None listed
Conditions
Interventions
12 weeks).
Oral intake of the placebo food (2 capsules in a day
12 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women between 35 and 64 years of age at the time of obtaining consent to participate in the study. 2) Individuals who are healthy and have no chronic physical disease including skin disease. 3) Individuals who are aware of skin deterioration such as firmness and sagging. 4) Individuals 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) 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 undergoing hormone replacement procedures. 3) Individuals with strange skin conditions at measurement points. 4) Individuals who used a drug to treat a disease in the past 1 month. 5) Individuals who have a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc. 6) Individuals who are a patient or have a history of or endocrine disease. 7) Individuals with mental disabilities. 8) Individuals whose BMI is over 30 kg/m2. 9) Individuals who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug. 10) Currently, or within the past 3 months, those who have or will take medicines or health foods with claims of skin improvement or anti-glycation effects on a regular basis during the study period. 11) Individuals who excessively take alcohol. 12) Individuals who are a smoker. 13) Individuals who engage in a night work. 14) Individuals with possible changes of life style during the test period. 15) Individuals 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. In addition, persons who may be taking anti-allergy medication or nasal drops. 16) Individuals who cannot intentionally refrain from being exposed to direct sunlight during the examination period, such as sunburns. 17) Individuals who neglect skin care. 18) Have a history of cosmetic procedures or treatments in the evaluation area 19) Individuals with scars or inflammation at the evaluation site, or those who feel that skin irritation affecting the examination occurs at the evaluation site before or after menstruation. 20) Individuals who are or are possibly pregnant, or are lactating. 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 |
|---|---|
| Skin viscoelasticity (Week 0, Week 6, Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1]Terminal glycation product measurement(1) [2]Transepidermal water loss(1) [3]Skin moisture content(1) [4]Image analysis by VISIA(2) [5]Observation for skin condition by dermatologists(1) [6]Visual Analogue Scale(1) * Exploratory endpoint [1]Specific blood test(2) *Safety [1]Blood pressure, pulsation(1) [2]Weight, body fat percentage, BMI(1) [3]Hematologic test(1) [4]Blood biochemical test(1) [5]Urine analysis(1) [6]Doctor's questions(1) [7]Side effects/ Adverse events(3) [8]Subject's diary(4) (1):Week 0, Week 6, Week 12 (2):Week 0, Week 12 (3):Week 6, Week 12 (4):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