Healthy male/female adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Male/female volunteers ranging in age from 20 to 34 at informed consent. (2) Volunteers having less than 25.0 kg/m2 of BMI. (3) Volunteers with no smoking (not less than a year). (4) Volunteers who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Volunteers being under some kind of continuous medical treatment, including the test period. (2) Volunteers who have periodically used health-specific / functional / health foods including supplements, which might affect the autonomic nervous system, metabolism and sleep. (3) Volunteers with incompatible chest (e.g., thick bodyhair, pacemaker-fitting) for heartbeat measurements. (4) Volunteers with excessive alcohol intake (not less than 60 g/day/week). (5) Volunteers with extremely irregular eating habits, and volunteers having an irregular life rhythm with irregular shift work or midnight one. (6) At the moment of informed consent, volunteers who are under other clinical tests with some kind of medicine/food, or partook in those within four weeks before the current study, or are planning to take part in those after the consent. (7) Volunteers 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 study and during the test period. (8) Volunteers with any difficulty in giving up drinking since the day before the scheduled date of this study. (9) Volunteers with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (10) Volunteers getting excessive exercise every day. (11) Volunteers with a serious symptom of premenstrual syndrome. (12) Volunteers who have been determined as poor blood circulation, according to the doctor's oral questions at the moment of informed consent. (13) Volunteers planning to vaccinate within three days before this study. (14) Pregnant, possibly pregnant, and lactating women. (15) Volunteers having some kind of drug and/or food allergy. (16) Volunteers who break out in a rash from putting electrodes on the head and chest. (17) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain activity | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Heartbeat 2. Psychological questionnaire 3. Skin temperature 4. Subjective vitality scale (Japanese ver.) | — |
Countries
Japan
Contacts
CPCC Company Limited Clinical Planning Department