healthy person
Conditions
Interventions
GroupA(placebo-rest-100mg-rest-300 mg) 5weeks.
GroupB(300mg-rest-100mg-rest-placebo) 5weeks.
Sponsors
Clinical Creative Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age: 35 to 50 years old (at the time of obtaining consent) 2) Gender: Male 3) Inpatient/Outpatient: Outpatient 4) Healthy subjects (In this study, healthy subjects are defined as those who do not have any serious organ disorder or specific disease, who are not receiving any related treatment, and who are not receiving any medication. 5) Systolic blood pressure is 101.5 mg/kg. 5) Systolic blood pressure between 101 mmHg and 139 mmHg, and diastolic blood pressure between 61 mmHg and 89 mmHg 6) Patients who can consume the test food for three 7-day periods (21 days) (including a 2-week rest period) 7) Patients whose diet or exercise regimen, if any, will not be changed during the study period 8)Those who can give written consent. 9)Those whose daily work is mainly office work (desk work) and who are married.
Exclusion criteria
Exclusion criteria: 1) Those who are taking medication that may affect the test results. 2) Those who may show allergic symptoms to the test foods. 3) Those who have participated in other clinical trials within one month prior to obtaining consent, or those who are currently participating in other clinical trials. 4) Patients with serious diseases [heart failure, myocardial infarction, myocarditis, etc.] (however, this does not apply to patients with pacemakers or other devices that are judged not to affect the study), liver diseases [liver failure symptoms (fulminant hepatitis), liver cirrhosis, liver tumors], renal diseases [nephrotic syndrome, renal failure (acute and chronic), uremia, hydronephrosis], etc., and those who have problems with their general condition 5) Patients with severe anemia 6) Patients who, in the judgment of the study investigator or sub-investigator, are judged to be at increased risk to subjects or for whom there is a possibility of insufficient data being obtained by conducting the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Health concept assessment (health-related QOL measurement) 2.Uchida-Kreperin test index (work efficiency, percentage of correct answers) 3.Salivary amylase 4.Salivary cortisol 5.Heart rate variability (LF/HF ratio: by testing device) | — |
Countries
Japan
Contacts
Public ContactKazuhiro Ohno
CLINICAL CREATIVE CO,LTD Pharmaceutical Development Division
Outcome results
None listed