A Study of effect of a Single Ingestion of the Test Food on Autonomic Properties.
- Conditions
- o
- Registration Number
- JPRN-UMIN000047412
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Not provided
[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 or foods. [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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Heart rate measurements with my Beat. (Screening,Observation Period I,Observation Period II,Observation Period III,Observation Period IV.)
- Secondary Outcome Measures
Name Time Method *Secondary indexes [1] Mental questionnaire (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,Observation Period III,Observation Period IV. (2):Everyday from the day before the Observation Period I to the day before the Observation Period IV. (3):Screening