Healthy adults
Conditions
Interventions
Ingestion of plant-derived extract capsules for 8 weeks
Ingestion of placebo for 8 weeks
Sponsors
KAGOME CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i. Japanese participants ii. Male and female iii. Aged 20 years or older iv. In good health v. Individuals who are concerned about their skin elasticity
Exclusion criteria
Exclusion criteria: 1.Individuals under treatment for or with a history of malignant tumors, heart failure, or myocardial infarction. 2.Individuals with implanted devices such as pacemakers or defibrillators. 3.Individuals under treatment for chronic diseases: arrhythmia, hepatic disorders, chronic kidney disease, cerebrovascular disorders, rheumatic diseases, diabetes, dyslipidemia, hypertension, or other diseases. 4.Individuals under treatment or requiring treatment for other diseases. 5.Individuals with severe anemia. 6.Individuals with drug or food allergies. 7.Individuals with a history of alcohol or drug dependence. 8.Individuals using pharmaceuticals, quasi-drugs, or health foods that claim efficacy for skin health. 9.Individuals with chronic skin conditions such as atopic dermatitis. 10.Individuals with conditions affecting the skin at the evaluation sites. 11.Individuals regularly use skin care products other than basic cosmetics and sunscreen. 12.Individuals regularly receive skin treatments or use beauty devices. 13.Individuals who received cosmetic surgery or special skin treatments last 4 weeks or plan to during the study period. 14.Individuals who changed or started using basic cosmetics or sunscreen last 4 weeks. 15.Individuals who are exposed to excessive ultraviolet rays beyond daily life last 4 weeks or plan to during the study period. 16.Individuals taking hay fever medication. 17.Individuals consuming excessive alcohol. 18.Individuals who smoke or quit within 1 year prior to informed consent. 19.Individuals who plan to travel abroad or go on extended domestic business trips or vacations lasting one week or more during the study period. 20.Women who are pregnant, breastfeeding, or planning to become pregnant during the study period. 21.Individuals working night or rotating shifts. 22.Individuals who participated in another clinical trial last 4 weeks or plan to during the study period. 23.Individuals deemed unsuitable by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value of cheek R7 at 8 weeks after the start of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| a. The measured value of arm R7 at 8 weeks after the start of intervention b. Measured values at 8 weeks after the start of intervention for the following parameters: - Cheek skin elasticity (R0, R1, R2, R3, R4, R5, R6, R8, R9) - Arm skin elasticity (R0, R1, R2, R3, R4, R5, R6, R8, R9) - Blood flow in the cheek - Blood flow in the arm - Blood levels of nitric oxide metabolites (NOx) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO, Inc. R&D Department
Outcome results
None listed