N/A (healthy adults or adults with obese tendencies)
Conditions
Interventions
200 mg of a Koji extract, once-daily for 12 weeks
200 mg of placebo, not including the Koji extract, once-daily for 12 weeks
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Female aged from 30 to 49 years, when giving the informed consent. 2) Healthy individuals not having any chronic diseases or dermatoses. 3) Individuales who have dry skin and shallow wrinkles. 4) Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will. 5) Individuals who can accomplish their tasks in the study at the appointed date 6) Individuals who are judged suitable for this study by the investigator.
Exclusion criteria
Exclusion criteria: Individuals written in below, -who have some diseases with drug therapy, -who onsecutively receive medications for treatment of disease in the last 1 month, -who have severe disease histories in liver, kidney, heart, lung, blood or other tissues, -who have comorbidity or disease history in respiratory system, -whose systolic and diastolic blood pressures are over 160 mmHg and 100 mmHg, respectively, -who have donated over 200 or 400 mL of blood in the last 1 or 3 months, -who have severe anemia, -who could have some allergy to the test diet, foods or medicines, -who are pregnant, breastfeeding, or planning to be pregnant in the near future, -who are alcoholic or have mental disorder, -who have smoking habit, -who have irregular defecation, -who could change their life style during the study, -whose skin is extremely sensitive, or who have chronic ruddy complexion, outstanding pores or freckles, -who have some skin diseases such as atopic dermatitis, -who could have a seasonal allergy, -who have severe menopausal symptoms, -who have severe poor circulation, -who cannot care their skin enough, -who are willing to get sunburn, spend long time outdoors during the study, -who habitually intaked functional or healthy foods or supplements that could get skin condition better in the last 3 months, or who are planning to intake them during the study, -who habitually consume cosmetics or foods made of Koji, -who routinely used pharmaceuticals that could get skin condition better in the last 3 months, -who use cosmetics that could have strong effects on skin moisture or wrinkles, -who received a surgery on their faces or arms in the last 6 months, -who participated in other clinical trials in the last 3 months, -who and whose family work for a company manufacturing or selling healthy foods, functional foods or cosmetics, -who are judged unsuitable for this study by the investigator for other reasons,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <Efficacy> Transepidermal water loss, skin moisture, wrinkle topography, assessment of skin condition by a skin specialist, questionnaires about skin condition. <Safety> Blood pressure, pulse, body weight, body fat percentage, body mass index, hematology test, biochemical test, urinalysis, assessment of adverse events by a medical doctor. | — |
Secondary
| Measure | Time frame |
|---|---|
| <Efficacy> Color difference, melanin, erythema, image analysis of face skin by VISIA, texture of skin. | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd Department of Clinical Trial
Outcome results
None listed