Healthy Japanese
Conditions
Interventions
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 so
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Toujinkai, Nishi-Arai Ekimae Clinic Ophthalmology and Orthopedics Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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- | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed