Healthy male/female volunteers
Conditions
Interventions
Consumption of the test tablet to the volunteer, two drops a day for 4 weeks.
Consumption of the placebo tablet to the volunteer, two drops a day for 4 weeks.
Sponsors
Tokaigakuen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy Japanese volunteers belonging to the athletic clubs at Tokaigakuen university, ranging in age from 18 to 25 at informed consent. (2) Volunteers not being under some kind of continuous medical treatment, in spite of seasonal, chronic and unexpected. (3) Volunteers who gave informed consent to participate in this trial, after being provided with an explanation of the protocol detail. (4) Volunteers with a fixed blood pressure--a maximal blood pressure of less than 139 mmHg, a minimal blood one of less than 89 mmHg--judging from the average of two measured values. (5) Volunteers ranging in pulse rate from 40 to 100. (6) Volunteers ranging in body temperature from 35.5 to 37.0. (7) Volunteers having meals three times a day basically, without excessive eating and drinking. (8) Volunteers with appropriate contraception during this trial. (9) Volunteers who can understand the control matters, and observe them during this trial.
Exclusion criteria
Exclusion criteria: (1) Volunteers who have current medical history of digestive, hepatic, renal, cardiac or circulatory diseases, which would affect the absorption, distribution, metabolism and excretion of the test food. (2) Volunteers with previous history of a major operation for digestive diseases just like surgical removal/suture of the stomach and intestines (except having polyps removed, or appendectomy). (3) Volunteers with previous medical history of cerebral vascular disorders. (4) Volunteers having food allergy sensitive/specific to the test food. (5) Volunteers who are suspected of alcohol/drug dependence. (6) Volunteers who took part in the other clinical tests within 84 days before giving informed consent to participate in this trial. (7) Volunteers who donated 400 mL of their whole blood within the last 84 days before informed consent, or 200 mL of the blood within 28 days before the consent, or their blood component within 14 days before the consent. (8) Pregnant or lactating women. (9) Volunteers working on the night shift.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Hematological test value 2. Dietary condition survey 3. Physical condition 4. Height 5. Weight 6. Body mass index | — |
Countries
Japan
Contacts
Public ContactAtsuhisa Nishimura
Ichibiki CO., LTD. General manager
Outcome results
None listed