Validation of changes in autonomic nervous activity by a test-material consumptio
- Conditions
- Healthy male/female adults
- Registration Number
- JPRN-UMIN000049341
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Not provided
(1) Subjects being under some kind of continuous medical treatment. (2) Subjects who have periodically used health-specific / functional / health foods including supplements, which might affect the autonomic nervous system, metabolism and sleep. (3) Subjects with incompatible eyeballs/eyelashes for pupillometry. (4) Subjects with any hindrances to a pupil measurement (e.g., dry eye). (5) Subjects having a subjective symptom of claustrophobia and nyctophobia. (6) Subjects with nasal congestion and wrong judgement of fragrance. (7) Subjects with excessive alcohol intake (not less than 60 g/day/week). (8) Subjects with extremely irregular eating habits, and subjects having an irregular life rhythm with irregular shift work or midnight one. (9) At the moment of informed consent, subjects who are under other clinical trials with some kind of medicine/food, or partook in those within four weeks before this trial. (10) Subjects who are under a large stress condition with some kind of life event, such as house-moving, transfer, bereavement, etc., within three months before the agreement for this trial. (11) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (12) Subjects with a serious symptom of premenstrual syndrome at the moment of this trial. (13) Subjects who vaccinated within three days before this trial. (14) Pregnant, possibly pregnant, and lactating women. (15) Subjects having some kind of drug and/or food allergy. (16) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pupil measurement
- Secondary Outcome Measures
Name Time Method 1. Psychological questionnaire 2. Skin temperature