Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Superba Boost(R) Administration: Participants will be instructed to take two oral capsules of 1000 mg Superba Boost(R) once per day at breakfast * If a dose is mis
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Hiroo Dermatology Clinic &
Mentors inc. Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese male and female 2. 30-65 years of age inclusive 3. Healthy individual (Be in general good health with no existing co-morbidities) 4. Individuals who are judged to be eligible for participation by the principal investigator 5. Have a Transepidermal Water Loss (TEWL) Score of their right inner forearm within the range of 15-30 g/m2/h inclusive at screening 6. Have a low habitual consumption of fatty fish (salmon, mackerel, herring and tuna) and food that is high in omega-3 fatty acid, defined as maximum frequency of once per week (Examples of food that is high in omega-3 fatty acid:Blue-backed fishes such as Atlantic mackerel, sardine, and mackerel pike, flaxseed oil, and fish oil) 7. Individuals who are neither overweight nor obese (BMI greater than or equal to 25)
Exclusion criteria
Exclusion criteria: 1. Be undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Be carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Be 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. Individuals who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily diet 5. Have been taking Omega-3 fatty acid supplement 3 months prior to the briefing session 6. Be taking long-term medication (s) (including western medicine such as antiallergic drugs, antihistamines, steroids, vasoconstrictors and Traditional Chinese Medicine) regularly) or supplement (s) 7. Individuals who are allergic to seafood, the test product and/or the test-food-related products in this trial 8. Have no intention of taking the test food with the prescribed amount and ingestion method 9. Individuals who are pregnant, lactating or planning pregnancy during the trial period 10. Participated in other clinical trial(s) 28 days prior to receiving agreement of this trial or planning to participate in other clinical trials during this trial period 11. Received cosmetic surgery in the past 12. Be receiving or undergoing skin medical treatment (e.g. laser treatment, face-lift), skincare treatment (e.g. beauty salon) or use skincare devices (e.g. facial massager) 13. Be diagnosed with atopic dermatitis 14. Be suffering from COVID-19 infection 15. Be deemed by the principal investigator to be unsuitable for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in TEWL on the right inner forearm, measured at week 0 (baseline) and week 12 after intervention using a TEWAMeter | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in TEWL on the right inner arm, measured at week 0 (baseline) and week 6 after intervention using a TEWAMeter 2. Changes in TEWL on the right inner arm, measured at week 6 after intervention and week 12 after intervention using a TEWAMeter 3. Change in skin hydration on the right inner forearm measured using a Corneometer ,from week 0 (baseline) to week 6 after intervention, and that from week 0 (baseline) to week 12 after intervention 4. Change in skin firmness (viscoelasticity) on the right inner forearm measured using a Cutometer from week 0 (baseline) to week 6 after intervention, and from week 0 (baseline) to week 12 after intervention 5. Change in subjective evaluation of skin symptoms by study participants, measured with a VAS scale and a Likert scale, from week 0 (baseline) to week 6 after intervention, and from week 0 (baseline) to week 12 after intervention 6. Change in Omega-3 index, using a blood spot collected by fingerpick measured from week 0 (baseline) to week 6 after intervention, and that from week 0 (baseline) to week 12 after intervention 7. Change in Microscopic examination; water/moisture comparison, Pores, Melanin/Freckles, Wrinkles, Porphyrin/sebum, Epidermis, from week 0 (baseline) to week 12 after intervention *Viscoelasticity is reflected by the ratio of degree of immediate retraction to that of the total skin deformation (R7) obtained from the graph produced when measuring with the Cutometer. This is also known as the portion of the elasticity compared to the complete curve. | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed