Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Capsule containing grapefruit extract Administration: Take one packet (containing 10 capsules) with water within 15 minutes after meal (either breakfast, lunch, or di
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. Subjects aged 20 or more and less than 65 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 use the following medicines: antihypertensive agent, antianginal agent, antiarrhythmic agent, antilipemic agent, antiulcer drug, antibiotic, trematode infection medication, antineoplastic agent, anti-anxiety agent, immunosuppressive agent, antiallergic drug, adrenocortical hormone, hypnotics and sedatives, anti-HIV agent, thyroid hormone, antimalarial agent, analgesic agent, antiplatelet agent, vasopressin receptor antagonist, drug to prevent gout attacks, or antiasthmatic 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 9. Subjects who suffer from COVID-19 10. 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 11. Subjects who are judged as ineligible to participate in this study by the physician 12. Subjects who recently changed their lifestyle 13. Subjects with an upset stomach
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of 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