None listed
Conditions
Interventions
Oral intake of the test food (2 tablets in a day
8 weeks).
Oral intake of the placebo food (2 tablets in a day
8 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women between 20 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 dry and flaky skin. 4) Individuals prone to constipation with defecation frequency of 3-5 times per week. 5) 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. 6) Individuals who can come to the designated venue for this study and be inspected. 7) Individuals 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. 5) who have a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc. 6) who are a patient or have a history of or endocrine disease. 7) with mental disabilities. 8) whose BMI is over 30 kg/m2. 9) who may develop allergic symptoms to the ingredients in the tested food, other foods, or medicines. 10) who have a habit of continuous intake of lactic acid bacteria-rich foods, natto bacteria-rich foods, health foods, or medicines at present or within the past 3 months. 11) who have a habit of continuously consuming medicines, foods for specified health uses, functional foods, or health foods that claim to improve skin at present or within the past 3 months. 12) who excessively take alcohol. 13) who are a smoker. 14) who engage in a night work. 15) with possible changes of life style during the test period. 16) 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. 17) who cannot intentionally refrain from being exposed to direct sunlight during the examination period, such as sunburns. 18) who neglect skin care. 19) Have a history of cosmetic procedures or treatments in the evaluation area 20) 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. 21) who habitually wash their bodies with strong stimulation to the evaluated area when taking a bath, etc. 22) who are or are possibly pregnant, or are lactating. 23) who participated in other clinical studies in the past 3 months. 24) judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transepidermal water loss | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes 1) Skin moisture content 2) Skin viscoelasticity 3) Observation for skin condition by dermatologists 4) Visual Analogue Scale * Exploratory endpoint 1) Specific blood test | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed