure alcohol per day
(18) Those who smoke
(19) Those who have donated component blood or collected 200 mL or more of whole blood between the month before the start of this study and the start of the study
(20) Those who are judged to be unsuitable as subjects based on the results of the preliminary examination
(21) Others who are judged to be unsuitable by the conducting physician in charge
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sachiyuki |
| Middle name | |
| Last name | Teramoto |
Organization
FANCL Corporation
Division name
Functional Food Research Institute, FANCL Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Yokohama Totsuka-ku, Kanagawa
TEL
045-820-3425
sateramoto@fancl.co.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Yamamoto |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center Foods Department Section 1
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-3023-8214
Homepage URL
yamamoto.keiji799@eps.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.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
メディカルステーションクリニック (Medical station clinic) (東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 11 | 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 | 02 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061268
| 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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| Registered date | File name |
