N/A(healthy adults)
Conditions
Interventions
Oral ingestion of a test product containing glucosylceramide (10g per a day
12 weeks)
Oral ingestion of a placebo not containing glucosylceramide (10g per a day
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1]Japanese females aged 30-60 years [2]Individuals who are healthy and are not suffered from a chronic malady [3]Individuals who are anxious about skin dryness, sag, and tone [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 [3]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease [4]Individuals who contract or have a history of serious endocrine disease [5]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg [6]Individuals whose BMI is over 30 [7]Individuals with serious anemia [8]Individuals who are sensitive to a test product or other foods, and medical products [9]Individuals who are or are posslibly, or are lactating [10]Individuals who have addiction to alcohol [11]Individuals who have a habit of smoking [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [13]Individuals whose bowel habit is irregular [14]Individuals whose life style will change during the test period [15]Individuals whose skin is sensitive or who is chronically red-faced [16]Individuals with skin disease, such as atopic dermatitis [17]Individuals who would emerge seasonal allergay and use drugs (except eye drops and nose drops) [18]Individuals who is too sensitive to cold [19]Individuals who is busy to their own work, housework or child care and neglect skin care [20]Individuals who cannot avoid daylight exposure during the test period [21]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 months or will ingest those foods during the test period [22]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months [23]Individuals who use cosmetics having a strong moisturizing effect or improvintg effect for wrinkle [24]Individuals who had been conducted an operation on the test spot [25]Individuals who participated in other clinical studies in the past 3 months [26]Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Transepidermal water loss (Screening #1, Screening #2 & Week 0, Week 4, Week 8, Week 12) [2]Skin moisture content (Screening #1, Screening #2 & Week 0, Week 4, Week 8, Week 12) [3]Skin viscoelasticity (Screening #2 & Week 0, Week 4, Week 8, Week 12) [4]Visual evaluation (Screening #2 & Week 0, Week 4, Week 8, Week 12) [5]Questionnaire survey on skin condition (Screening #2 & Week 0, Week 4, Week 8, Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| [1]Blood pressure, pulsation (Screening #2 & Week 0, Week 4, Week 8, Week 12) [2]Weight, body fat percentage, BMI (Screening #2 & Week 0, Week 4, Week 8, Week 12) [3]Doctor's questions (Screening #2 & Week 0, Week 4, Week 8, Week 12) [4]Subject's diary(From the first day of ingestion of a test material to the last day of the test) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Department of Clinical Trial
Outcome results
None listed