Diabetes MellitusNCT03020485
The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants
A study testing Isomaltulose and Sucrose in people with Diabetes Mellitus, run by Singapore Institute of Food and Biotechnology Innovation.
Trial summary
The objective of this study is to determine the glycaemic effect of isomaltulose and sucrose in Chinese, Indian, Malay, and Caucasian individuals. The current study will provide important information on the potential health benefits of isomaltulose consumption in Asian population. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Isomaltulose and Sucrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Sep 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese, Indian, Malay or Caucasian ethnic origin
Who cannot join
- People with major chronic disease such as heart disease, cancer or diabetes mellitus
- Individuals with food intolerances or allergies to isomaltulose or sucrose
- Individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution
- People with a major medical or surgical event requiring hospitalization within the preceding 3 months
- Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
- Pregnant women
About this study
The objective of this study is to determine the glycaemic effect of isomaltulose and sucrose in Chinese, Indian, Malay, and Caucasian individuals. The current study will provide important information on the potential health benefits of isomaltulose consumption in Asian population. It will also reveal how the three main ethnicities in Singapore respond to isomaltulose and whether the response differs from the Caucasians.
Read the detailed description
The objective of the present study is to investigate the glycaemic effect of isomaltulose in Chinese, Indians, Malays and Caucasians. This will be a single intervention. Up to fifty participants, consisting of at least ten Chinese, ten Malays, ten Indians, and ten Caucasians completed data sets, aged between 21 and 40 years will be recruited from the general public in Singapore. Participants will be asked to attend two test sessions for this study. Participants will consume either a sucrose drink or an isomaltulose drink (each containing 50 g of available carbohydrate).
- Conditions
- Diabetes Mellitus
- Being tested
- Isomaltulose, Sucrose
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsomaltuloseOther
Isomaltulose is a disaccharide made up of one molecule glucose and fructose with a (α1-6) linkage.
SucroseOther
Sucrose is normal table sugar
| Study group | Role | What they receive |
|---|---|---|
| Isomaltulose | Experimental | 50g of isomaltulose dissolved in 250ml of water Receives: Other: Isomaltulose |
| Sucrose | Experimental | 50g of sucrose dissolved in 250ml of water Receives: Other: Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post prandial Blood glucose for 180 minutes period
Blood glucose obtained through finger pricks using Hemocue Glucose 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 posted13 Jan 2017 (estimated)
- Study startDec 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Melvin Leow, Singapore Institute of Food and Biotechnology Innovation
- Investigators
- Melvin Leow, MD, Principal investigator, Clinical Nutrition Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020485
- Sponsor's protocol ID
- 2014/01008
- Other IDs
- 2014
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants
- ClinicalTrials.gov ID
- NCT03020485
- Acronym / sponsor ID
- 2014/01008
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- Dec 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 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.
The objective of this study is to determine the glycaemic effect of isomaltulose and sucrose in Chinese, Indian, Malay, and Caucasian individuals. The current study will provide important information on the potential health benefits of isomaltulose consumption in Asian population. It will also reveal how the three main ethnicities in Singapore respond to isomaltulose and whether the response differs from the Caucasians.
Detailed description
The objective of the present study is to investigate the glycaemic effect of isomaltulose in Chinese, Indians, Malays and Caucasians. This will be a single intervention. Up to fifty participants, consisting of at least ten Chinese, ten Malays, ten Indians, and ten Caucasians completed data sets, aged between 21 and 40 years will be recruited from the general public in Singapore. Participants will be asked to attend two test sessions for this study. Participants will consume either a sucrose drink or an isomaltulose drink (each containing 50 g of available carbohydrate).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isomaltulose | Experimental | Other: Isomaltulose50g of isomaltulose dissolved in 250ml of water |
| Sucrose | Experimental | Other: Sucrose50g of sucrose dissolved in 250ml of water |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Chinese, Indian, Malay or Caucasian ethnic origin
Key exclusion criteria (6 listed)
- People with major chronic disease such as heart disease, cancer or diabetes mellitus
- Individuals with food intolerances or allergies to isomaltulose or sucrose
- Individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution
- People with a major medical or surgical event requiring hospitalization within the preceding 3 months
- Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
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 |
|---|---|---|
| IsomaltuloseIsomaltulose is a disaccharide made up of one molecule glucose and fructose with a (α1-6) linkage. | Other | Isomaltulose |
| SucroseSucrose is normal table sugar | Other | Sucrose |
Primary outcome
Change in post prandial Blood glucose for 180 minutes period
Time frame: 180 minutes
Blood glucose obtained through finger pricks using Hemocue Glucose Analyser
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 13 Jan 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.
Melvin Leow, MD principal investigator
Clinical Nutrition Research Centre
Questions about this trial
What is this clinical trial studying?
A study testing Isomaltulose and Sucrose in people with Diabetes Mellitus, 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 1 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 13 Jan 2017. 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?
Change in post prandial Blood glucose for 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 13 Jan 2017.