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

NCT01932086 | Completed DMC

• 1 other identifier: CTCF2_2011_RP_1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

male; Glucose; Triglyceride; Glycemic index; White rice; Brown rice; Black rice; Bread

Outcome Measures

Primary Outcomes (1)

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

  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

  2 hour postprandial blood glucose, insulin

Secondary Outcomes (1)

• Triglyceride iAUC(incremental area under the curve)

  6 hour postprandial blood triglyceride(TG)

Other 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 (5)

White rice

EXPERIMENTAL

Dietary Supplement: White rice diet; Dietary Supplement: Brown rice diet; Dietary Supplement: Black rice diet; Dietary Supplement: Bread; Other: Glucose solution

Brown rice

EXPERIMENTAL

Dietary Supplement: White rice diet; Dietary Supplement: Brown rice diet; Dietary Supplement: Black rice diet; Dietary Supplement: Bread; Other: Glucose solution

Black rice

EXPERIMENTAL

Dietary Supplement: White rice diet; Dietary Supplement: Brown rice diet; Dietary Supplement: Black rice diet; Dietary Supplement: Bread; Other: Glucose solution

Bread

ACTIVE COMPARATOR

Dietary Supplement: White rice diet; Dietary Supplement: Brown rice diet; Dietary Supplement: Black rice diet; Dietary Supplement: Bread; Other: Glucose solution

Glucose solution

ACTIVE COMPARATOR

Dietary Supplement: White rice diet; Dietary Supplement: Brown rice diet; Dietary Supplement: Black rice diet; Dietary Supplement: Bread

Interventions

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

Black rice; Bread; Brown rice; Glucose solution; White rice

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; Bread; Brown rice; Glucose solution; White rice

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

Black rice; Bread; Brown rice; Glucose solution; White rice

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

Also known as: control diet

Black rice; Bread; Brown rice; Glucose solution; White rice

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.

Also known as: Reference diet

Black rice; Bread; Brown rice; White rice

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%
• 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

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

Interventions

Bread

Intervention Hierarchy (Ancestors)

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

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: August 21, 2013
• First Posted: August 30, 2013
• Study Start: March 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 2, 2013

Record last verified: 2013-08

Locations

KR (1)