A verification study for the suppressive effect on the elevation of blood glucose level by continuous consumption of test food: a randomized, placebo-controlled, double-blind, crossover comparison study

UMIN ID: UMIN000054165

Registered date:16/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/04/16
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: Four weeks Test food: < Test 1> Capsule containing plant extract < Test 2> Placebo capsule *The intervention sequence is Test 1 to Test 2. *Washout period is for four weeks and more.
Duration: Four weeks Test food: <Test 1> Placebo capsule < Test 2> Capsule containing plant extract *The intervention sequence is Test 1 to Test 2. *Washout period is for four weeks and more.

Outcome(s)

• Primary Outcome: 1. The maximum blood concentration (Cmax) of the glucose at four weeks after consumption (4w) 2. The incremental area under the curve (IAUC) of the glucose at 4w
• Secondary Outcome: 1. The total AUC (TAUC), delta Cmax, and the time to maximum blood concentration (Tmax) of the glucose at 4w 2. IAUC and Cmax of the insulin levels at 4w 3. The measured values of the glucose and insulin levels at 0, 30, 60, 90, and 120 minutes after consumption of the carbohydrate load, and the amount of changes of glucose from 0 minute 4. Homeostasis model assessment of insulin resistance (HOMA-IR) at 4w

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 gelatin, beef, ragweed, chrysanthemum, marigold and/or daisy 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.