N/A(healthy adults)
Conditions
Interventions
Oral intake of the test food (1 stick / day
12 weeks).
Oral intake of the placebo (1 stick / day
12 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Healthy Japanese females aged 30-59 years. [2]Individuals who are healthy and have no chronic physical disease including skin disease. [3]Individuals who are aware of skin dryness. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can have an examination on a designated check day. [6]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products. [2]Individuals with skin disease, such as atopic dermatitis. [3]Individuals with strange skin conditions at measurement points. [4]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [6]Individuals who contract or have a history of serious gastrointestinal disease. [7]Individuals with serious anemia. [8]Individuals whose BMI is over 30.0. [9]Individuals who are sensitive to test product or other foods, and medical products. [10]Individuals who have a habit to ingest foods similar with the test product. [11]Individuals who had a habit to ingest health-promoting foods or supplements in the past 3 months or will ingest those foods during the test period. [12]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [13]Individuals who are or are possibly pregnant, or are lactating. [14]Individuals who take alcohol (expressed in an amount of alcohol: over 60mg/day). [15]Individuals who are patient or have a history of psychiatric disease. [16]Individuals who are a smoker. [17] Individuals with possible changes of life style during the test period. [18]Individuals who will develop seasonal allergy symptoms like hay fever and a drug. [19]Individuals who neglect skin care. [20]Individuals who cannot avoid daylight exposure during the test period. [21]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [22]Individuals who had been conducted an operation on the test spot. [23]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [24]Individuals who are or whose family is engaged in functional foods or cosmetics. [25]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Indexes for skin function (skin moisture content, transepidermal water loss) (Screening, Week 0, Week 8, Week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1]Observation for skin condition by dermatologists (Screening, Week 0, Week 8, Week 12). [2]Japanese Edition of Profile of Mood States (2nd edition) (Week 0, Week 8, Week 12). [3]Visual Analogue Scale (Week 0, Week 8, Week 12). *Safety [1]Blood test (Screening, Week 0, Week 12). [2]Blood biochemical test (Screening, Week 0, Week 12). [3]Urine analysis (Screening, Week 0, Week 12). [4]Blood pressure, pulsation (Screening, Week 0, Week 8, Week 12). [5]Weight, body fat percentage, BMI (Screening, Week 0, Week 8, Week 12). [6]Doctor's questions (Screening, Week 0, Week 8, Week 12). [7]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