A study of the suppressive effects of the test food on the elevation of postprandial blood glucose levels: a randomized, placebo-controlled, double-blind, crossover comparison study

UMIN ID: UMIN000055544

Registered date:19/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/09/19
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: Single ingestion Test food: <Test 1> Active food <Test 2> Placebo food *The intervention sequence is Test 1 to Test 2. *Washout period is for one week or more.
Duration: Single ingestion Test food: <Test 1> Placebo food <Test 2> Active food *The intervention sequence is Test 1 to Test 2. *Washout period is for one week or more.

Outcome(s)

• Primary Outcome: 1. Postprandial blood glucose levels
• Secondary Outcome: 1. Postprandial blood insulin levels

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, or 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 foods related to the test product 7. Individuals who donated blood within the last two months before the agreement to participate in this study 8. Individuals who are pregnant, lactating, or planning to become pregnant during this study 9. Individuals who have been enrolled in other clinical studies within the last three months before the agreement to participate in this study or plan to participate in another study during this study 10. 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: Ezaki Glico Co., Ltd