N/A (healthy adults or adults being sensitive to the cold)
Conditions
Interventions
[1]Oral intake of the test product (hydrogen water, 1 time) [2]Observation [3]Washout (1 week) [4]Oral intake of the placebo product (not hydrogen water, 1 time) [5]Observation
[1]Oral intake of
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1]Japanese healthy females aged 35-59 years [2]Individuals who are sensitive to the cold [3]Individuals whose written informed consent has been obtained [4]Individuals who can come to the designated venue for this study and be inspected [5]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 [3]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis) [4]Individuals who conducted hormone replacement therapy in the past 3 months or have a history of conducting hormone replacement therapy [5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease [6]Individuals who are a patient or have a history of or endocrine disease [7]Individuals with serious anemia [8]Individuals who are sensitive to a test product or other foods, and medical products [9]Individuals who have a habit to intake hydrogen water [10]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 [11]Individuals who have an inflammation or a scar on a measuring area [12]Individuals whose BMI is over 25 [13]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg [14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [15]Individuals who are a smoker [16]Individuals who participated in other clinical studies in the past 3 months [17]Individuals whose SMI score is over 66 [18]Individuals who have a history of ovarian resection or hysterectomy [19]Individuals who are or are posslibly, or are lactating [20]Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Blood flow speed at the end of fingers (Preliminary observation, First observation, Second observation) [2]Blood flow (First observation, Second observation) | — |
Secondary
| Measure | Time frame |
|---|---|
| [1]Weight, body fat percentage, BMI (Preliminary observation, First observation, Second observation) [2]Blood pressure, pulsation (Preliminary observation, First observation, Second observation) [3]Body temperature (Preliminary observation, First observation, Second observation) [4]Doctor's questions (Preliminary observation, First observation, Second observation) [5]Simplified Menopausal Index (Preliminary observation) [6]Subject's diary (each day during the test period) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Division of Clinical Trial, Department of Development for Clinical Trials
Outcome results
None listed