Healthy Japanese subjects
Conditions
Interventions
Duration: 4 weeks Test material: Tablet containing 100 mg of rose hip extract Dose: 5 tablets per day Administration: Chew five tablets after breakfast with water or lukewarm water, if necessary
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects who are between 18.5 kg/m2<= and <25 kg/m2 in BMI or between 25 kg/m2<= and <30 kg/m2 in BMI with <100 cm2 in the visceral fat area
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, glucose-6-phosphate dehydrogenase deficiency, sickle cell disease, hemochromatosis, thalassemia (Mediterranean anemia), or any other chronic diseases 4. Subjects who have disorder related to iron such as anemia 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 6. Subjects who are currently taking medications (including herbal medicines) and dietary supplements (health food) 7. Subjects who are an allergic reaction to medications and/or the test food related products 8. Subjects who are pregnant, breast-feeding, or planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who work late-night shift and the life-styles are irregular 11. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Physical examination 2. Urinalysis 3. Blood test 4. Subjective symptoms (the Likert scale) * Assess the measured value at screening (before consumption) and at 2 and 4 weeks after consumption and calculate the amount of change. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed