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Completed

NCT Number: NCT01840982

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.

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Key information

Conditions

Healthy People Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

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

About this study

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.

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Mixed grain 1 (Giant embryonic brown rice) diet

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.

Other names: Mixed grain 2 (Giant embryonic rice) diet

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.

Other names: control diet

glucose solution

Other

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

Other names: Reference diet

Primary outcomes

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

    Time frame: 2 hour postprandial blood glucose, insulin, 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.

Secondary outcomes

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

    Time frame: fasting and postprandial (different times for 30min)

    • 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)

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2015
First posted
Apr 26, 2013
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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