A verification study of elevation of postprandial blood glucose level

UMIN ID: UMIN000053958

Registered date:25/03/2024

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/03/25
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: Single ingestion (21 types of test foods) Consumption of the test foods (order 1)
Duration: Single ingestion (21 types of test foods) Consumption of the test foods (order 2)
Duration: Single ingestion (21 types of test foods) Consumption of the test foods (order 3)
Duration: Single ingestion (21 types of test foods) Consumption of the test foods (order 4)
Duration: Single ingestion (21 types of test foods) Consumption of the test foods (order 5)
Duration: Single ingestion (21 types of test foods) Consumption of the test foods (order 6)

Outcome(s)

• Primary Outcome: 1. The incremental area under the curve (IAUC) of the blood glucose level
• Secondary Outcome: 1. The maximum blood concentration (Cmax) of glucose, the measured values of the blood glucose level at each assessment point 2. The IAUC of visual analog scale (VAS), the measured values of VAS at each assessment point

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude 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 who are 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, gastrointestinal disorder, or any other chronic diseases 4. Individuals who usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 5. Individuals who are a smoker 6. Individuals who have irregular sleeping time or habit due to work such as a late-night shift 7. Individuals who have irregular lifestyles 8. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 9. Individuals who are taking or using medications (including herbal medicines) and supplements 10. Individuals who are allergic to medicines and/or the test product related products (particularly, eggs, wheat, buckwheat, milk ingredients, pork, chicken, beef, peanuts, soybeans, squid, shrimp, mackerel, salmon, sesame, apple, peach, and gelatin) 11. Individuals who are pregnant, lactating, or planning to become pregnant during this study 12. 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 13. Individuals who are judged as ineligible to participate in this study by the physician

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: NISSIN FOODS HOLDINGS CO., LTD.