None listed
Conditions
Interventions
Single use of test product (2 sets of 8 minutes sauna, 1 minute water bath, and 5 minutes outside air bath)
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1] Healthy Japanese females aged 20-59 years. [2] Individuals who are healthy and have no chronic physical disease including skin disease. [3] Individuals whose written informed consent has been obtained after explanation of this study. [4] Individuals who can have an examination on a designated check day [5]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Individuals using medical products. [2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3] Individuals who have had a bad physical condition in the sauna bath in the past. [4] Individuals with strange skin conditions at measurement points. [5] Individuals with strange skin conditions at measurement points. [6] Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [7] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [8] Individuals who contract or have a history of serious gastrointestinal disease. [9] Individuals with serious anemia. [10] Individuals whose BMI is over 30 kg/m2. [11] Individuals who are a smoker. [12] Individuals who have a habit of using sauna now or within the past 3 months. [13] Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [14] Individuals who have a habit to ingest 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. [15] Individuals who have a habit to use Foods with Function Claims, functional foods and/or supplements claiming to improve cold sensitivity, blood flow, blood pressure, and thermal comfort effect in the past 3 months and/or are planning to use those foods during test periods. [16] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30mg/day). [17] Individuals whose observation date is menstrual [18] Individuals who had been conducted an operation or beauty treatment on the test spot. [19] Individuals who are or are possibly pregnant, or are lactating. [20] Individuals who participated in other clinical studies in the past 3 months. [21] Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indexes for effectiveness(Weight/body fat percentage/BMI(1), Salivary amylase(1), Sublingual thermometry(2), Blood flow measurement with TOKU Capillaro(3), Skin surface temperature measurement with thermography(4), Autonomic nerve function(1), Image analysis by VISIA(1), Skin moisture content(1), Japanese version of the UWIST Mood Checklist(5), St. Mary's Hospital Sleep Questionnaire(6) and Visual Analogue Scale(6).) (1) Before sauna bath and after 30 minutes of 2 sets of sauna bath. (2) Before sauna bath, during outside air bath (2 times), immediately after 2 sets of sauna baths, after 30 minutes of 2 sets of sauna bath. (3) Before sauna bath, immediately after 2 sets of sauna baths, after 30 minutes of 2 sets of sauna bath. (4) Before sauna bath and immediately after 2 sets of sauna baths. (5) Before sauna bath, after 30 minutes of 2 sets of sauna bath and when waking up the next day. (6) Before sauna bath and when waking up the next day. | — |
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. (1)Before sauna bath and after 30 minutes of 2 sets of sauna bath. (2) After 30 minutes of 2 sets of sauna bath. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed