Type 2 DiabetesNCT02340507
The Impact of the Glycaemic Index (GI) on Daily Blood Glucose Profiles and Food Intake in Young Chinese Adult Males
A study testing Rice and bread (high GI) and Rice and bread (low GI) in people with Type 2 Diabetes and Obesity, run by Singapore Institute of Food and Biotechnology Innovation.
Trial summary
This study is carried out to find out the inclusion of high and low glycaemic Index (GI) foods to daily meals impact on 24 hour blood glucose fluctuations and food intake. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity, Prediabetes
- What is being tested?
- Rice and bread (high GI) and Rice and bread (low GI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jan 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 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese, male
- Age between 21-40 years
- Body mass index between 17 to 24 kg/m2
- Normal blood pressure (120/80 Hgmm)
- Fasting blood glucose < 6 mmol/L
Who cannot join
- Having any metabolic diseases (such as diabetes, hypertension etc)
- One prescription medication
- Partaking in sports at the competitive and/or endurance levels
- Allergic/intolerant to any of the test foods
- Intentionally restricting food intake
- Smoking
About this study
This study is carried out to find out the inclusion of high and low glycaemic Index (GI) foods to daily meals impact on 24 hour blood glucose fluctuations and food intake.
Read the detailed description
The GI is a method of classifying foods based on the food's ability to raise the blood glucose level. Low GI foods are recommended as they have a lower impact on blood glucose concentrations and also reduce total food intake. There is very little information on how eating high and low GI foods affect daily blood glucose concentrations in Asians. Therefore, the objective of this study is to observe the effect of eating high and low GI breakfasts and snacks on 24 hour blood glucose concentrations and food consumption in Asian males. Healthy, normal-weight, Chinese males will be recruited. There will be two sessions (consisting of four days for each session) where they will consume either a high or low GI breakfast or snack, and a standardized ad libitum lunch buffet. Their glycaemic response will be measured using a Continuous Glucose Monitoring System (CGMS) throughout the period. The proposed research for the first time demonstrates how the consumption of high and low GI breakfasts and snacks affect subsequent energy intake and 24 hour blood glucose profiles in Asians. These findings will have significant public health benefits for optimum weight and dietary control.
- Conditions
- Type 2 Diabetes, Obesity, Prediabetes
- Being tested
- Rice and bread (high GI), Rice and bread (low GI)
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice and bread (high GI)Other
Rice is a high glycaemic index glutinous rice. Bread is a high glycaemic index white bread.
Rice and bread (low GI)Other
Rice is a low glycaemic index parboiled basmati rice. Bread is a low glycaemic index multigrain bread.
| Study group | Role | What they receive |
|---|---|---|
| High glycemic index | Experimental | The subject will consume a high glycemic index glutinous rice for breakfast (75g available carbohydrates), and a high glycemic index white bread for snack (25g available carbohydrates). The lunch is a standardized, weighed portion buffet. Receives: Other: Rice and bread (high GI) |
| Low glycemic index | Experimental | The subject will consume a low glycemic index parboiled basmati rice for breakfast (75g available carbohydrates), and a low glycemic index multigrain bread for snack (25g available carbohydrates). The lunch is a standardized, weighed portion buffet. Receives: Other: Rice and bread (low GI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic response (measured 3 hours post consumption using the Continuous Glucose Monitoring System (CGMS)
The blood glucose response to low and high GI test foods measured 3 hours post consumption using the Continuous Glucose Monitoring System (CGMS)
Measured: 3 hours post consumption
Daily blood glucose profile (easured for each low and high GI treatment as the area under the curve over 24 hours using CGMS)
The daily total blood glucose response is measured for each low and high GI treatment as the area under the curve over 24 hours using CGMS.
Measured: 24 hours
Secondary outcomes (1)
Energy intake (The amount of food consumed at the ad libitum lunch is measured by weighed quantities (in grams converted to kilocalories) based on the difference of the weight of food before and after consumption)
The amount of food consumed at the ad libitum lunch is measured by weighed quantities (in grams converted to kilocalories) based on the difference of the weight of food before and after consumption
Measured: Immediately post meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340507
- Sponsor's protocol ID
- 2013/00266
- Status last verified
- Mar 2015
- First submitted
- 7 Jan 2015
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaur B, Ranawana V, Teh AL, Henry CJK. The impact of a low glycemic index (GI) breakfast and snack on daily blood glucose profiles and food intake in young Chinese adult males. J Clin Transl Endocrinol. 2015 Jun 11;2(3):92-98. doi: 10.1016/j.jcte.2015.05.002. eCollection 2015 Sep.
PubMed 29204372
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Glycaemic Index (GI) on Daily Blood Glucose Profiles and Food Intake in Young Chinese Adult Males
- ClinicalTrials.gov ID
- NCT02340507
- Acronym / sponsor ID
- 2013/00266
- Conditions
- Type 2 Diabetes, Obesity, Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Jan 2015 (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 is carried out to find out the inclusion of high and low glycaemic Index (GI) foods to daily meals impact on 24 hour blood glucose fluctuations and food intake.
Detailed description
The GI is a method of classifying foods based on the food's ability to raise the blood glucose level. Low GI foods are recommended as they have a lower impact on blood glucose concentrations and also reduce total food intake. There is very little information on how eating high and low GI foods affect daily blood glucose concentrations in Asians. Therefore, the objective of this study is to observe the effect of eating high and low GI breakfasts and snacks on 24 hour blood glucose concentrations and food consumption in Asian males. Healthy, normal-weight, Chinese males will be recruited. There will be two sessions (consisting of four days for each session) where they will consume either a high or low GI breakfast or snack, and a standardized ad libitum lunch buffet. Their glycaemic response will be measured using a Continuous Glucose Monitoring System (CGMS) throughout the period. The proposed research for the first time demonstrates how the consumption of high and low GI breakfasts and snacks affect subsequent energy intake and 24 hour blood glucose profiles in Asians. These findings will have significant public health benefits for optimum weight and dietary control.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High glycemic index | Experimental | Other: Rice and bread (high GI)The subject will consume a high glycemic index glutinous rice for breakfast (75g available carbohydrates), and a high glycemic index white bread for snack (25g available carbohydrates). The lunch is a standardized, weighed portion buffet. |
| Low glycemic index | Experimental | Other: Rice and bread (low GI)The subject will consume a low glycemic index parboiled basmati rice for breakfast (75g available carbohydrates), and a low glycemic index multigrain bread for snack (25g available carbohydrates). The lunch is a standardized, weighed portion buffet. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chinese, male
- Age between 21-40 years
- Body mass index between 17 to 24 kg/m2
- Normal blood pressure (120/80 Hgmm)
- Fasting blood glucose < 6 mmol/L
Key exclusion criteria (6 listed)
- Having any metabolic diseases (such as diabetes, hypertension etc)
- One prescription medication
- Partaking in sports at the competitive and/or endurance levels
- Allergic/intolerant to any of the test foods
- Intentionally restricting food intake
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 |
|---|---|---|
| Rice and bread (high GI)Rice is a high glycaemic index glutinous rice. Bread is a high glycaemic index white bread. | Other | High glycemic index |
| Rice and bread (low GI)Rice is a low glycaemic index parboiled basmati rice. Bread is a low glycaemic index multigrain bread. | Other | Low glycemic index |
Primary outcome
Glycaemic response (measured 3 hours post consumption using the Continuous Glucose Monitoring System (CGMS)
Time frame: 3 hours post consumption
The blood glucose response to low and high GI test foods measured 3 hours post consumption using the Continuous Glucose Monitoring System (CGMS)
Daily blood glucose profile (easured for each low and high GI treatment as the area under the curve over 24 hours using CGMS)
Time frame: 24 hours
The daily total blood glucose response is measured for each low and high GI treatment as the area under the curve over 24 hours using CGMS.
1 secondary outcome
Energy intake (The amount of food consumed at the ad libitum lunch is measured by weighed quantities (in grams converted to kilocalories) based on the difference of the weight of food before and after consumption)
Time frame: Immediately post meal consumption
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 1 Apr 2015.
- Derived from this study: PubMed 29204372Kaur B, Ranawana V, Teh AL, Henry CJK. The impact of a low glycemic index (GI) breakfast and snack on daily blood glucose profiles and food intake in young Chinese adult males. J Clin Transl Endocrinol. 2015 Jun 11;2(3):92-98. doi: 10.1016/j.jcte.2015.05.002. eCollection 2015 Sep.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rice and bread (high GI) and Rice and bread (low GI) in people with Type 2 Diabetes and Obesity, run by Singapore Institute of Food and Biotechnology Innovation.
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 6 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 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Glycaemic response (measured 3 hours post consumption using the Continuous Glucose Monitoring System (CGMS) (time frame: 3 hours post consumption). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02340507, which also lists 1 linked publication.
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 1 Apr 2015.