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A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose

Not Applicable
Conditions
Healthy Japanese
Registration Number
JPRN-UMIN000052746
Lead Sponsor
ORTHOMEDICO Inc.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
48
Inclusion Criteria

Not provided

Exclusion Criteria

1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who use or take "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who take medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines, the test food related products, tea, wheat, milk ingredients, eggs, and/or soybeans 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 9. Individuals who are judged as ineligible to participate in this study by the physician 10. Individuals whose physical condition is impaired easily by caffeine

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. The maximum blood concentration (Cmax) of the glucose
Secondary Outcome Measures
NameTimeMethod
1. The incremental area under the curve (IAUC) of the blood glucose levels from before to 30, 60, 90, and 120 minutes after consumption of test food 2. The total AUC (TAUC) of the blood glucose levels from before to 30, 60, 90, and 120 minutes after consumption of test food 3. The measured value of blood glucose level at 30, 60, 90, and 120 minutes after consumption of the test food 4. The amount of change of blood glucose level from before to 30, 60, 90, and 120 minutes after consumption of the test food 5. The feeling of satiety measured by visual analog scale (VAS) before and immediately, 30, 60, 90, and 120 minutes after consumption of the test food 6. The IAUC of the feeling of satiety measured by VAS from before to 120 minutes after consumption of test food
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