None listed
Conditions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Males and females aged 20-34 years. [2] Individuals who are healthy and are not suffered from a chronic malady including skin disease. [3] Individuals whose BMI is less than 25.0kg/m2. [4] Individuals who are a non-smoker (no smoking in the last 1 year). [5] Individuals whose written informed consent has been obtained. [6] Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Individuals using medical products. [2] Individuals who use a drug and Chinese traditional medicine. [3] Individuals who receive a diet remedy and an exercise therapy under medical supervision. [4] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [5] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [6] Individuals who are a patient or have a history of or endocrine disease. [7] Individuals who use implantable medical devices such as a pacemaker. [8] Individuals who used a drug to treat a disease in the past 1 month. [9] Individuals who use regularly over-the-counter medicines, quasi-drugs, food for specified health uses, functional foods, health foods and other products that affect the autonomic nervous system, metabolism and sleep. [10] Individuals who with a history of brain or heart surgery [11] Individuals who will develop seasonal allergy symptoms like hay fever or have allergic rhinitis during the test period. [12] Individuals who are or may be allergic to medical products or foods. [13] Individuals who have allergies to tape or other problems with EEG and heart rate monitor attachment. [14] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [15] Individuals whose diet is extremely irregular. [16] Individuals whose daily life rhythm is irregular for reasons such as shift work or late nights. [17] Individuals who have experienced significant stress due to life events within 3 months prior to obtaining informed consent. [18] Individuals who are participating with other clinical trial. [19] Individuals who cannot stop drinking from the day before the test. [20] Individuals who are or are possibly pregnant, or are lactating. [21] Individuals who have severe menstrual complaints and require medication. [22] Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EEG Measurement (Observation Period I, Observation Period II.) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Heart rate measurements with my Beat. (1) [2] Mental questionnaire (1) *Safety indexes [1] Blood pressure, pulsation (1) [2] Weight, body fat percentage, BMI (2) [3] Doctor's questions (1) *Other indexes [1] Baseline characteristics (3) [2] height measurement (3) (1): Screening, Observation Period I, Observation Period II. (2): Screening, Observation Period I. (3): Screening. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed