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

Chonbuk National University

Status: Completed

Conditions: Healthy People; Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Mixed grain 2; Dietary Supplement: Mixed grain 1; Other: Glucose solution; Dietary Supplement: White rice

Study type: Interventional

Funder types: Other

Identifiers

NCT01840982

CTCF2_2010_MC_2

Details and patient eligibility

About

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.

Full 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.

1. 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.
2. 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.

Enrollment: 20 patients

Sex: Male

Ages: 19 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Giant embryonic brown rice

Experimental group

Treatment:

Dietary Supplement: Mixed grain 1

Giant embryonic rice

Experimental group

Treatment:

Dietary Supplement: Mixed grain 2

White rice

Active Comparator group

Treatment:

Dietary Supplement: White rice

Glucose solution

Active Comparator group

Treatment:

Other: Glucose solution