Healthy Japanese adult people
Conditions
Interventions
I. Salt excretion supplement II. Placebo supplement * The intervention sequence is I-II, and each food is single ingestion. * Take 3 capsules before eating the prescribed diet (2 rice balls: the in
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult people 2. Subjects who are judged as eligible to participate in the study by the principal investigator 3. Select the participants as equal as possible based on sodium concentration in blood at screening
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are pregnant, breast-feeding, and planning to become pregnant 7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 8. Subjects who are judged as ineligible to participate in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under curve (AUC) of sodium concentration (Na) in blood between before meal and 120 minutes after meal * Take blood samples before eating the prescribed diet and at 30, 60, 90, and 120 minutes after meal (total 5 times). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-1. Sodium (Na) concentration in blood 1-2. Iron (Fe) concentration in blood 1-3. Potassium (K) concentration in blood 1-4. Chloride (Cl) concentration in blood 1-5. Inorganic phosphate (IP) concentration in blood 2. systolic blood pressure, diastolic blood pressure, and pulse rate *1 Take blood samples before eating the prescribed diet and at 30, 60, 90, and 120 minutes after meal (total 5 times). For 1-1, the blood sodium concentration is evaluated before meal and at 30, 60, 90, and 120 minutes after meal. For 1-2 ~ 1-5, the area under curve (AUC) is evaluated between before meal and 120 minutes after meal. *2 Physical examination is conducted before eating the prescribed diet and at 30, 60, 90, and 120 minutes after meal (total 5 times). | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed