N/A(healthy adults)
Conditions
Interventions
Oral intake of the Test Food A (one bottle [50 m]
eight weeks).
Oral intake of the Test Food B (one bottle [50 m]
eight weeks).
Oral intake of the Placebo Food (one bottle [50 m]
eight weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Healthy Japanese males and 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 sag and dryness. [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 skin disease, such as atopic dermatitis. [3]Individuals with strange skin conditions at measurement points. [4]Individuals who use or used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [5]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [6]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [7]Individuals who contract or have a history of serious gastrointestinal disease. [8]Individuals with serious anemia. [9]Individuals whose BMI is over 30 kg/m2. [10]Individuals who are sensitive to test product or other foods, and medical products. [11]Individuals who have a habit to ingest 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 with possible changes of life style during the test period. [17]Individuals who will develop seasonal allergy symptoms like hay fever and use a drug. [18]individuals who neglect skin care. [19]Individuals who will get sunburned during the test period. [20]Individuals who had been conducted an operation or beauty treatment on the test spot in the past 6 months. [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 |
|---|---|
| [1]Skin viscoelasticity (Week 0, Week 4, Week 8). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Transepidermal water loss (Week 0, Week 4, Week 8). [2]Skin moisture content (Week 0, Week 4, Week 8). [3]Observation for skin condition by dermatologists (Week 0, Week 4, Week 8). [4]Visual Analogue Scale (Week 0, Week 4, Week 8). *Safety [1]Weight, body fat percentage, BMI (Week 0, Week 4, Week 8). [2]Blood pressure, pulsation (Week 0, Week 4, Week 8). [3]Doctor's questions (Week 0, Week 4, Week 8). [4]Adverse events: number of cases and expression rate of adverse events (Week 4, Week 8). [5]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