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

JRCT ID: jRCT1030240440

Registered date:29/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy individuals (Intended indications and effects: Suppression of blood glucose elevation)
• Date of first enrollment: 29/10/2024
• Target sample size: 68
• Study type: Interventional

Intervention(s)

< Intervention 1>
Test food: Ginger extract powder
Duration: Eight weeks
Administration: Take one capsule per day in the morning.

< Intervention 2>
Test food: Dextrin
Duration: Eight weeks
Administration: Take one capsule per day in the morning.

Outcome(s)

• Primary Outcome: 1. The measured values of the IAUC of blood glucose level at eight weeks after consumption (8w)

Secondary Outcome

1. The measured values of the maximum blood concentration (Cmax) of blood glucose level at 8w
2. The measured values of blood glucose level at each measurement point (before and 30, 60, 90, and 120 minutes after consumption of the carbohydrate load) at 8w
3. The measured values of insulin and C-peptide at 8w
4. Blood test (triglyceride, cholesterol, alanine transaminase (ALT), aspartate aminotransferase (AST), and gamma-glutamyltransferase (gamma-GT)), blood pressure, body fat percentage, body weight, body mass index (BMI), and waist circumference at 8w

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

1. Japanese
2. Men or women
3. Healthy individuals
4. Individuals aged >= 20 and <= 64
5. Individuals whose fasting blood glucose level is <= 125 mg/dL and whose blood glucose level after consumption of a carbohydrate load (Trelan-G 75 g) is <= 199 mg/dL at screening (before consumption; Scr)
6. Individuals whose incremental area under the curve (IAUC) of postprandial blood glucose level is relatively large at Scr

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 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 in another study during this study
9. Individuals who are judged as ineligible to participate in this study by the physician

Related Information

• Primary Sponsor: Takara Tsuyoshi