N/A(healthy adaults)
Conditions
Interventions
Oral ingestion of the test food (8 weeks)
Oral ingestion of the placebo food A (8 weeks)
Oral ingestion of the placebo food B (8 weeks)
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese females aged 30-59 years. [2]Individuals who are healthy and are not suffered from a chronic malady including skin disease. [3]Individuals who are anxious about skin dryness. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can visit an inspection facility and be inspected in designated days. [6]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products. [2]Individuals who use a drug to treat a disease in the past 1 month. [3]Individuals with skin disease, such as atopic dermatitis. [4]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease. [5]Individuals who contract or have a history of serious endocrine disease. [6]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg. [7]Individuals whose BMI is over 30. [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [9]Individuals with serious anemia. [10]Individuals who are sensitive to a test producer other foods, and medical products. [11]Individuals who are or are possibly, or are lactating. [12]Individuals who are alcoholism or mental disorders. [13]Individuals who have a habit of smoking. [14]Individuals whose bowel habit is irregular. [15]Individuals whose life style will change during the test period. [16]Individuals with probable seasonal allergy, such as pollinosis, during the test period. [17]Individuals who will get sunburned during the test period (including winter sports like skiing and snowboarding). [18]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. [19] Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [20] Individuals who use cosmetics having a strong moisturizing effect or improving effect for wrinkle. [21]Individuals who had been conducted an operation on the test spot in the past 6months. [22]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [23]Individuals who are or whose family is engaged in healthy or functional foods. [24]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Transepidermal water loss (Screening, Week 0, Week 4, Week 8) [2]Skin moisture content (Screening, Week 0, Week 4, Week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Visual evaluation (Screening, Week 0, Week 4, Week 8) *Other index [1]Anti-Aging QOL Common Questionnaire (Screening, Week 0, Week 4, Week 8) *Safety evaluation [1]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 8) [2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 8) [3]Hematologic test (Screening, Week 0, Week 8) [4]Blood biochemical test (Screening, Week 8) [5]Blood test (Screening, Week 0, Week 8) [6]Urine analysis (Screening, Week 0, Week 8) [7]Doctor's questions (Screening, Week 0, Week 4, Week 8) [8]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