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Trial record 28 of 1009 for:    Area Under Curve AND insulin

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

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ClinicalTrials.gov Identifier: NCT01932086
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : September 2, 2013
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: White rice diet Dietary Supplement: Brown rice diet Dietary Supplement: Black rice diet Dietary Supplement: Bread Other: Glucose solution Not Applicable

Detailed Description:

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.

  1. 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.
  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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Crossover Clinical Trial
Study Start Date : March 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: White rice Dietary Supplement: White rice diet
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

Dietary Supplement: Brown rice diet
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

Dietary Supplement: Black rice diet
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

Dietary Supplement: Bread
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 Name: control diet

Other: Glucose solution
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 Name: Reference diet

Experimental: Brown rice Dietary Supplement: White rice diet
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

Dietary Supplement: Brown rice diet
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

Dietary Supplement: Black rice diet
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

Dietary Supplement: Bread
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 Name: control diet

Other: Glucose solution
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 Name: Reference diet

Experimental: Black rice Dietary Supplement: White rice diet
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

Dietary Supplement: Brown rice diet
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

Dietary Supplement: Black rice diet
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

Dietary Supplement: Bread
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 Name: control diet

Other: Glucose solution
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 Name: Reference diet

Active Comparator: Bread Dietary Supplement: White rice diet
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

Dietary Supplement: Brown rice diet
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

Dietary Supplement: Black rice diet
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

Dietary Supplement: Bread
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 Name: control diet

Other: Glucose solution
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 Name: Reference diet

Active Comparator: Glucose solution Dietary Supplement: White rice diet
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

Dietary Supplement: Brown rice diet
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

Dietary Supplement: Black rice diet
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

Dietary Supplement: Bread
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 Name: control diet




Primary Outcome Measures :
  1. 1. Glucose, insulin AUC(incremental area under the curve) 2. Glycemic index(GI) [ Time Frame: 2 hour postprandial blood glucose, insulin ]
    1. 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.
    2. 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 Outcome Measures :
  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 Outcome Measures:
  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) ]
    1. HOMA-IR={fasting insulin(µU/㎖) x fasting glucose(m㏖/L)}/22.5
    2. QUICKI=1/log(insulin 0min)-log(glucose 0min)
    3. IGI=(insulin 30min-fasting insulin)/(glucose 30min-fasting glucose)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932086


Locations
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Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
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Study Director: Soo-Wan Chae, MD., PhD Chonbuk National University Hospital

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Responsible Party: Soo-Wan Chae, Director, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01932086     History of Changes
Other Study ID Numbers: CTCF2_2011_RP_1
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013

Keywords provided by Soo-Wan Chae, Chonbuk National University Hospital:
male
Glucose
Triglyceride
Glycemic index
White rice
Brown rice
Black rice
Bread