Type 2 DiabetesNCT04653207
The Dose Effects of Isomaltulose and Sucrose on Glycaemic and Insulinemic Response
A study testing Glucose Solution 1, Glucose Solution 2 and Glucose Solution 3 in people with Type 2 Diabetes and Obesity, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
This study will determine the glycaemic and insulinaemic response and sensory profile of the drinks with various ratios sucrose:isomaltulose. The information will be useful for manufacturers of beverages to produce blood glucose friendlier drinks. Read more about this study
- Who is it for?
- Ages 21 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity, Pre Diabetes
- What is being tested?
- Glucose Solution 1, Glucose Solution 2 and Glucose Solution 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2018to 28 Oct 2020
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
- Males
- Asian selected from the three ethnicities Malay, Indian and Chinese
- Age between 21-60 years
- Do not partake in sports at the competitive and/or endurance levels
- Body mass index between 22 to 27 kg/m2
- Normal blood pressure (<140/80 mmHg)
- Fasting blood glucose <6 mmol/L
- Do not have an ongoing infection or currently undergoing treatment at the time of screening
- Do not have known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
- Do not have active Tuberculosis (TB) or currently receiving treatment for TB
- Not on any concurrent research study/trials
- Do not smoke
- Do not have any metabolic diseases (such as diabetes, hypertension etc)
- Do not have glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Not having medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
- Do not have intolerances or allergies to foods including the test foods and fructose
- Do not partake in sports at the competitive and/or endurance levels
- Do not intentionally restrict food intake
- Do not have an ongoing infection or currently undergoing treatment at the time of screening
- Do not have known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
- Do not have active Tuberculosis (TB) or currently receiving treatment for TB
- Not on any concurrent research study/trials • Do not smoke• Do not have any metabolic diseases (such as diabetes, hypertension etc)
- Do not have glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Not having medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)• Do not have intolerances or allergies to foods including the test foods and fructose
- Do not partake in sports at the competitive and/or endurance levels
- Do not intentionally restrict food intake
- Not a team member of the study or is an immediate family member (Immediate family defined as a spouse, parent, child, or sibling, whether biological or legally adopted)
Trial locations and contacts
1 site in 1 country.
About this study
This study will determine the glycaemic and insulinaemic response and sensory profile of the drinks with various ratios sucrose:isomaltulose. The information will be useful for manufacturers of beverages to produce blood glucose friendlier drinks. The information will also be useful for dieticians and clinicians in recommending foods and drinks for people with diabetes. The information will also be useful to the public for making better food choices. The data will also provide insights on how the different ratios of sweeteners may affect glycaemic and insulinaemic indices (GI and II).
Read the detailed description
The aim of the study is to determine the optimal mixture of sucrose with isomaltulose that will produce optimal reduction in glycaemia and an acceptable sensory profile. These will be assessed among three different ethnicities.The study will recruit a maximum of 60 healthy young (21-60 years old) males from three ethnicities (Malay, Indian, and Chinese). Each participant will take part in 9 separate test sessions on nonconsecutive days, and consume 3 reference control drinks and 6 different test drinks. On each of the test days, participants will consume either the reference drink (50g of anhydrous glucose dissolved in 300 ml of water) or one of the test drinks which consists of 50g of sucrose and/or isomaltulose dissolved in 300 ml of water in the following ratios: 0:100, 100:0, 50:50, 80:20, 70:30, 60:40 sucrose:isomaltulose. Study population: The study will recruit a maximum of 65 healthy young (21-60 years old) males. At least 10 participants will be selected from the three ethnicities (Malay, Indian, and Chinese). Males will be selected in order to avoid effects of the menstrual cycle. Participants will be recruited from the general public in Singapore and will be between 21 and 60 years, with a body mass index between 22 and 27 kg/m2.Design: The experimental protocol adopted is a pre-validated method used repeatedly for measuring the GI of foods. The testing follows a randomised, single-blinded, between-subjects, crossover design with participants returning on 9 non-consecutive days. Reference food testing (standard glucose solution) will precede test food testing. On each test day, participant will consume either the reference drink or one of the test drinks. The test sessions will be made up of 3 identical reference drinks and 6 test drinks. The number sessions each participant will complete will be determined by the researcher and communicated to the participant. For the 9 test sessions, participants arrive at the laboratory between 8:30-9 am following a 10 hour overnight fast. They are instructed not to partake in intense level sports and avoid alcohol consumption on the evening prior to a test session. Following a 10 minute rest two blood samples are obtained five minutes apart for determining baseline blood glucose levels. They are then given either the standard or test drink to consume. They are instructed to consume the food at a comfortable pace within 12 minutes. After consumption of the test drink, subjects will complete a liking questionnaire. Further blood samples are obtained at 15, 30, 45, 60, 90, 120, 150 and 180 minutes for blood glucose measurements and insulin (at every half hour intervals).Reference/Test foods: The reference drink will be anhydrous glucose (50 g) (standard) dissolved in 300 ml of water) and will be consumed on 3 occasions. The test drinks will consist of 50g of sucrose and/or isomaltulose dissolved in 300 ml of water in the following ratios: 0:100, 100:0, 50:50, 80:20, 70:30, 60:40 sucrose:isomaltulose. A total of 6 test drinks will be tested. The participant will be requested to finish both reference and test drink within 12min.Blood collection: Participants will be asked to attend the testing sessions after an overnight fast of ten to twelve hours. Two fasting blood samples will be collected by finger prick for glucose measurement and not more than 0.5ml finger prick blood sample will also be collected to measure baseline insulin. A drop of blood will be collected into a HemoCue® cuvette (Helsingborg, Sweden) for blood glucose analysis. In addition, not more than 0.5ml of finger prick blood will be collected for the analyses of plasma insulin concentrations. Participants will then consume the test meal within 12 minutes. Following this, approximately 5µl of blood samples will be collected at 15, 30, 45, 60, 90, 120, 150 and 180min for glucose measurements and not more than 0.5ml of blood samples will be collected at 30, 60, 90, 120, 150 and 180min for insulin measurements.'Liking' questionnaire: On the testing session days, participants will be asked to rate their 'liking' for the test meal. Participants will be rate their 'overall liking' for the test meal on a 100 mm Visual Analog Scale anchored with 'dislike extremely' (0 mm), 'neither like nor dislike' (50 mm) and 'like extremely' (100 mm) immediately after they consume the test meal.Screening: Potential participants will first attend a screening session for consenting and eligibility procedures. Participants will arrive in the morning following an overnight fast. During the screening, a questionnaire will have to be completed and anthropometry and blood pressure will be assessed. Screening questionnaire: The screening questionnaire will include contact information, demographic, general health details, and physical activity level. This information will be used to determine whether the participant is eligible for the study, as well as to check for any possible confounders that may influence the study outcomes. Anthropometric measurements: Body weight and body composition will be measured using bioelectrical impedance analysis. Height will be measured using a stadiometer in order to calculate participants' BMI. Waist circumference will be measured at the minimum circumference between the iliac crest and the rib cage. Hip circumference will be measured at the maximum protuberance of the buttocks. Blood pressure will also be measured. Blood pressure: Blood pressure will be measured using an Omron blood pressure monitor (Model HEM-907) at baseline. Participants will be seated for five minutes before blood pressure is measured. Measurements will be taken in duplicate and the averaged results will be recorded.
- Conditions
- Type 2 Diabetes, Obesity, Pre Diabetes
- Being tested
- Glucose Solution 1, Glucose Solution 2, Glucose Solution 3, Sucrose/Isomaltulose 100:0, Sucrose/Isomaltulose 0:100
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose Solution 1Other
50g glucose dissolve in 300ml of water
Glucose Solution 2Other
50g glucose dissolve in 300ml of water
Glucose Solution 3Other
50g glucose dissolve in 300ml of water
Sucrose/Isomaltulose 100:0Other
50g sucrose dissolve in 300ml of water
Sucrose/Isomaltulose 0:100Other
50g isomaltulose dissolve in 300ml of water
Sucrose/Isomaltulose 50:50Other
25g sucrose and 25g isomaltulose dissolve in 300ml of water
Sucrose/Isomaltulose 60:40Other
30g sucrose and 20g isomaltulose dissolve in 300ml of water
Sucrose/Isomaltulose 70:30Other
35g sucrose and 15g isomaltulose dissolve in 300ml of water
Sucrose/Isomaltulose 80:20Other
40g sucrose and 10g isomaltulose dissolve in 300ml of water
| Study group | Role | What they receive |
|---|---|---|
| Control 1 | Other | Glucose 50g Receives: Other: Glucose Solution 1 |
| Control 2 | Other | Glucose 50g Receives: Other: Glucose Solution 2 |
| Control 3 | Other | Glucose 50g Receives: Other: Glucose Solution 3 |
| Sucrose/Isomaltulose 100:0 | Experimental | A drink with 50g sucrose/isomaltulose 100:0 Receives: Other: Sucrose/Isomaltulose 100:0 |
| Sucrose/Isomaltulose 0:100 | Experimental | A drink with 50g sucrose/isomaltulose 0:100 Receives: Other: Sucrose/Isomaltulose 0:100 |
| Sucrose/Isomaltulose 50:50 | Experimental | A drink with 50g sucrose/isomaltulose 50:50 Receives: Other: Sucrose/Isomaltulose 50:50 |
| Sucrose/Isomaltulose 60:40 | Experimental | A drink with 50g sucrose/isomaltulose 60:40 Receives: Other: Sucrose/Isomaltulose 60:40 |
| Sucrose/Isomaltulose 70:30 | Experimental | A drink with 50g sucrose/isomaltulose 70:30 Receives: Other: Sucrose/Isomaltulose 70:30 |
| Sucrose/Isomaltulose 80:20 | Experimental | A drink with 50g sucrose/isomaltulose 80:20 Receives: Other: Sucrose/Isomaltulose 80:20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial blood glucose over 180 minutes period
Blood obtained through fingerprick, analysed using Hemocue analyser.
Measured: 180 minutes
Secondary outcomes (1)
Change in postprandial plasma insulin over 180 minutes period
Capillary plasma obtained through finger prick, analysed using Cobas analyser
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Mar 2018
- Primary completion28 Oct 2020
- Study completion28 Oct 2020
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
- Randomized crossover study
- Masking
- None (open label)
- Enrolment
- 64 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
- NCT04653207
- Sponsor's protocol ID
- 2018/00025
- Other IDs
- 2018
- Status last verified
- Dec 2021
- First submitted
- 27 Nov 2020
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose Effects of Isomaltulose and Sucrose on Glycaemic and Insulinemic Response
- ClinicalTrials.gov ID
- NCT04653207
- Acronym / sponsor ID
- 2018/00025
- Conditions
- Type 2 Diabetes, Obesity, Pre Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 4 Dec 2020 (actual)
- 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 will determine the glycaemic and insulinaemic response and sensory profile of the drinks with various ratios sucrose:isomaltulose. The information will be useful for manufacturers of beverages to produce blood glucose friendlier drinks. The information will also be useful for dieticians and clinicians in recommending foods and drinks for people with diabetes. The information will also be useful to the public for making better food choices. The data will also provide insights on how the different ratios of sweeteners may affect glycaemic and insulinaemic indices (GI and II).
Detailed description
The aim of the study is to determine the optimal mixture of sucrose with isomaltulose that will produce optimal reduction in glycaemia and an acceptable sensory profile. These will be assessed among three different ethnicities.The study will recruit a maximum of 60 healthy young (21-60 years old) males from three ethnicities (Malay, Indian, and Chinese). Each participant will take part in 9 separate test sessions on nonconsecutive days, and consume 3 reference control drinks and 6 different test drinks. On each of the test days, participants will consume either the reference drink (50g of anhydrous glucose dissolved in 300 ml of water) or one of the test drinks which consists of 50g of sucrose and/or isomaltulose dissolved in 300 ml of water in the following ratios: 0:100, 100:0, 50:50, 80:20, 70:30, 60:40 sucrose:isomaltulose. Study population: The study will recruit a maximum of 65 healthy young (21-60 years old) males. At least 10 participants will be selected from the three ethnicities (Malay, Indian, and Chinese). Males will be selected in order to avoid effects of the menstrual cycle. Participants will be recruited from the general public in Singapore and will be between 21 and 60 years, with a body mass index between 22 and 27 kg/m2.Design: The experimental protocol adopted is a pre-validated method used repeatedly for measuring the GI of foods. The testing follows a randomised, single-blinded, between-subjects, crossover design with participants returning on 9 non-consecutive days. Reference food testing (standard glucose solution) will precede test food testing. On each test day, participant will consume either the reference drink or one of the test drinks. The test sessions will be made up of 3 identical reference drinks and 6 test drinks. The number sessions each participant will complete will be determined by the researcher and communicated to the participant. For the 9 test sessions, participants arrive at the laboratory between 8:30-9 am following a 10 hour overnight fast. They are instructed not to partake in intense level sports and avoid alcohol consumption on the evening prior to a test session. Following a 10 minute rest two blood samples are obtained five minutes apart for determining baseline blood glucose levels. They are then given either the standard or test drink to consume. They are instructed to consume the food at a comfortable pace within 12 minutes. After consumption of the test drink, subjects will complete a liking questionnaire. Further blood samples are obtained at 15, 30, 45, 60, 90, 120, 150 and 180 minutes for blood glucose measurements and insulin (at every half hour intervals).Reference/Test foods: The reference drink will be anhydrous glucose (50 g) (standard) dissolved in 300 ml of water) and will be consumed on 3 occasions. The test drinks will consist of 50g of sucrose and/or isomaltulose dissolved in 300 ml of water in the following ratios: 0:100, 100:0, 50:50, 80:20, 70:30, 60:40 sucrose:isomaltulose. A total of 6 test drinks will be tested. The participant will be requested to finish both reference and test drink within 12min.Blood collection: Participants will be asked to attend the testing sessions after an overnight fast of ten to twelve hours. Two fasting blood samples will be collected by finger prick for glucose measurement and not more than 0.5ml finger prick blood sample will also be collected to measure baseline insulin. A drop of blood will be collected into a HemoCue® cuvette (Helsingborg, Sweden) for blood glucose analysis. In addition, not more than 0.5ml of finger prick blood will be collected for the analyses of plasma insulin concentrations. Participants will then consume the test meal within 12 minutes. Following this, approximately 5µl of blood samples will be collected at 15, 30, 45, 60, 90, 120, 150 and 180min for glucose measurements and not more than 0.5ml of blood samples will be collected at 30, 60, 90, 120, 150 and 180min for insulin measurements.'Liking' questionnaire: On the testing session days, participants will be asked to rate their 'liking' for the test meal. Participants will be rate their 'overall liking' for the test meal on a 100 mm Visual Analog Scale anchored with 'dislike extremely' (0 mm), 'neither like nor dislike' (50 mm) and 'like extremely' (100 mm) immediately after they consume the test meal.Screening: Potential participants will first attend a screening session for consenting and eligibility procedures. Participants will arrive in the morning following an overnight fast. During the screening, a questionnaire will have to be completed and anthropometry and blood pressure will be assessed. Screening questionnaire: The screening questionnaire will include contact information, demographic, general health details, and physical activity level. This information will be used to determine whether the participant is eligible for the study, as well as to check for any possible confounders that may influence the study outcomes. Anthropometric measurements: Body weight and body composition will be measured using bioelectrical impedance analysis. Height will be measured using a stadiometer in order to calculate participants' BMI. Waist circumference will be measured at the minimum circumference between the iliac crest and the rib cage. Hip circumference will be measured at the maximum protuberance of the buttocks. Blood pressure will also be measured. Blood pressure: Blood pressure will be measured using an Omron blood pressure monitor (Model HEM-907) at baseline. Participants will be seated for five minutes before blood pressure is measured. Measurements will be taken in duplicate and the averaged results will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- Randomized crossover study
| Arm | Type | Receives |
|---|---|---|
| Control 1 | Other | Other: Glucose Solution 1Glucose 50g |
| Control 2 | Other | Other: Glucose Solution 2Glucose 50g |
| Control 3 | Other | Other: Glucose Solution 3Glucose 50g |
| Sucrose/Isomaltulose 100:0 | Experimental | Other: Sucrose/Isomaltulose 100:0A drink with 50g sucrose/isomaltulose 100:0 |
| Sucrose/Isomaltulose 0:100 | Experimental | Other: Sucrose/Isomaltulose 0:100A drink with 50g sucrose/isomaltulose 0:100 |
| Sucrose/Isomaltulose 50:50 | Experimental | Other: Sucrose/Isomaltulose 50:50A drink with 50g sucrose/isomaltulose 50:50 |
| Sucrose/Isomaltulose 60:40 | Experimental | Other: Sucrose/Isomaltulose 60:40A drink with 50g sucrose/isomaltulose 60:40 |
| Sucrose/Isomaltulose 70:30 | Experimental | Other: Sucrose/Isomaltulose 70:30A drink with 50g sucrose/isomaltulose 70:30 |
| Sucrose/Isomaltulose 80:20 | Experimental | Other: Sucrose/Isomaltulose 80:20A drink with 50g sucrose/isomaltulose 80:20 |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Glucose Solution 150g glucose dissolve in 300ml of water | Other | Control 1 |
| Glucose Solution 250g glucose dissolve in 300ml of water | Other | Control 2 |
| Glucose Solution 350g glucose dissolve in 300ml of water | Other | Control 3 |
| Sucrose/Isomaltulose 100:050g sucrose dissolve in 300ml of water | Other | Sucrose/Isomaltulose 100:0 |
| Sucrose/Isomaltulose 0:10050g isomaltulose dissolve in 300ml of water | Other | Sucrose/Isomaltulose 0:100 |
| Sucrose/Isomaltulose 50:5025g sucrose and 25g isomaltulose dissolve in 300ml of water | Other | Sucrose/Isomaltulose 50:50 |
| Sucrose/Isomaltulose 60:4030g sucrose and 20g isomaltulose dissolve in 300ml of water | Other | Sucrose/Isomaltulose 60:40 |
| Sucrose/Isomaltulose 70:3035g sucrose and 15g isomaltulose dissolve in 300ml of water | Other | Sucrose/Isomaltulose 70:30 |
| Sucrose/Isomaltulose 80:2040g sucrose and 10g isomaltulose dissolve in 300ml of water | Other | Sucrose/Isomaltulose 80:20 |
Primary outcome
Change in postprandial blood glucose over 180 minutes period
Time frame: 180 minutes
Blood obtained through fingerprick, analysed using Hemocue analyser.
1 secondary outcome
Change in postprandial plasma insulin over 180 minutes period
Time frame: 180 minutes
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 23 Dec 2021.
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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 Glucose Solution 1, Glucose Solution 2 and Glucose Solution 3 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?
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 23 Dec 2021. 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?
Change in postprandial blood glucose over 180 minutes period (time frame: 180 minutes). 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 23 Dec 2021.