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

Sponsor

Chonbuk National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01932086

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

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.

Study Design

Study Type:

Interventional

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 :

Mar 1, 2011

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: control diet

Outcome Measures

Primary Outcome Measures

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

Triglyceride iAUC(incremental area under the curve) [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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