None listed
Conditions
Interventions
Wearing the product under test (During the day, at bedtime, for 8 weeks).
Wearing a control product (During the day, at bedtime, for 8 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women between 40 and 59 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 their cold nature compared to many others. 4) Individuals who are aware of coldness in the waist, limbs, or other parts of the body, and have daily problems such as swelling, tiredness, etc. 5) Individuals who have the habit of using body warmers or other measures to protect themselves from cold during the winter season. 6) Individuals who can consent to the use of the results of this study in a form that does not personally identify them for use in academic conferences, corporate advertisements, etc. 7) 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. 8) Individuals who can come to the designated venue for this study and be inspected. 9) 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) with metal allergies 5) with scars or inflammation in the evaluation area, as well as a history of cosmetic procedures or treatments in the evaluation area. 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 depression, schizophrenia, or other mental disorders. 10) with severe anemia, sleep disorders requiring treatment. 11) whose BMI is over 25 kg/m2. 12) who are currently, or have been within the past month, habitual consumers of specified health foods, functional foods, or health foods, and individuals who plan to consume such foods during the study period. 13) who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). 14) who are a smoker. 15) with high-intensity exercise habits and individuals on a diet. 16) who engage in a night work. 17) with irregular lifestyle or eating habits, and individuals who may change their lifestyle during the examination period. 18) who may develop skin irritation due to hay fever or seasonal allergic symptoms during the study period. Also, individuals who may use antiallergic drugs (eye drops are acceptable). 19) who cannot intentionally refrain from being exposed to direct sunlight during the examination period, such as sunburns. 20) who are pregnant, lactating or may become pregnant during the study period 21) Individuals who participated in other clinical studies in the past 1 month. 22) who are or whose family is engaged in healthy or functional foods. 23) judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Capillary Assessment (Week 0, Week 4, Week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Indexes for skin function(1) *Sleep Assessment(1) *Experience evaluation(1) *Safety 1) Blood pressure, pulsation (1) 2) Weight, body fat percentage, BMI (1) 3) Doctor's questions (1) 4) Side effects/ Adverse events (2) 5) Subject's diary (3) (1): Week 0, Week 4, Week 8 (2): Week 4, Week 8 (3): Every day from the start date of test product use to the end of the test | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed