None listed
Conditions
Interventions
Oral intake of the test food (Once a day
8 weeks).
Oral intake of the placebo food (Once a day
8 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals 1) Men and women between 30 and 64 years of age at the time of obtaining consent to participate in the study. 2) who are healthy and have no chronic physical disease including skin disease. 3) with dry or flaky skin 4) who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing. 5) who can come to the designated venue for this study and be inspected. 6) judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: Individuals 1) using medical products. 2) undergoing hormone replacement procedures. 3) with strange skin conditions at measurement points. 4) who used a drug to treat a disease in the past 1 month (excluding those who have taken drugs for headache, menstrual cramps, common cold, etc.). 5) who have a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc. 6) with co-morbidities and serious history of gastrointestinal conditions. 7) with mental disabilities. 8) whose BMI is over 30 kg/m2. 9) who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug. 10) who are currently, or within the past 3 months have been, in the habit of continuously consuming pharmaceuticals, foods for specified health uses, foods with functional claims, or health foods that claim to improve skin, or who plan to do so during the study period. 11) who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). 12) who are a smoker. 13) who engage in a night work. 14) with possible changes of life style during the test period. 15) who may experience symptoms such as itching at the evaluation site due to the onset of seasonal allergic symptoms such as hay fever during the study period, and individuals who may take anti-allergy medication or use nasal drops (eye drops are acceptable). 16) who cannot intentionally refrain from being exposed to direct sunlight during the examination period, such as sunburns. 17) who neglect skin care. 18) Man shaving his beard with a razor blade. 19) with a history of cosmetic procedures or treatments in the evaluation area. 20) with wounds or inflammation at the site of evaluation 21) who are or are possibly pregnant, or are lactating. 22) who participated in other clinical studies in the past 3 months. 23) judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transepidermal water loss (Week 0, Week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes 1) Skin moisture content (1) 2) Observation for skin condition by dermatologists (1) 3) Visual Analogue Scale (1) *Safety 1) Blood pressure, pulsation (1) 2) Weight, body fat percentage, BMI (1) 3) Doctor's questions (1) 4) Side effects/ Adverse events (2) 5) Subject's diary (3) (1): Week 0, Week 8 (2): Week 8 (3): 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