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

NCT ID: NCT01840982

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-03-25

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.

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.

Conditions

Healthy People; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Giant embryonic brown rice

Group Type: EXPERIMENTAL

Mixed grain 1

Intervention Type: DIETARY_SUPPLEMENT

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.

Giant embryonic rice

Group Type: EXPERIMENTAL

Mixed grain 2

Intervention Type: DIETARY_SUPPLEMENT

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.

White rice

Group Type: ACTIVE_COMPARATOR

White rice

Intervention Type: DIETARY_SUPPLEMENT

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.

Glucose solution

Group Type: ACTIVE_COMPARATOR

Glucose solution

Intervention Type: OTHER

All test foods contained 50 g available carbohydrate from the test food products.

Interventions

Mixed grain 1

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.

Intervention Type: DIETARY_SUPPLEMENT

Mixed grain 2

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.

Intervention Type: DIETARY_SUPPLEMENT

White rice

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.

Intervention Type: DIETARY_SUPPLEMENT

Glucose solution

All test foods contained 50 g available carbohydrate from the test food products.

Intervention Type: OTHER

Other Intervention Names

Mixed grain 1 (Giant embryonic brown rice) diet; Mixed grain 2 (Giant embryonic rice) diet; control diet; Reference diet

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo-Wan Chae

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soo-Wan Chae, MD., PhD

Role: STUDY_DIRECTOR

Chonbuk National University Hospital

Locations

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Countries

South Korea

Other Identifiers

CTCF2_2010_MC_2

Identifier Type: -

Identifier Source: org_study_id