Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Green coffee bean extract Administration: Take one bag per day. Please put the test food in a shaker with water and shake well before ingestion. The shaker will be se
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who smoke 21 or more cigarettes per day 10. Subjects whose daily alcohol intake exceeds 20 g {example of 20 g pure alcohol; 500 mL: beer or canned chu-hi (5% alcohol by volume), 180 mL: sake or wine (15% alcohol by volume), 110 mL: shochu (25% alcohol by volume), 60 mL: whiskey (40% alcohol by volume)} 11. Subjects whose sleeping time or habit is irregular due to work such as a late-night shift 12. Subjects who have irregular lifestyles (such as diet, exercise, and sleep) 13. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Subjects who experienced adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjects whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before consumption; Scr) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed