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Completed

NCT Number: NCT01932086

Effects of White Rice, Brown Rice, and Black Rice on Postprandial Glucose and Lipid Profiles in Healthy Korean Adults

This study was an open, 5-treatment, 5-sequence, 5-day cross-over randomized design clinical trial. The present study was carried out to compare the effects of white rice, brown rice, and black rice on postprandial glucose and lipid profiles in healthy human subjects, using a white bread as a positive control.

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Key information

Conditions

Healthy

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 and meal tolerance was measured with blood samples drawn at times 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes and TG was at time 0, 1, 2, 3, 4, 5 and 6 hours.

  • Serum levels of glucose, insulin, and TG were analyzed by biochemical autoanalyzer. The area under the curve (AUC) changes in blood glucose, TG 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%
  • triglyceride (TG) levels less than 200 mg/dL
  • Fasting blood glucose levels less than 100 mg/dL and an oral glucose tolerance test (OGTT) less than 140 mg/dL
  • 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

White rice diet

Dietary Supplement

All test foods contained 50 g available carbohydrate from the test food products. A glass of 250 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min

Brown rice diet

Dietary Supplement

All test foods contained 50 g available carbohydrate from the test food products. A glass of 250 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min

Black rice diet

Dietary Supplement

All test foods contained 50 g available carbohydrate from the test food products. A glass of 250 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min

Bread

Dietary Supplement

All test foods contained 50 g available carbohydrate from the test food products. A glass of 250 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.and the participants were instructed to ingest the breakfast with 10 min.

Other names: Reference diet

Primary outcomes

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

    Time frame: 2 hour postprandial blood glucose, insulin

    • 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.
    • 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

Secondary outcomes

  1. Triglyceride iAUC(incremental area under the curve)

    Time frame: 6 hour postprandial blood triglyceride(TG)

    Triglyceride will be measured at baseline, 0, 1, 2, 3, 4, 5 and 6 hours post ingestion of each test solution, and area under the curve will be calculated.

Other 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 30, 2013
Registry last updated
Sep 2, 2013

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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