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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840982
• Other study ID #: CTCF2_2010_MC_2
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: March 25, 2015

Study information

• Verified date: August 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 25, 2015
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy People

Intervention

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.
• 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.
• 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:
• Glucose solution
All test foods contained 50 g available carbohydrate from the test food products.

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)