N/A (healthy adults)
Conditions
Interventions
1 capsule / 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 capsule / day, 1 time) [6]The exposure to cold water stress [7]Observation
[1]Oral intake of the placebo product (not containing long pepper extract
1 capsule / day, 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 capsule / day, 1 time) [6]The exposure to cold water stress [7]Observation
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 20-59 years [2]Individuals who are healthy [3]Individuals whose written informed consent has been obtained [4]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 supplyments 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 is 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 is a smoker [15]Individuals who participated in other clinical studies in the past 3 months [16]Individuals whose AMS scale is over 37 (male) [17]Individuals whose SMI score is over 51 (female) [18]Individuals who have a history of ovarian resection or hysterectomy (female) [19]Individuals whose prospected date of the ovulation is 2 days before or after the observation day (female) [20]Individuals who are or are posslibly, or are lactating (female) [21]Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Blood flow (Preliminary observation, First bbservation, Second observation) [2]Skin surface temperature (Preliminary observation, First bbservation, Second observation) | — |
Secondary
| Measure | Time frame |
|---|---|
| [1]Subjective questionnaire (Preliminary observation, First bbservation, Second observation) [2]Physician's interview (Preliminary observation, First bbservation, Second observation) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd Department of Clinical Trial
Outcome results
None listed