None listed
Conditions
Interventions
[1]Oral ingestion of a test food (1 time/200ml). [2]Observation. [3]Washout (over 6days) [4]Oral ingestion of a placebo food. (1 time/200ml). [5]Observation.
[1]Oral ingestion of a placebo food (1
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 in treatment for any 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 will develop seasonal allergy symptoms like hay fever or have allergic rhinitis during the test period. [11]Individuals who are or may be allergic to medical products. [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [13]Individuals whose diet is extremely irregular. [14] Individuals whose daily life rhythm is irregular for reasons such as shift work or late nights. [15] Individuals who have experienced significant stress due to life events within 3 months prior to obtaining informed consent. [16]Individuals who are participating with other clinical trial. [17]Individuals who cannot stop drinking from the day before the test. [18]Individuals who are or are possibly pregnant, or are lactating. [19]Individuals who have severe menstrual complaints (severe) and require medication. [20]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mental questionnaire(Observation Period I,Observation Period II) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1]Surface temperature and heart rate measurements with my Beat(1). [2]Taste questionnaire(1). *Safety indexes [1]Blood pressure,pulsation(1) [2]Weight,body fat percentage,BMI(1) [3]Doctor's questions(1) [4]Subject's diary(2) *Other indexes [1]Baseline characteristics(3) (1):Screening,Observation Period I,Observation Period II (2):Everyday from the day before the Observation Period I to the day before the Observation Period II. (3):Screening | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed