Healthy male/female adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Healthy male/female subjects ranging in age from 20 to 34, at informed consent. (2) Subjects having less than 25.0 kg/m2 of BMI. (3) Subjects with no smoking (not less than one year). (4) Subjects who can give informed consent to take part in this trial, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects being under some kind of continuous medical treatment, including the test period. (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 chest (e.g., thick bodyhair, pacemaker-fitting) for heartbeat measurements. (4) Subjects with excessive alcohol intake (not less than 60 g/day/week). (5) Subjects with extremely irregular eating habits, and subjects having an irregular life rhythm with irregular shift work or midnight one. (6) At the moment of informed consent, subjects who are under the other clinical tests with some kind of medicine/food, or participated in those within four weeks after the current trial, or are planning to join those after the consent. (7) 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 and during the test period. (8) Subjects with any difficulty in giving up drinking since the day before the scheduled date of this trial. (9) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (10) Subjects getting excessive exercise every day. (11) Subjects with a serious symptom of premenstrual syndrome. (12) Subjects having any difficulty in touching alcoholic drinks constitutionally. (13) Pregnant, possibly pregnant, and lactating women. (14) Subjects having some kind of drug and/or food allergy. (15) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heartbeat | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Psychological questionnaire 2. Flavor-evaluating questionnaire 3. Body surface temperature | — |
Countries
Japan
Contacts
CPCC Company Limited Clinical Planning Department