Type 2 DiabetesNCT03031886
Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods
A study testing low glycaemic index intervention and high glycaemic index intervention in people with Type 2 Diabetes and Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
Purpose: This study is carried out to determine the effect of GI on 24 hour blood glucose profiles and energy regulation in Asians when fed a normal diet modulated with sweeteners. 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?
- low glycaemic index intervention and high glycaemic index intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Jan 2016to 21 Jul 2017
- 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 28 kg/m2
- Normal blood pressure (<140/80 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
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: This study is carried out to determine the effect of GI on 24 hour blood glucose profiles and energy regulation in Asians when fed a normal diet modulated with sweeteners.
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. The research sets out to determine the effect of GI on 24 hour blood glucose profiles and energy regulation in Asians. Healthy, normal-weight and overweight, Chinese males will be recruited. There will be two sessions (consisting of three days for each session) where they will consume either a high or low glycaemic index dinner at home and a high or low GI breakfast, lunch and snack on the next day (in the whole body calorimeter). There will be at least five days in between the two sessions. Their glycaemic response will be measured using a Continuous Glucose Monitoring System (CGMS) throughout the period, while substrate oxidation will be measured over 10 hours in the calorimeter (from breakfast, lunch and snack). This study specifically attempts to see whether the inclusion of a low GI sweetener in a mixed meal sequence can impact blood glucose levels and energy regulation in Asians. The study is important in that it will enable us to compute the rate of fat oxidation and how it is influenced when subjects are fed a mixed meals modulated to be high GI (increased glucose excursions) or low GI (moderated glucose) over 24 hours in healthy Asians. Obesity and diabetes rates are increasing exponentially in Asian populations and Singapore is no exception. Devising ways and means to staunch the escalation is therefore a priority. The findings of the research will contribute towards the long-term objectives of developing dietary guidelines for weight and glycaemic control. The study data will also be important for the provision of practical food-based advocacy for better weight and glycaemic control in Asians.
- Conditions
- Type 2 Diabetes, Obesity, PreDiabetes
- Being tested
- low glycaemic index intervention, high glycaemic index intervention
- 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.
low glycaemic index interventionOther
Low GI sweetener would be added to the treatment meals. 30 grams of isomaltulose to dinner and breakfast and 20 grams of isomaltulose to lunch and snack.
high glycaemic index interventionOther
High GI sweetener would be added to the treatment meals. 30 grams of sucrose to dinner and breakfast and 20 grams of sucrose to lunch and snack.
| Study group | Role | What they receive |
|---|---|---|
| high GI | Experimental | Cereal, milk, tea, cheese, steamed glutinous rice with chicken, carrots, bread, strawberry jam, margarine, high GI sweetener (sucrose). Receives: Other: high glycaemic index intervention |
| Low GI | Experimental | Cereal, milk, tea, steamed basmati rice with chicken, spinach, bread, strawberry jam, low GI sweetener (isomaltulose). Receives: Other: low glycaemic index intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic response
The blood glucose response to low and high GI test foods measured 2 hours post consumption using the Continuous Glucose Monitoring System (CGMS)
Measured: 3 hours post consumption
Daily blood glucose profile
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 for breakfast, lunch, snack and dinner.
Measured: 24 hours
substrate oxidation
Carbohydrate, fat and protein oxidation and respiratory quotient after consumption of low and high GI test foods are calculated for the 3 hours postprandial after breakfast, lunch and snack. These are calculated from the oxygen consumption, carbon dioxide production and nitrogen production. These sub-measurements are specified under: Other Pre-specified Outcomes: Oxygen consumption, carbon dioxide production, nitrogen production.
Measured: 3 hours post consumption
energy expenditure
Energy expenditure after consumption of low and high GI test foods is calculated for the 3 hours postprandial after breakfast, lunch and snack. This is calculated from the oxygen consumption and carbon dioxide production. These sub-measurements are specified under: Other Pre-specified Outcomes: Oxygen consumption, carbon dioxide production.
Measured: 3 hours post consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start20 Jan 2016
- Primary completion21 Jul 2017
- Study completion21 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized,crossover design with either a low or high GI diet with a 5 day washout period in between the 2 interventions..
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT03031886
- Sponsor's protocol ID
- 2015/01085
- Other IDs
- 2015
- Status last verified
- Jan 2017
- First submitted
- 19 Jan 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods
- ClinicalTrials.gov ID
- NCT03031886
- Acronym / sponsor ID
- 2015/01085
- Conditions
- Type 2 Diabetes, Obesity, PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 20 Jan 2016 (actual)
- Primary completion
- 21 Jul 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 26 Jan 2017 (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.
Purpose: This study is carried out to determine the effect of GI on 24 hour blood glucose profiles and energy regulation in Asians when fed a normal diet modulated with sweeteners.
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. The research sets out to determine the effect of GI on 24 hour blood glucose profiles and energy regulation in Asians. Healthy, normal-weight and overweight, Chinese males will be recruited. There will be two sessions (consisting of three days for each session) where they will consume either a high or low glycaemic index dinner at home and a high or low GI breakfast, lunch and snack on the next day (in the whole body calorimeter). There will be at least five days in between the two sessions. Their glycaemic response will be measured using a Continuous Glucose Monitoring System (CGMS) throughout the period, while substrate oxidation will be measured over 10 hours in the calorimeter (from breakfast, lunch and snack). This study specifically attempts to see whether the inclusion of a low GI sweetener in a mixed meal sequence can impact blood glucose levels and energy regulation in Asians. The study is important in that it will enable us to compute the rate of fat oxidation and how it is influenced when subjects are fed a mixed meals modulated to be high GI (increased glucose excursions) or low GI (moderated glucose) over 24 hours in healthy Asians. Obesity and diabetes rates are increasing exponentially in Asian populations and Singapore is no exception. Devising ways and means to staunch the escalation is therefore a priority. The findings of the research will contribute towards the long-term objectives of developing dietary guidelines for weight and glycaemic control. The study data will also be important for the provision of practical food-based advocacy for better weight and glycaemic control in Asians.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized,crossover design with either a low or high GI diet with a 5 day washout period in between the 2 interventions..
| Arm | Type | Receives |
|---|---|---|
| high GI | Experimental | Other: high glycaemic index interventionCereal, milk, tea, cheese, steamed glutinous rice with chicken, carrots, bread, strawberry jam, margarine, high GI sweetener (sucrose). |
| Low GI | Experimental | Other: low glycaemic index interventionCereal, milk, tea, steamed basmati rice with chicken, spinach, bread, strawberry jam, low GI sweetener (isomaltulose). |
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 28 kg/m2
- Normal blood pressure (<140/80 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 |
|---|---|---|
| low glycaemic index interventionLow GI sweetener would be added to the treatment meals. 30 grams of isomaltulose to dinner and breakfast and 20 grams of isomaltulose to lunch and snack. | Other | Low GI |
| high glycaemic index interventionHigh GI sweetener would be added to the treatment meals. 30 grams of sucrose to dinner and breakfast and 20 grams of sucrose to lunch and snack. | Other | high GI |
Primary outcome
Glycaemic response
Time frame: 3 hours post consumption
The blood glucose response to low and high GI test foods measured 2 hours post consumption using the Continuous Glucose Monitoring System (CGMS)
Daily blood glucose profile
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 for breakfast, lunch, snack and dinner.
substrate oxidation
Time frame: 3 hours post consumption
Carbohydrate, fat and protein oxidation and respiratory quotient after consumption of low and high GI test foods are calculated for the 3 hours postprandial after breakfast, lunch and snack. These are calculated from the oxygen consumption, carbon dioxide production and nitrogen production. These sub-measurements are specified under: Other Pre-specified Outcomes: Oxygen consumption, carbon dioxide production, nitrogen production.
energy expenditure
Time frame: 3 hours post consumption
Energy expenditure after consumption of low and high GI test foods is calculated for the 3 hours postprandial after breakfast, lunch and snack. This is calculated from the oxygen consumption and carbon dioxide production. These sub-measurements are specified under: Other Pre-specified Outcomes: Oxygen consumption, carbon dioxide production.
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 Aug 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low glycaemic index intervention and high glycaemic index intervention in people with Type 2 Diabetes and Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
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 2 Aug 2017. 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 Singapore. 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?
Glycaemic response (time frame: 3 hours post consumption). The study lists 4 primary outcomes in all. 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 Aug 2017.