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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Singapore1 site
  • Clinical Nutrition Research Centre

    Singapore, 117599

Other trials in Singapore

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.

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 groups in NCT04653207
Study groupRoleWhat they receive
Control 1OtherGlucose 50g
Receives: Other: Glucose Solution 1
Control 2OtherGlucose 50g
Receives: Other: Glucose Solution 2
Control 3OtherGlucose 50g
Receives: Other: Glucose Solution 3
Sucrose/Isomaltulose 100:0ExperimentalA drink with 50g sucrose/isomaltulose 100:0
Receives: Other: Sucrose/Isomaltulose 100:0
Sucrose/Isomaltulose 0:100ExperimentalA drink with 50g sucrose/isomaltulose 0:100
Receives: Other: Sucrose/Isomaltulose 0:100
Sucrose/Isomaltulose 50:50ExperimentalA drink with 50g sucrose/isomaltulose 50:50
Receives: Other: Sucrose/Isomaltulose 50:50
Sucrose/Isomaltulose 60:40ExperimentalA drink with 50g sucrose/isomaltulose 60:40
Receives: Other: Sucrose/Isomaltulose 60:40
Sucrose/Isomaltulose 70:30ExperimentalA drink with 50g sucrose/isomaltulose 70:30
Receives: Other: Sucrose/Isomaltulose 70:30
Sucrose/Isomaltulose 80:20ExperimentalA 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.

  1. Change in postprandial blood glucose over 180 minutes period

    Blood obtained through fingerprick, analysed using Hemocue analyser.

    Measured: 180 minutes

Secondary outcomes (1)
  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.

  1. First posted4 Dec 2020
  2. Study start1 Mar 2018
  3. Primary completion28 Oct 2020
  4. Study completion28 Oct 2020

Resources

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)
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

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.

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