Effects of continuous consumption of the test food on postprandial blood glucose level in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study

UMIN ID: UMIN000054038

Registered date:02/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/04/02
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: 12 weeks Test food: Active food 1
Duration: 12 weeks Test food: Active food 2
Duration: 12 weeks Test food: Active food 3
Duration: 12 weeks Test food: Placebo food

Outcome(s)

• Primary Outcome: 1. The measured value of the incremental area under the curve (IAUC) of the blood glucose level at 12 weeks after consumption (12w) [Active food 2 vs. Placebo food]
• Secondary Outcome: 1. The measured values of the IAUC of blood glucose level at 12w [Active food 1 vs. Placebo food, Active food 3 vs. Placebo food] 2. The changes from screening (before consumption; Scr) of the IAUC of blood glucose level at 12w [Active food 2 vs. Placebo food, Active food 1 vs. Placebo food, Active food 3 vs. Placebo food] 3. The measured values and changes from Scr of the maximum blood concentration (Cmax) of blood glucose level at 12w [Active food 2 vs. Placebo food, Active food 1 vs. Placebo food, Active food 3 vs. Placebo food] 4. The measured values and changes from Scr of the fasting blood glucose level (before consumption of the carbohydrate load) and blood glucose level 30, 60, 90, and 120 minutes after consumption of the carbohydrate load at 12w [Active food 2 vs. Placebo food, Active food 1 vs. Placebo food, Active food 3 vs. Placebo food] 5. The measured values and changes from Scr of insulin, body fat percentage, fat mass, and muscle mass at 12w [Active food 2 vs. Placebo food, Active food 1 vs. Placebo food, Active food 3 vs. Placebo food]

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• 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 cannot regularly take three meals (breakfast, lunch, and dinner) a day 5. Individuals who take dairy products such as milk and cheese at least four times a week 6. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 7. Individuals who are taking or using medications (including herbal medicines) and supplements 8. Individuals who are allergic to medications and/or the test food related products (particularly gelatin) 9. Individuals who are pregnant, lactating, or planning to become pregnant during this study 10. 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 11. 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 Chiba University
• Source(s) of Monetary Support: J-OIL MILLS, Inc.,Raffinee International Inc.