None listed
Conditions
Interventions
8 weeks).
Oral intake of the placebo food (1 bottle in a day
8 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females aged 35-59 years at the time of obtaining consent to participate in the study. 2) Individuals who are healthy and have no chronic physical disease including skin disorder. 3) Individuals who are concerned about dry or flaky skin. 4) Individuals whose written informed consent has been obtained. 5) Individuals who can come to the designated venue for this study and be inspected. 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 and hematological disease. 6)Individuals who are a patient or have a history of or endocrine 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 habitually take the foods for specified health uses (FOSHU) or functional food. 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 excessively take alcohol. 13)Individuals who are patient or have a history of psychiatric disease. 14)Individuals who are a smoker. 15)Individuals who engage in work such as sales or delivery, and who spend long time in outdoor activities and exposure to ultraviolet rays in their daily lives. 16)Individuals who engage in a night work. 17)Individuals with possible changes of lifestyle 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 will get sunburned during the test period. 21)Individuals who had been conducted an operation or beauty treatment on the evaluation area within 6 months before the start of the test. 22)Individuals who are pregnant, lactating, or who may become pregnant during the test period. 23)Individuals who participated in other clinical studies in the past 3 months. 24)Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indexes of skin function and intestinal environment. (Week 0, Week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcome 1) Observation for skin condition by dermatologists (1) 2) Putrefactive metabolites in blood (1) 3) Fecal organic acid (1) *Sensory index 1) Visual Analogue Scale (1) *Eating trend index 1) Dietary survey with Brief-type Self-Administered Diet History Questionnaire (BDHQ) (1) * Safety indexes 1) Blood pressure, pulsation (1) 2) Weight, body fat percentage, BMI (1) 3) Doctor's questions, Side effects and adverse events (1) 4) Subject's diary (2) (1): Week 0, Week 8 (2): 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