Healthy PeopleNCT01840982
The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male
A study testing Mixed grain 1, Mixed grain 2 and White rice in people with Healthy People and Diabetes Mellitus, Type 2, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This study was an open, 4-treatment, 5-sequence, 5-day cross-over randomized design clinical trial to evaluate the efficacy of mixed grain on blood glucose, insulin and Glycemic index(GI) in healthy males. 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 People, Diabetes Mellitus, Type 2
- What is being tested?
- Mixed grain 1, Mixed grain 2 and White rice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to 25 Mar 2015
- 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%
- Less than 100 mg/dl in fasting blood glucose and less than 140 mg/dl in an oral glucose tolerance test (OGTT)
- 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, The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male
This study was an open, 4-treatment, 5-sequence, 5-day cross-over randomized design clinical trial to evaluate the efficacy of mixed grain on blood glucose, insulin and Glycemic index(GI) in healthy males.
Read the detailed description
After a 12-hour fast, oral glucose or meal tolerance test was performed with blood samples drawn at time 0, 15, 30, 45, 90, 120, 150, and 180 min.
- Serum levels of glucose, insulin, and C-peptide were analyzed by biochemical autoanalyzer. The area under the curve (AUC) changes in blood glucose 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 People, Diabetes Mellitus, Type 2
- Being tested
- Mixed grain 1, Mixed grain 2, White rice, Glucose solution
- Keywords
- Mixed grains, Glycemic index, Giant embryonic brown rice, Giant embryonic rice, diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed grain 1Dietary supplement
Also called Mixed grain 1 (Giant embryonic brown rice) diet
All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.
Mixed grain 2Dietary supplement
Also called Mixed grain 2 (Giant embryonic rice) diet
All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.
White riceDietary supplement
Also called control diet
All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 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.
| Study group | Role | What they receive |
|---|---|---|
| Giant embryonic brown rice | Experimental | Not described Receives: Dietary Supplement: Mixed grain 1 |
| Giant embryonic rice | Experimental | Not described Receives: Dietary Supplement: Mixed grain 2 |
| White rice | Active comparator | Not described Receives: Dietary Supplement: White rice |
| Glucose solution | Active comparator | Not described Receives: Other: Glucose solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Glycemic index(GI) 2. Glucose, insulin AUC(incremental area under the curve) 3. C-peptide
- 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
- 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.
- Plasma c-peptide will be measured at baseline, 120 minutes post ingestion of each test solution.
Measured: 2 hour postprandial blood glucose, insulin, c-peptide
Secondary outcomes (1)
Homeostatic model assessment-insulin resistance(HOMA-IR), quantitative insulin sensitivity check index(QUICKI), Insulinogenic index(IGI)
- 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)
Measured: fasting and postprandial (different times for 30min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startOct 2010
- Primary completionNov 2010
- Study completion25 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PeopleStudies 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
- 20 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
- NCT01840982
- Sponsor's protocol ID
- CTCF2_2010_MC_2
- Status last verified
- Aug 2019
- First submitted
- 5 Apr 2013
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Clinical Trial, The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male
- ClinicalTrials.gov ID
- NCT01840982
- Acronym / sponsor ID
- CTCF2_2010_MC_2
- Conditions
- Healthy People, Diabetes Mellitus, Type 2
- Keywords
- Mixed grains, Glycemic index, Giant embryonic brown rice, Giant embryonic rice, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- 25 Mar 2015 (actual)
- First posted
- 26 Apr 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, 4-treatment, 5-sequence, 5-day cross-over randomized design clinical trial to evaluate the efficacy of mixed grain on blood glucose, insulin and Glycemic index(GI) in healthy males.
Detailed description
After a 12-hour fast, oral glucose or meal tolerance test was performed with blood samples drawn at time 0, 15, 30, 45, 90, 120, 150, and 180 min.
- Serum levels of glucose, insulin, and C-peptide were analyzed by biochemical autoanalyzer. The area under the curve (AUC) changes in blood glucose 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Giant embryonic brown rice | Experimental | Dietary Supplement: Mixed grain 1 |
| Giant embryonic rice | Experimental | Dietary Supplement: Mixed grain 2 |
| White rice | Active comparator | Dietary Supplement: White rice |
| Glucose solution | Active comparator | Other: Glucose solution |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males, 19~60years old
- Bodyweight was more than 50 kg with ideal body weight within ±30%
- Less than 100 mg/dl in fasting blood glucose and less than 140 mg/dl in an oral glucose tolerance test (OGTT)
- 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 |
|---|---|---|
| Mixed grain 1Also: Mixed grain 1 (Giant embryonic brown rice) dietAll test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min. | Dietary supplement | Giant embryonic brown rice |
| Mixed grain 2Also: Mixed grain 2 (Giant embryonic rice) dietAll test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min. | Dietary supplement | Giant embryonic rice |
| White riceAlso: control dietAll test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min. | Dietary supplement | White rice |
| Glucose solutionAlso: Reference dietAll test foods contained 50 g available carbohydrate from the test food products. | Other | Glucose solution |
Primary outcome
1. Glycemic index(GI) 2. Glucose, insulin AUC(incremental area under the curve) 3. C-peptide
Time frame: 2 hour postprandial blood glucose, insulin, c-peptide
1. 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. 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. 3. Plasma c-peptide will be measured at baseline, 120 minutes post ingestion of each test solution.
1 secondary outcome
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)
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 7 Aug 2019.
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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 Mixed grain 1, Mixed grain 2 and White rice in people with Healthy People and Diabetes Mellitus, Type 2, 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 4 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 7 Aug 2019. 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. Glycemic index(GI) 2. Glucose, insulin AUC(incremental area under the curve) 3. C-peptide (time frame: 2 hour postprandial blood glucose, insulin, c-peptide). 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 7 Aug 2019.