A Randomized, Crossover Clinical Trial, The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 1. Glycemic index(GI) 2. Glucose, insulin AUC(incremental area under the curve) 3. C-peptide
Study Overview
Brief Summary
This study was an open, 4-treatment, 5-sequence, 5-day cross-over randomized design clinical trial to evaluate the efficacy of mixed grain on blood glucose, insulin and Glycemic index(GI) in healthy males.
Detailed Description
After a 12-hour fast, oral glucose or meal tolerance test was performed with blood samples drawn at time 0, 15, 30, 45, 90, 120, 150, and 180 min.
- Serum levels of glucose, insulin, and C-peptide were analyzed by biochemical autoanalyzer. The area under the curve (AUC) changes in blood glucose were computed by the trapezoidal method.
- Glycemic index(GI): the area under the glucose response curve after consumption of a test food divided by the area under the curve after consumption of a control food containing the same amount of carbohydrate and calculated using 50 g glucose as the reference.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Males, 19~60years old
- •Bodyweight was more than 50 kg with ideal body weight within ±30%
- •Less than 100 mg/dl in fasting blood glucose and less than 140 mg/dl in an oral glucose tolerance test (OGTT)
- •Able to give informed consent
Exclusion Criteria
- •Major medical illness such as cardiovascular, neurologic, psychiatric, renal, pulmonary and hepatic diseases
- •History of disease that could interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery
- •Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- •Poor vital sign (systolic blood pressure: below 100 mmHg or above 150 mmHg, diastolic blood pressure: below 65 mmHg or above95 mmHg)
- •Allergic or hypersensitive to any of the ingredients in the test products; treated with any drug within past 2 weeks
- •Participation in any other clinical trials within past 2 months
- •Alcohol consumption above 21 units per week or abnormal screening laboratory test
- •Being judged by the responsible physician of the local study center as unfit to participate in the study
Arms & Interventions
Giant embryonic rice
Intervention: Mixed grain 2 (Dietary Supplement)
White rice
Intervention: White rice (Dietary Supplement)
Glucose solution
Intervention: Glucose solution (Other)
Giant embryonic brown rice
Intervention: Mixed grain 1 (Dietary Supplement)
Outcomes
Primary Outcomes
1. Glycemic index(GI) 2. Glucose, insulin AUC(incremental area under the curve) 3. C-peptide
Time Frame: 2 hour postprandial blood glucose, insulin, c-peptide
1. Glycemic index (GI) was defined as the area under the glucose response curve after consumption of a test food divided by the area under the curve after consumption of a control food containing the same amount of carbohydrate and calculated using 50 g glucose as the reference. Plasma glucose will be measured at baseline, 15, 30, 45, 60, 90, and 120 minutes post ingestion of each test solution. GI= (incremental blood glucose area of test meal/incremental area of glucose) × 100 2. Plasma glucose and insulin will be measured at baseline, 15, 30, 45, 60, 90, 120, 180 and 240 minutes post ingestion of each test solution, and area under the curve will be calculated. 3. Plasma c-peptide will be measured at baseline, 120 minutes post ingestion of each test solution.
Secondary Outcomes
- Homeostatic model assessment-insulin resistance(HOMA-IR), quantitative insulin sensitivity check index(QUICKI), Insulinogenic index(IGI)(fasting and postprandial (different times for 30min))
Investigators
Soo-Wan Chae
Director
Chonbuk National University Hospital