N/A (healthy adults)
Conditions
Interventions
[1]A cold stress test. [2]Measurement. [3]Oral intake of the test food (3 capsules in a day
4 weeks). [4]A cold stress test. [5]Measurement.
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1]Healthy Japanese females aged 30-49 years. [2]Individuals who are healthy and have no chronic physical disease. [3]Individuals who are aware of being sensitive to cold. [4]Individuals whose written informed consent has been obtained. [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 who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. Individuals who use a drug for treatment of disease. [3]Individuals who use a drug to treat a disease in the past 1 month. [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [5]Individuals who are a patient or have a history of or endocrine disease. [6]Individuals whose menstruation is irregular (individuals whose menstruation cycle must be 28 +- 2 days). [7]Individuals whose BMI is less than 18.5kg/m2 or over 25kg/m2. [8]Individuals with serious anemia. [9]Individuals who are a smoker. [10]Individuals with inflammation and scratch at fingers. [11]Individuals who have excessive alcohol intake more than 60 g in a day of pure alcohol equivalent. [12]Individuals who have allergic reaction to ingredients of test foods and other foods or drugs. [13]Individuals with possible changes of life style during the test period. [14]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. [15]Individuals who are or are possibly, or are lactating. [16]Individuals who participated in other clinical studies in the past 3 months. [17]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company. [18]Individuals judged inappropriate for the trial by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Indexes for effectiveness (blood flow measurement with laser doppler(1), skin surface temperature measurement with thermography(1), image instrumentation of capillary vessel(2), Subjective questionnaire(1). (1)Screening, Week 4: before the cold stress test, just after the cold stress test, 2 min. after the cold stress test, 4 min. after the cold stress test, 6 min. after the cold stress test, 8 min. after the cold stress test, 10 min. after the cold stress test. (2)Screening, Week 4: before the cold stress test. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Safety indexes [1]Blood pressure, pulsation(1) [2]Weight, body fat percentage, BMI(1) [3]Axillary temperature(1) [4]Hematologic test(1) [5]Blood biochemical test(1) [6]Urine analysis(1) [7]Doctor's questions(1) [8]Side effects and adverse events(2) [9]Subject's diary(3) (1)Screening, Week 4: before the cold stress test. (2)Week 4: before the cold stress test. (3)each day from Screening and one day before the Week 4. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed