None listed
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Individuals 1)Women between 30 and 59 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)who are aware of dry and sagging skin. 4)with spontaneous defecation frequency of 3-4 times per week. 5)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. 6)who can come to the designated venue for this study and be inspected. 7)judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: Individuals 1)using medical products. 2)who have been diagnosed and are being treated for functional constipation at a medical institution 3)who are determined to have chronic constipation in the diagnostic criteria for chronic constipation. 4)undergoing hormone replacement procedures. 5)with strange skin conditions at measurement points. 6)who used a drug to treat a disease in the past 1 month. 7)who have a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc. 8)who are a patient or have a history of or endocrine disease. 9)with mental disabilities. 10)whose BMI is over 30 kg/m2. 11)who may develop allergic symptoms to any of the ingredients in the test food, or who may develop allergic symptoms to any other food or drug. 12)who have a habit of continuous use of foods, foods for specified health uses, foods with functional claims, or health foods that claim to improve skin and bowel movements at present or within the past 3 months that may affect the results of the study. 13)with a current or history of continuous use of food products that may affect the test results within the past 3 months. 14)who excessively take alcohol. 15)who are a smoker. 16)who engage in a night work. 17)with irregular lifestyle or eating habits, and who may change their lifestyle during the examination period. 18)who may develop hay fever or other seasonal allergic symptoms during the study period and may use pharmaceutical medication or nasal drops. 19)who cannot intentionally refrain from being exposed to direct sunlight during the examination period, such as sunburns. 20)who neglect skin care. 21)with wounds or inflammation at the site of evaluation 22)with a history of cosmetic procedures or treatments in the evaluation area. 23)who are or are possibly pregnant, or are lactating. 24)who participated in other clinical studies in the past 3 months. 25)judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indexes for skin function (Week 0, Week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes 1) Observation for skin condition by dermatologists (1) 2) Sensitivity index (1) 3) Intestinal Environment-Related Indices Intestinal Microflora Analysis (1) Diary of bowel movements (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 (2) (1):Week 0, Week 8 (2):Everyday From the seven days before the first day of ingestion of a test material to the last day of the test. (3):Week 8 | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed