None listed
Conditions
Interventions
[1] Single intake of the test food (1 package). [2] Observation. [3] Washout (2 weeks) [4] Non-intake of the test food. [5] Observation.
[1] Non-intake of the test food. [2] Observation. [3] Was
Sponsors
ROHTO Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Healthy Japanese males and females aged 30-59 years. [2] Individuals who are healthy and have no chronic physical disease. [3] Individuals whose constitution corresponds to the Flammer syndrome. [4] Individuals whose written informed consent has been obtained after explanation of this study. [5] Individuals who can have an examination on a designated check day [6] Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Individuals using medical products. [2] Individuals who have or have a medical history that could affect the outcome of the study. [3] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [4] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [5] Individuals who are a patient or have a history of or endocrine disease. [6] Individuals who have or have a history of eye diseases that may affect the results of the study. [7] Individuals whose spherical equivalent power is outside the range of -6.0 to +1.0 diopters. [8] Individuals whose intraocular pressure is over 21 mmHg. [9] Individuals who have a history of ophthalmic laser surgery or incision surgery. [10] Individuals whose BMI is over 30 kg/m2. [11] Individuals with drug and food allergies. [12] Individuals who use a drug to treat a disease in the past 1 month. [13] Individuals who currently or within the past 3 months have a habit of taking foods for specified health uses, foods with function claims, health foods, and supplements which affect affect blood pressure and blood flow, or plan to take them during the test period. [14] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). [15] Individuals with possible changes of life style during the test period. [16] Individuals who are likely to develop seasonal or perennial allergic symptoms during the study period and who may use pharmaceuticals (eye drops and nasal drops are acceptable). [17] Individuals who are a smoker. [18] Individuals who engage in a night work. [19] Individuals who are or are possibly pregnant, or are lactating. [20] Individuals who participated in other clinical studies in the past 3 months. [21] Individuals who are or whose family is engaged in healthy or functional foods. [22] Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fundus Blood Flow (optic nerve head) (Screening, Observation Period I, Observation Period II). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Fundus Blood Flow (choroid) (Screening, Observation Period I, Observation Period II). [2]Capillary evaluation by capillary scope (Screening, Observation Period I, Observation Period II). [3] Ocular perfusion pressure (Screening, Observation Period I, Observation Period II). *Safety [1] Doctor's questions (Screening, Observation Period I, Observation Period II). [2] Adverse events (Observation Period I, Observation Period II). [3] Subject's diary (From Observation Period I to the last day of the test). *Other indexes [1] Baseline characteristics (Screening). [2] Questionnaire survey with Flammer Syndrome Questionnaire (Screening). [3] Height measurement (Screening) [4] Weight,body fat percentage,BMI (Screening). [5] Blood pressure, pulsation. (Screening, Observation Period I, Observation Period II). [6] General ophthalmologic examination (visual acuity, intraocular pressure measurement, fundus examination, slit-lamp microscopy, dominant eye judgement, refraction test, Astigmatic power calculations [spherical equivalent power]., fundus photograph) (Screening). [7] Questionnaires at the end of the study (Observation Period I, Observation Period II). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed