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

NCT01840982 | Completed DMC

• 1 other identifier: CTCF2_2010_MC_2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy People; Diabetes Mellitus, Type 2

Keywords

Mixed grains; Glycemic index; Giant embryonic brown rice; Giant embryonic rice; diabetes

Outcome Measures

Primary Outcomes (1)

• 1. Glycemic index(GI) 2. Glucose, insulin AUC(incremental area under the curve) 3. C-peptide

  1. 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 2. 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. 3. 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 Outcomes (1)

• Homeostatic model assessment-insulin resistance(HOMA-IR), quantitative insulin sensitivity check index(QUICKI), Insulinogenic index(IGI)

  fasting and postprandial (different times for 30min)

Study Arms (4)

Giant embryonic brown rice

EXPERIMENTAL

Dietary Supplement: Mixed grain 1

Giant embryonic rice

EXPERIMENTAL

Dietary Supplement: Mixed grain 2

White rice

ACTIVE COMPARATOR

Dietary Supplement: White rice

Glucose solution

ACTIVE COMPARATOR

Other: Glucose solution

Interventions

Mixed grain 1 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.

Also known as: Mixed grain 1 (Giant embryonic brown rice) diet

Giant embryonic brown rice

Mixed grain 2 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.

Also known as: Mixed grain 2 (Giant embryonic rice) diet

Giant embryonic rice

White rice 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.

Also known as: control diet

White rice

Glucose solution OTHER

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

Also known as: Reference diet

Glucose solution

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Diet

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Soo-Wan Chae, MD., PhD

  Chonbuk National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 26, 2013
• Study Start: October 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: March 25, 2015
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

KR (1)