Investigation of the effects of using far-infrared blood circulation-promoting garments on capillaries, skin function, sleep, and body sensation

UMIN ID: UMIN000056875

Registered date:30/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: No
• Date of first enrollment: 2025/02/15
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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).

Outcome(s)

• Primary Outcome: * Capillary Assessment (Week 0, Week 4, Week 8)
• Secondary Outcome: *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

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 60years-old
• Gender: Female
• Exclude 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.

Related Information

• Primary Sponsor: TES Holdings Co., Ltd.
• Source(s) of Monetary Support: MTG Co.,Ltd.