None listed
Conditions
Interventions
Sponsors
CXwellness, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Males and females aged 20-64 years. [2]Individuals who are healthy and have no chronic physical disease including skin disorder. [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 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 BMI is less than 18.5kg/m2 and over 30kg/m2. [7]Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively. [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [9]Individuals who experienced unpleasant feeling during blood drawing. [10]Individuals who are sensitive to the test food. [11]Individuals who habitually take the foods for specified health uses (FOSHU) or functional food. [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [13]Individuals who are or are possibly, or are lactating. [14]Individuals who participated in other clinical studies in the past one month. [15]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indexes for biokinetics (AUC [0-24h], iAUC [0-24h] and Cmax:before ingestion of the test product, and 30 minutes,1,2,4,6,12, and 24 hours after ingestion of the test product.) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1]Indexes for biokinetics (Tmax, AUC [0-inf], T1/2, MRT, Kel:before ingestion of the test product, and 30 minutes,1,2,4,6,12, and 24 hours after ingestion of the test product.) *Safety [1] Axillary temperature(1) [2] Blood pressure, pulsation(1) [3] Hematologic test(2) [4] Blood biochemical test(2) [5] Urine analysis(2) [6] Doctor's questions(1) [7] Side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed)(1) [8] Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed)(1) *Other index [1] Baseline characteristics(3) [2] Height(3) [3] Weight, body fat percentage, BMI(3) (1): Before ingestion of the test product, and 12 and 24 hours after ingestion of the test product. (2): Before ingestion of the test product, and 24 hours after ingestion of the test product. (3): Before ingestion of the test product. | — |
Countries
Japan
Contacts
Public ContactTatsuo Uetake
CXwellness, Inc. Representative Director
Outcome results
None listed