Healthy Japanese subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Japanese 2. 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, hypotension, 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 herb or supplements with antihypertensive effects, or use antihypertensive drugs such as angiotensin-converting enzyme inhibitor 7. Subjects who use anticoagulant agent 8. Subjects who are allergic to medicines and/or the test food related products 9. Subjects who are pregnant, lactation, or planning to become pregnant during this trial 10. Subjects who suffer from COVID-19 11. 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 12. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin evaluation {gloss value, diffuse scattering correction, viscoelasticity, melanin, erythema, intensity, skin thickness, low echogenic band (LEB)}, wrinkle grade, savin scale, hair analysis (mean hair length, the percentage of anagen hairs, the percentage of telogen hairs, the density of vellus hair, the density of terminal hair, the ratio of vellus hair, the ratio of terminal hair), the age of skin, and skin health level at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| Body mass index, body fat percentage, lean body mass, muscle mass {right arm, left arm, right leg, left leg, and trunk (torso)}, fat mass {right arm, left arm, right leg, left leg, and trunk (torso)}, waist circumference, urolithin in the urine, and each item of an original questionnaire at 12w | — |
Countries
Japan
Contacts
ORTHOMEDICO Inc. R&D Department