Healthy subjects
Conditions
Interventions
Period I: Salt-loading beverage + placebo Period II: Salt-loading beverage + Test Substance A Period III: Salt-loading beverage + Test Substance B Period IV: Salt-loading beverage only The inter
Sponsors
General Incorporated Association, Kendai Translational Research Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male participants who are 18 years of age or older at the time of consent. - Those who have fully understood the purpose and safety of this study as stated in the "Research Cooperation Consent Explanation Form" and have given their consent.
Exclusion criteria
Exclusion criteria: - Subjects with suspected glucose metabolism disorders or diabetes (including those currently undergoing diabetes treatment, those with fasting blood glucose levels above 125 mg/dL or below 60 mg/dL, those with an HbA1c level of 6.5% or higher, and those taking medications or supplements that affect glucose metabolism) - Subjects with or a history of serious illnesses such as high blood pressure, kidney disease, diabetes, liver disease, ischemic heart disease, or digestive system disorders - Subjects whose BMI at the time of provisional registration falls outside the 95% confidence interval (upper or lower limit) of the BMI distribution for all applicants - Subjects whose HIV antigen/antibody, HBV, HCV, or syphilis tests at the screening test are positive - Subjects with obvious abnormalities in hematology or biochemistry tests at the screening test - Subjects who may develop allergic reactions to study-related foods - Subjects with excessive alcohol or smoking habits (drinking more than 1 go of sake per day, equivalent to 3 or more times per week, or smoking more than 20 cigarettes per day) - Subjects deemed unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve of postprandial blood sodium levels over time (AUC). Maximum postprandial blood sodium levels (Cmax). Blood sodium levels (C) at each measurement point. | — |
Countries
Japan
Contacts
Public ContactSatsuki Kimura
General Incorporated Association, Kendai Translational Research Center Clinical Research Department
Outcome results
None listed