None listed
Conditions
Interventions
[1] Oral ingestion of a test food (2 tablets in a day
2 weeks). [2] Observation. [3] Washout (2weeks). [4] Oral ingestion of a placebo food (2 tablets in a day
2 weeks). [5] Observation.
[1] Oral ingestion of a placebo food (2 tablets in a day
2 weeks). [2] Observation. [3] Washout (2weeks). [4] Oral ingestion of a test food (2 tablets in a day
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: 1) Individuals using medical products. 2) Individuals with a history or current condition of serious disorders affecting the eyes, digestive organs, liver, kidneys, heart, lungs, blood, or mental health. 3) Individuals who used a drug to treat a disease in the past 1 month. 4) Individuals who use intraocular lens. 5) Individuals with presbyopia or age-related farsightedness who use reading glasses. 6) Individuals whose BMI is over 30 kg/m2. 7) Individuals with drug and food allergies. 8) Individuals who currently have, or have had within the past three months, a habit of regularly consuming functional foods, health foods, or supplements that claim to improve eye-related functions, or that contain maqui berry, bilberry, blackcurrant, anthocyanin, or other active ingredients expected to have beneficial effects on the eyes; as well as individuals who plan to consume such products during the trial 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 who are unable to follow instructions from the study supervisor or who judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Visual Function Assessment Due to VDT Load(1) (1):Screening, Observation Period I, Observation Period II. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary Evaluation Items 1) Pharmacokinetics of blood anthocyanin concentration following a single dose of the test food. (1) *Safety Evaluation Items 1) Blood pressure, pulsation. (2) 2) Weight, body fat percentage, BMI. (2) 3) Doctor's questions / Adverse events. (2) 4) Daily activity log. (3) (1):Observation Period I, Observation Period II. (2):Screening, Observation Period I, Observation Period II. (3):From Observation Period I to the last day of the test. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed