HealthyNCT01932086
Effects of White Rice, Brown Rice, and Black Rice on Postprandial Glucose and Lipid Profiles in Healthy Korean Adults
A study testing White rice diet, Brown rice diet and Black rice diet in people with Healthy, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- White rice diet, Brown rice diet and Black rice diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822
About this study
Official title: A Randomized, Crossover Clinical Trial
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- White rice diet, Brown rice diet, Black rice diet, Bread, Glucose solution
- Keywords
- male, Glucose, Triglyceride, Glycemic index, White rice, Brown rice, Black rice, Bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White rice dietDietary 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 dietDietary 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 dietDietary 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
BreadDietary supplement
Also called control 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
Glucose solutionOther
Also called Reference diet
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.
| Study group | Role | What they receive |
|---|---|---|
| White rice | Experimental | Not described Receives: Dietary Supplement: White rice diet; Dietary Supplement: Brown rice diet; Dietary Supplement: Black rice diet; Dietary Supplement: Bread; Other: Glucose solution |
| Brown rice | Experimental | Not described Receives: Dietary Supplement: White rice diet; Dietary Supplement: Brown rice diet; Dietary Supplement: Black rice diet; Dietary Supplement: Bread; Other: Glucose solution |
| Black rice | Experimental | Not described Receives: Dietary Supplement: White rice diet; Dietary Supplement: Brown rice diet; Dietary Supplement: Black rice diet; Dietary Supplement: Bread; Other: Glucose solution |
| Bread | Active comparator | Not described Receives: 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 | Not described Receives: Dietary Supplement: White rice diet; Dietary Supplement: Brown rice diet; Dietary Supplement: Black rice diet; Dietary Supplement: Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Glucose, insulin AUC(incremental area under the curve) 2. Glycemic index(GI)
- 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
Measured: 2 hour postprandial blood glucose, insulin
Secondary outcomes (1)
Triglyceride iAUC(incremental area under the curve)
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.
Measured: 6 hour postprandial blood triglyceride(TG)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startMar 2011
- Primary completionApr 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
- Investigators
- Soo-Wan Chae, MD., PhD, Study director, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932086
- Sponsor's protocol ID
- CTCF2_2011_RP_1
- Status last verified
- Aug 2013
- First submitted
- 21 Aug 2013
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT01932086
- Acronym / sponsor ID
- CTCF2_2011_RP_1
- Conditions
- Healthy
- Keywords
- male, Glucose, Triglyceride, Glycemic index, White rice, Brown rice, Black rice, Bread
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White rice dietAll 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, Bread, Brown rice, Glucose solution, White rice |
| Brown rice dietAll 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, Bread, Brown rice, Glucose solution, White rice |
| Black rice dietAll 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, Bread, Brown rice, Glucose solution, White rice |
| BreadAlso: control dietAll 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, Bread, Brown rice, Glucose solution, White rice |
| Glucose solutionAlso: Reference dietAll 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 | Black rice, Bread, Brown rice, White rice |
Primary outcome
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
1 secondary outcome
Triglyceride iAUC(incremental area under the curve)
Time frame: 6 hour postprandial blood triglyceride(TG)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soo-Wan Chae, MD., PhD study director
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White rice diet, Brown rice diet and Black rice diet in people with Healthy, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Glucose, insulin AUC(incremental area under the curve) 2. Glycemic index(GI) (time frame: 2 hour postprandial blood glucose, insulin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2013.