N/A(healthy adults)
Conditions
Interventions
Oral ingestion of a test food (2 packs once a day for 4 weeks)
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1]Healthy Japanese females aged 30-59 years. [2]Individuals who are aware of skin dryness. [3]Individuals with a tendency for constipation (at 3-4 times of defecation per week). [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 whose dietary pattern is irregular. [2]Individuals who intake a food containing lactic acid bacterium over 4 days in a week. [3]Individuals using medical products. [4]Individuals who intake laxatives, antiflatulent etc. aiming to improve bowel movements. [5]Individuals who take medicine in the past 1 month to remedy disease. [6]Individuals who take antibiotics in the past 1 month. [7]Individuals with skin disease, such as atopic dermatitis. [8]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease. [9]Individual who have or had digestive organ disease. [10]Individuals whose BMI is over 30. [11]Individuals who are sensitive to test product or other foods, and medical products. [12]Individuals who are or are possibly pregnant, or are lactating. [13]Individuals who are alcohol dependent or have other mental disabilities. [14]Individuals who are smoker. [15]Individuals with possible changes of life style, such as working a night shift, during the test period. [16]Individuals who will develop seasonal allergy symptoms like hay fever. [17]Individuals who will get sunburned during the test period. [18]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. [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 have received a cosmetic medicine. [22]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [23]Individuals who cannot collect fecal samples in their own house and submit them to the designated organization. [24]Individuals who are or whose family is engaged in healthy or functional foods. [25]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Skin quality evaluation (Transepidermal water loss, skin moisture content, skin viscoelasticity, image analysis by VISIA, observation for skin condition by dermatologists)(1) and indexes for evaluating defecation and intestinal flora (analysis of intestinal flora, organic acid analysis, putrefaction products, ammonia analysis, the Japanese Version of the Constipation Assessment Scale [middle term], Bristol stool scale, bowel diary) (2), (3),(4) (1)Transepidermal water loss, skin moisture content, skin viscoelasticity, image analysis by VISIA, observation for skin condition by dermatologists (Week 0, Week 4) (2)analysis of intestinal flora, organic acid analysis, putrefaction products, ammonia analysis (Week 0, Week 4) (3) the Japanese Version of the Constipation Assessment Scale [middle term], Bristol stool scale (Week 0, home survey, Week 4) (4)Bowel diary (from the first day of ingestion of a test material to the last day of the test) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcome [1]Questionnaire of physical feeling (Week 0, home survey, Week 4) *Safety [1]Doctor's questions (Week 0, Week 4) *Other index [1]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