N/A (healthy adults)
Conditions
Interventions
1 package in a day
1 time) [2]The exposure to cold water stress [3]Observation [4]Washout (1 week) [5]Oral intake of the placebo product (not containing long pepper extract
1 time) [6]The exposure to cold water stress [7]Observation
[1]Oral intake of the placebo product (not containing long pepper extract
1 time) [2]The exposure to cold water stress [3]Observation [4]Washout (1 week) [5]Oral intake of the test product (containing long pepper extract
1 time) [6]The exposure to cold water stress [7]Observation
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1]Japanese females aged 20-64 years. [2]Individuals who are healthy. [3]Individuals who are sensitive to cold. [4]Individuals whose written informed consent has been obtained. [5]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products. [2]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [3]Individuals who use a drug to treat a disease. [4]Individuals who were an asthmatic patient in the past 3 months or is an asthmatic patient. [5]Individuals with serious anemia. [6]Individuals who are sensitive to a test product or other foods, and medical products. [7]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [8]Individuals with serious diseases (ex. diabetes, hepatopathy disease, kidney damage, heat failure, endocrine disease), or who are a patient of or have a history of thyroid disease, adrenal disease, metabolic disease). [9]Individuals who conducted hormone replacement therapy in the past 3 months or have a history of conducting hormone replacement therapy. [10]Individuals who have an inflammation or a scar on a measuring area. [11]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg. [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [13]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [14]Individuals who are a smoker. [15]Individuals who participated in other clinical studies in the past 3 months. [16]Individuals whose Simplified Menopausal Index score is over 51. [17]Individuals who have a history of ovarian resection or hysterectomy. [18]Individuals who are or are possibly, or are lactating. [19]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Blood flow measurement with laser doppler (First observation, Second observation) [2]Skin surface temperature measurement with thermography (Screening, First observation, Second observation) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Axillary temperature (Screening, First observation, Second observation) [2]Doctor's questions (Screening, First observation, Second observation) [3]Subject's diary(From the first day of ingestion of a test material to the last day of the test) *Other indexes [1]Height, weight, body fat percentage, BMI (Screening) [2]Blood pressure (Screening) [3]Subjective questionnaire on cold (Screening) [4]Simplified Menopausal Index (Screening) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd Administrative Department of Clinical Trials
Outcome results
None listed