None listed
Conditions
Interventions
12 weeks).
Oral intake of the placebo product (1 packet in a day
12 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Japanese males and females aged 30-59 years. [2] Individuals who are healthy and have no chronic physical disease including skin disease. [3] Individuals who are aware of dry, flaky, and sagging skin. [4] Individuals whose written informed consent has been obtained after explanation of this study. [5] Individuals who can have an examination on a designated check day. [6] Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Individuals using medical products. [2] Individuals with skin disease, such as atopic dermatitis. [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 of serious hepatopathy, kidney damage, heart disease and hematological disease. [6] Individuals who contract or have a history of serious gastrointestinal 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 have a habit of continuously taking foods containing foods related to the test foods, dietary fiber-enriched foods, foods for specified health uses that claim skin improvement effects, foods with function claims, health foods, and supplements currently, or within the past 3 months, and who plan to take them during the test period. [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 are or are possibly pregnant, or are lactating. [13] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [14] Individuals who are patient or have a history of psychiatric disease. [15] Individuals who are a smoker. [16] Individuals who engage in a night work. [17] Individuals with possible changes of life style during the test period. [18] Individuals who are likely to develop seasonal or perennial allergic symptoms during the study period and who may use pharmaceuticals. [19] Individuals who neglect skin care. [20] Individuals who had been conducted an operation or beauty treatment on the test spot. [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 |
|---|---|
| [1] Indexes for skin function [2] Skin Questionnaire [3] QOL Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| *Safety [1] Blood pressure, pulsation [2] Doctor's questions [3] Adverse events: number of cases and expression rate of adverse events [4] Subject's diary | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed