None listed
Conditions
Interventions
[1]Oral ingestion of a test food A (1 time). [2]Observation. [3]Washout (14 days) [4]Oral ingestion of a test food B (1 time). [5]Observation. [6]Washout (14 days) [7]Oral ingestion of a test fo
Sponsors
CXwellness, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1]Males 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 foods. [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. [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 smoke an average of 21 or more cigarettes per day [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(0-360min), iAUC(0-360min), Cmax. (before and 15,30,60,120,360 minutes after ingestion of the test food. [observation period I,II,III and IV]) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes Indexes for biokinetics Tmax, AUC0-inf, T1/2, MRT(Mean Residence Time), Kel(elimination rate constant). (before and 15,30,60,120,360 minutes after ingestion of the test food.[observation period I, II, III and IV]) *Safety [1] measurement of body 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)(3) [8] Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (3) (1):Screening, observation period I, II, III and IV (2):Screening (3):Observation period I, II, III and IV *Other index [1] Baseline characteristics(Screening) [2] Height(Screening) [3] Weight, body fat percentage, BMI(Screening, observation period I, II, III and IV) | — |
Countries
Japan
Contacts
Public ContactTatsuo Uetake
CXwellness, Inc. Representative Director
Outcome results
None listed