The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Crossover Clinical Trial, The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male

Conditions
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Healthy People, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Mixed grain 1
* Dietary Supplement: Mixed grain 2
* Dietary Supplement: White rice
* Other: Glucose solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Giant embryonic brown rice<br> | Dietary Supplement: Mixed grain 1<br>* All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.<br>* Other names: Mixed grain 1 (Giant embryonic brown rice) diet;|
| Experimental: Giant embryonic rice<br> | Dietary Supplement: Mixed grain 2<br>* All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.<br>* Other names: Mixed grain 2 (Giant embryonic rice) diet;|
| Active Comparator: White rice<br> | Dietary Supplement: White rice<br>* All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.<br>* Other names: control diet;|
| Active Comparator: Glucose solution<br> | Other: Glucose solution<br>* All test foods contained 50 g available carbohydrate from the test food products.<br>* Other names: Reference diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Glycemic index(GI) 2. Glucose, insulin AUC(incremental area under the curve) 3. C-peptide | 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 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. Plasma c-peptide will be measured at baseline, 120 minutes post ingestion of each test solution. | 2 hour postprandial blood glucose, insulin, c-peptide | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homeostatic model assessment-insulin resistance(HOMA-IR), quantitative insulin sensitivity check index(QUICKI), Insulinogenic index(IGI) | HOMA-IR={fasting insulin(µU/㎖) x fasting glucose(m㏖/L)}/22.5 QUICKI=1/log(insulin 0min)-log(glucose 0min) IGI=(insulin 30min-fasting insulin)/(glucose 30min-fasting glucose) | fasting and postprandial (different times for 30min) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mixed grains, Glycemic index, Giant embryonic brown rice, Giant embryonic rice, diabetes