A verification study of the suppressive effect on the elevation of blood glucose level: a randomized, placebo-controlled, open-label, crossover comparison study

UMIN ID: UMIN000053899

Registered date:19/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/03/19
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: Once Test food: < Test 1> Tea beverage < Test 2> Placebo beverage *The intervention sequence is Test 1 to Test 2. *Washout period is for one week and more.
Duration: Once Test food: <Test 1> Placebo beverage < Test 2> Tea beverage *The intervention sequence is Test 1 to Test 2. *Washout period is for one week and more.

Outcome(s)

• Primary Outcome: 1. The maximum blood concentration (Cmax) of the glucose 2. The incremental area under the curve (IAUC) of the blood glucose
• Secondary Outcome: 1. The total AUC (TAUC), delta Cmax (difference from before carbohydrate load to Cmax), and the time to maximum blood concentration (Tmax) of the blood glucose 2. IAUC and Cmax of the blood insulin levels 3. The measured values of the blood glucose and insulin levels at 0, 30, 60, 90, and 120 minutes after consumption of the carbohydrate load, and the amount of changes of each item from 0 minutes after consumption of the carbohydrate load

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 64years-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, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and/or foods related to the test product, particularly who show allergic reactions to green tea, rice, and/or agar 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

Related Information

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