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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Healthy People
• Intervention / Treatment: Dietary supplement: Mixed grain 1; Dietary supplement: Mixed grain 2; Dietary supplement: White rice; Other: Glucose solution

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Giant embryonic brown rice	Dietary supplement: 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.; Other Names: Mixed grain 1 (Giant embryonic brown rice) diet
Experimental: Giant embryonic rice	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.; Other Names: Mixed grain 2 (Giant embryonic rice) diet
Active Comparator: White rice	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.; Other Names: control diet
Active Comparator: Glucose solution	Other: Glucose solution; All test foods contained 50 g available carbohydrate from the test food products.; Other Names: Reference diet

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): March 25, 2015

Study Registration Dates

• First Submitted: April 5, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (Estimate): April 26, 2013

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: diabetes; Glycemic index; Mixed grains; Giant embryonic brown rice; Giant embryonic rice
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CTCF2_2010_MC_2