Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Seaweed extract containing capsule Administration: Take one capsule of the test food per day * Daily dose should be taken within the day. If you forget to take t
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 40 or more and less than 65 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose FMD values are low (but 4% or more) at Scr
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. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 5. Subjects who daily take seaweed or products containing seaweed-derived components 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, breast-feeding, and planning to become pregnant 9. 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 10. Subjects who are smokers 11. Subjects who have been diagnosed with atopic dermatitis 12. Subjects who have used cosmetics that are not used in daily within the last 28 days before the agreement to participate in this trial 13. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 14. Subjects who have got cosmetic surgery 15. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of Flow Mediated Dilation (FMD) at eight weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change of FMD between at screening (before consumption: Scr) and 8w 2. The measured values and amount of change from Scr in each of the following items at 8w: maximum expansion width of vessel, diameter of vessels at rest, the standardized score of each cognitive function item (composite memory, neurocognition index, verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention and motor speed), moisture of the skin, transepidermal water loss, and viscoelasticity of skin | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed