None listed
Conditions
Interventions
Oral intake of the test product (1 bottle in a day
12 weeks).
Oral intake of the placebo product (1 bottle in a day
12 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1] Healthy Japanese females aged 40-59 years. [2] Individuals who are healthy and have no chronic physical disease including skin disease. [3] Individuals who are aware of dry, flaky or dull skin. [4] Individuals whose written informed consent has been obtained after explanation of this study. [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 strange skin conditions at measurement points. [3] Individuals who have wounds or inflammation in the evaluation site. [4] Individuals who used a drug to treat a disease in the past 1 month. [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 kg/m2. [9] Individuals who are sensitive to test product or other foods, and medical products. [10] Individuals who have a habit to ingest special health food, food with functional claims, health-promoting foods, beauty health drink or supplements claiming to improve skin condition and Anti-glycation in the past 3 months or will ingest those foods during the test period. [11] Individuals who have a habit to ingest or use health-promoting foods, or supplements containing similar composition with a test food in the past 3 months or will ingest those foods during the test period. [12] Individuals who are or are possibly pregnant, or are lactating. [13] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [14] Individuals who are patient or have a history of psychiatric disease. [15] Individuals who are a smoker. [16] Individuals who engage in a night work. [17] Individuals with possible changes of life style during the test period. [18] Individuals who will develop seasonal allergy symptoms like hay fever and be to suffer from worsening eyes and nose symptoms or use anti-allergic drugs during the test period. [19] Individuals who neglect skin care. [20] Individuals who had been conducted an operation or beauty treatment on the test spot. [21] Individuals who participated in other clinical studies in the past 3 months. [22] Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin viscoelasticity (Week 0, Week 6, Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Transepidermal water loss(1) [2] Skin moisture content(1) [3] Color-difference(1) [4] Image analysis by VISIA(2) [5] Skin AGEs measurement(1) [6] Observation for skin condition by dermatologists(1) [7] Plasma pentosidine(2) [8] Anti-Aging QOL Common Questionnaire(2) [9] Visual Analogue Scale(1) *Safety [1] Blood pressure, pulsation(2) [2] Weight, body fat percentage, BMI(2) [3] Doctor's questions(1) [4] Adverse events: number of cases and expression rate of adverse events(3) [5] Subject's diary(4) *Other indexes [1] Baseline characteristics(5) [2] Height measurement(5) (1): Week 0, Week 6, Week 12 (2): Week 0, Week 12 (3): Week 6, Week 12 (4): From the first day of ingestion of a test material to the last day of the test (5): Week 0 | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed