UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055761 |
|---|---|
| Receipt number | R000063725 |
| Scientific Title | Effects of consumption of the test food on eye fatigue in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/10/07 |
| Last modified on | 2025/01/17 10:17:25 |
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Basic information
Public title
Effects of consumption of the test food on eye fatigue in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
Effects of consumption of the test food on eye fatigue in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title
Effects of consumption of the test food on eye fatigue in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on eye fatigue in healthy Japanese
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on eye fatigue in healthy Japanese.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. High frequency component-1 (HFC-1) at 12 weeks after intervention (12w) [Pre and post visual display terminals workload (VDT load): The change from pre to post VDT load] (Measured value)
Key secondary outcomes
1.HFC-1 at 12w [Pre and post VDT load] (Change and percentage (%) change from screening (before intervention; Scr))
2.HFC-1 at 12w [Pre VDT load, post VDT load] (Measured value, change and %-change from Scr)
3."Sleepiness on rising," "initiation and maintenance of sleep," "frequent dreaming," "refreshing," "sleep length," and each item in the OSA sleep inventory MA version at 12w (Measured value, changes and %-changes from Scr)
4.Defecation frequency, number of days with defecation, and amount of defecation in period 2~13* (Measured value, changes and %-changes from period 1*)
*Period 1: 7 days prior to Scr
Period 2~13: Periods separated by 7 days from the start of intervention
5.Individuals whose stool shape, stool smell, and exhilarating feeling of defecation improved by >=1 scales in period 2~13 compared to period 1
6."Fatigue," "hand coldness," and "foot coldness" in the subjective symptoms questionnaire (visual analogue scale; VAS) at 12w (Measured value, changes and %-changes from Scr)
7."Shoulder stiffness," "neck stiffness," "eye dryness," and "concentration" in the subjective symptom questionnaire (VAS) at 12w, [Pre and post VDT load, pre VDT load, post VDT load] (Measured value, changes and %-changes from Scr)
8."Stress of VDT" in the subjective symptom questionnaire (VAS) at 12w (Measured value, and the changes and %-changes from Scr)
9.Individuals who response to each scale of "I'm concerned about the return odor after consuming the test products" in the subjective symptoms questionnaire (Likert scale) at 12w
10.Individuals whose response of "I'm concerned about halitosis" or "My skin is acting up" in the subjective symptom questionnaire (Likert scale) improved by >=1 scales from Scr to 12w
11.Total cholesterol (Cho), high density lipoprotein-Cho, low density lipoprotein-Cho, and triglyceride at 12w (Measured value, changes and %-changes from Scr)
12.Systolic and diastolic blood pressure at 12w (Measured value, changes and %-changes from Scr)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Capsule containing fermented black garlic
Administration: Take three capsules per day with water after breakfast.
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: 12 weeks
Test food: Capsule not containing fermented black garlic
Administration: Take three capsules per day with water after breakfast.
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals who feel eye fatigue when performing VDT operation
6. Individuals whose lower value between the "naked eye monocular acuity" and the "corrected monocular acuity" (average of both eyes) is 1.0 or higher
7. Individuals whose HFC-1 value after the VDT workload minus the value before the VDT workload is relatively high at Scr
Key exclusion criteria
Individuals who
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. are currently undergoing treatment for hemorrhagic disease, stomach disorder, indigestion, hypotension, and insomnia
5. plan to undergo surgery between two weeks prior to the agreement to participate in this study and two weeks posterior to completion of consumption
6. are allergic to sulfa drugs
7. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
8. are taking or using medications (including herbal medicines) and supplements
9. are allergic to medicines and foods related to the test products including garlic
10. are pregnant, lactating, or planning to become pregnant during this study
11. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
12. are diagnosed with presbyopia, or have presbyopia in self-knowledge
13. have eye disease, entropion or trichiasis
14. apply eye drops for eye diseases
15. have ametropia and have not been properly corrected
16. have undergone ophthalmic surgery including laser in situ keratomileusis surgery
17. have excessive astigmatism
18. have irregular sleeping time or habit due to work such as a late-night shift
19. have nocturia two times or more
20. have irregular lifestyles (such as inconstant eating time, insufficient sleeping time)
21. drink to excess every day (average of more than about 20 g/day as absolute alcohol intake)
22. are judged as ineligible to participate in this study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yamada |
Organization
Medical Corporation Toujinkai, Nishi-Arai Ekimae Clinic Ophthalmology and Orthopedics
Division name
Director
Zip code
123-0843
Address
2F Nakazato Bldg., 2-3-13, Nishi-arai sakae-cho, Adachi-ku, Tokyo, Japan
TEL
03-5681-1133
dr_yamada@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
ASK INTERCITY CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Toujinkai, Nishi-Arai Ekimae Clinic Ophthalmology and Orthopedics
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-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
医療法人社団濤仁会 西新井駅前クリニック眼科整形外科 (東京都)
Medical Corporation Toujinkai, Nishi-Arai Ekimae Clinic Ophthalmology and Orthopedics (Tokyo, Japan)
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 07 | 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
68
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 | 09 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 04 | 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 | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063725
