N/A (healthy adults)
Conditions
Interventions
Oral intake of the test food (1 time in a day, 12 weeks)
Oral intake of the placebo food (1 time in a day, 12 weeks)
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1]Females aged 20-59 years. [2]Individuals who are healthy and have no chronic physical disease including skin disease. [3]Individuals who are concerning on skin sagging and dullness. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can have an examination in a designated day. [6]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products. [2]Individuals who used or applied a drug for treatment of disease in the past 1 month. [3]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [4]Individual who have digestive organ disease. [5]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg. [6]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [7]Individuals with serious anemia. [8]Individuals who are sensitive to test product or other foods, and medical products. [9]Individuals who are or are possibly pregnant, or are lactating. [10]Individuals who have an addiction to alcohol or a mental illness. [11]Individuals who are a smoker. [12]Individuals whose bowel habit is irregular. [13]Individuals with possible changes of life style during the test period. [14]Individuals whose skin is sensitive or who is a chronic red face. [15]Individuals with skin disease, such as atopic dermatitis. [16]Individuals with probable seasonal allergy during the test period. [17]Individuals who are sensitive to cold. [18]Individuals who are busy to their own work, housework or child care and neglect skin care. [19]Individuals who cannot avoid daylight exposure during the test period. [20]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [21]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [22]Individuals who use cosmetics having a strong moisturizing effect or improving effect for wrinkle. [23]Individuals who had been conducted an operation on the test spot in the past 6months. [24]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [25]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Skin quality evaluation (Transepidermal water loss, skin moisture content, skin viscoelasticity, image analysis by VISIA, observation for skin condition by dermatologists), anti-glycation evaluation (Skin AGEs deposition, blood pentosidine), and vascular endothelial evaluation (acceleration pulse wave, arterial pressure-volume index, arterial velocity pulse index). (1) Week 0, Week 4, Week 8, Week 12 (image analysis of Visia will be held in Week 0 and Week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Safety [1]Blood pressure, pulsation (Week 0, Week 4, Week 8, Week 12) [2]Weight, body fat percentage, BMI (Week 0, Week 4, Week 8, Week 12) [3]Blood test (Week 0, Week 4, Week 8, Week 12) [4]Blood biochemical test (Week 0, Week 4, Week 8, Week 12) [5]Urine analysis (Week 0, Week 4, Week 8, Week 12) [6]Doctor's questions (Week 0, Week 4, Week 8, Week 12) *Other index [1]Subject's diary (From the first day of ingestion of a test material to the last day of the test) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed