Verification of impacts on brain activity, by test-food intake in a single dose
- Conditions
- Healthy male/female adults
- Registration Number
- JPRN-UMIN000049216
- 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) 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brain activity
- Secondary Outcome Measures
Name Time Method 1. Heartbeat 2. Psychological questionnaire 3. Skin temperature 4. Subjective vitality scale (Japanese ver.)