Validation of effects on blood flow, mental stress and sleep quality by using a test additive
- Conditions
- Healthy male/female adults
- Registration Number
- JPRN-UMIN000047429
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
(1) Subjects who take steadily in the health-specific/functional/supplementary/health foods which might affect this trial, and will have any difficulty in giving up taking them after the consent. (2) Subjects who have taken affecting medicines, and have any difficulty in refraining from taking them during this trial. (3) Subjects having an irregular life rhythm with irregular shift work or midnight one. (4) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (5) Pregnant, possibly pregnant, and lactating women. (6) Subjects having the possibility of unconsciousness induced by arrhythmia, hypertension, orthostatic hypotension, sleep-apnea syndrome, or epileptic/hypoglycemic fit. (7) Subjects with some kind of skin symptom, just like an itch and a rash, by using a bath additive. (8) Subjects who are under other clinical trials with some kind of medicine/food, or participated in those within the last four weeks before this trial, or are planning to join those after the consent. (9) Subjects who donated their blood components and/or whole blood (200 mL) within a month to this trial. (10) Males who donated their whole blood (400 mL) within the last three months to this trial. (11) Females who donated their whole blood (400 mL) within the last four months to this trial. (12) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (13) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (14) 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
- Secondary Outcome Measures
Name Time Method