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A verification study for the suppressive effect of the test drink on the elevation of postprandial blood glucose

Not Applicable
Conditions
Healthy Japanese subjects
Registration Number
JPRN-UMIN000039556
Lead Sponsor
ORTHOMEDICO Inc.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
36
Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, abnormal glucose tolerance, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period 9. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. The incremental area under the curve (IAUC) of the blood glucose levels
Secondary Outcome Measures
NameTimeMethod
1. The levels of maximum (Cmax) blood glucose 2. Blood glucose levels at before taking the test drink, and at 30, 60, 90, 120 minutes after taking the test drink 3. IAUC of the blood insulin levels 4. The levels of maximum (Cmax) blood insulin 5. Blood insulin levels at before taking the test drink, and at 30, 60, 90, 120 minutes after taking the test drink
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