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

UMIN ID: UMIN000047768

Registered date:16/05/2022

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy Japanese subjects
• Date of first enrollment: 2022/04/28
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Period I: Sennen no aojiru Period II: Placebo Carbohydrate load: Trelan-G 50 g After taking blood samples prior to the ingestion of test foods, take one pack of the test food or placebo with approximately 200 mL of water. After 10 minutes, take the carbohydrate load within 5~10 minutes. *The intervention sequence is Period I to Period II, and each food is single ingestion. *Washout period is for one week and more
Period I: Placebo Period II: Sennen no aojiru Carbohydrate load: Trelan-G 50 g After taking blood samples prior to the ingestion of test foods, take one pack of the test food or placebo with approximately 200 mL of water. After 10 minutes, take the carbohydrate load within 5~10 minutes. *The intervention sequence is Period I to Period II, and each food is single ingestion. *Washout period is for one week and more

Outcome(s)

• Primary Outcome: 1. The incremental area under the curve (IAUC) of the postprandial blood glucose
• Secondary Outcome: 1. The maximum blood concentration (Cmax) of the postprandial blood glucose 2. The blood glucose level before consumption of the test food, at 30, 60, 90, and 120 minutes after consumption of the test food

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. Subjects who 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 suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in the 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: ENICIA Inc.