DiabetesNCT03646812
Glycemic and Insulinemic Response of Pasta Products in Comparison to Asian Foods
A study testing Glucose Reference 1, Glucose Reference 2 and Glucose Reference 3 in people with Diabetes, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
The aim of the study is to determine the glycaemic and insulinaemic index of pasta products and local foods. It is hypothesized that different pasta cuts and wholegrain composition of pasta and local foods have different GI depending on the nature of the carbohydrate content and the food structure within each food. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Glucose Reference 1, Glucose Reference 2 and Glucose Reference 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Aug 2018to 1 Jun 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Asian - Indian and Chinese ethnicity
- Age between 21-40 years
- Body mass index between 18.5 to 25 kg/m2
- Normal blood pressure (<140/90 mmHg)
- Fasting blood glucose < 6 mmol/L
Who cannot join
- Is a current smoker
- Is currently pregnant
- Have any metabolic diseases (such as diabetes, hypertension etc)
- Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Have medical conditions and/or taking medications known to affect glycemia(glucocorticoids, thyroid hormones, thiazide diuretics)
- Have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug
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- Have any severe food allergy (e.g. anaphylaxis to peanuts)
- Have any known allergies to any food components of the study protocol
- Have active Tuberculosis (TB) or currently receiving treatment for TB
- Have any 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)
- Is a study team member or an immediate family of any study team member. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study.
- Have partake in sports at the competitive and/or endurance levels
- Have intentionally restrict food intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glycemic and Insulinemic Response of Pasta Products in Comparison to Asian
The aim of the study is to determine the glycaemic and insulinaemic index of pasta products and local foods. It is hypothesized that different pasta cuts and wholegrain composition of pasta and local foods have different GI depending on the nature of the carbohydrate content and the food structure within each food.
Read the detailed description
There will be a total of 9 test sessions and each session will last up to 3.5 hours. The order of sessions will be determined with an online randomizer. At each test session, the following procedures will be performed: two finger-prick blood samples, five minutes apart to measure baseline blood glucose and insulin concentrations Subject will be served the test food and to consume within15 minutes Following the test meal, blood samples will be collected at the following time points: 15, 30, 45, 60, 90, 120, 150 and 180min for glucose measurements and insulin measurements will be collected at 30, 60, 90, 120, 150 and 180min.
- Conditions
- Diabetes
- Being tested
- Glucose Reference 1, Glucose Reference 2, Glucose Reference 3, Semolina Penne, Wholegrain Penne
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose Reference 1Other
Glucose contains 50g of available carbohydrates
Glucose Reference 2Other
Glucose contains 50g of available carbohydrates
Glucose Reference 3Other
Glucose contains 50g of available carbohydrates
Semolina PenneOther
Semolina Penne contains 50g of available carbohydrates
Wholegrain PenneOther
Wholegrain Penne contains 50g of available carbohydrates
Semolina SpaghettiOther
Semolina Spaghetti contains 50g of available carbohydrates
Wholegrain SpaghettiOther
Wholegrain Spaghetti contains 50g of available carbohydrates
Jasmine RiceOther
Jasmine Rice contains 50g of available carbohydrates
Asian NoodlesOther
Asian Noodles contains 50g of available carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| Glucose Reference 1 | Other | 50g of glucose dissolved in 250ml of water to be consumed. Receives: Other: Glucose Reference 1 |
| Glucose Reference 2 | Other | 50g of glucose dissolved in 250ml of water to be consumed. Receives: Other: Glucose Reference 2 |
| Glucose Reference 3 | Other | 50g of glucose dissolved in 250ml of water to be consumed. Receives: Other: Glucose Reference 3 |
| Semolina Penne | Experimental | 70g of semolina penne boiled in 1 Litre of water for 11 minutes. Drained and consume immediately. Receives: Other: Semolina Penne |
| Wholegrain Penne | Experimental | 76g of wholegrain penne boiled in 1 Litre of water for 9 minutes. Drained and consume immediately. Receives: Other: Wholegrain Penne |
| Semolina Spaghetti | Experimental | 71g of semolina spaghetti boiled in 1 Litre of water for 8 minutes. Drained and consume immediately. Receives: Other: Semolina Spaghetti |
| Wholegrain Spaghetti | Experimental | 76g of wholegrain spaghetti boiled in 1 Litre of water for 8 minutes. Drained and consume immediately. Receives: Other: Wholegrain Spaghetti |
| Jasmine rice | Experimental | 63g of rice cook with 150g of water. Served and consume immediately. Receives: Other: Jasmine Rice |
| Asian Noodles | Experimental | 92.4g of Asian Noodles cook in boiling water for 45 seconds. Drained and consume immediately Receives: Other: Asian Noodles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Blood will be collected and measured using hemocue analyzer.
Measured: up to 180 minutes
Insulin
Blood will be collected and measured using COBAS analyzer.
Measured: up to 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start10 Aug 2018
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Collaborators
- Barilla Singapore Pte Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646812
- Sponsor's protocol ID
- 2018/00622
- Other IDs
- 2018
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2018
- Last updated
- 31 Aug 2023
- 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 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic and Insulinemic Response of Pasta Products in Comparison to Asian
- ClinicalTrials.gov ID
- NCT03646812
- Acronym / sponsor ID
- 2018/00622
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Collaborators
- Barilla Singapore Pte Ltd
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 24 Aug 2018 (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.
The aim of the study is to determine the glycaemic and insulinaemic index of pasta products and local foods. It is hypothesized that different pasta cuts and wholegrain composition of pasta and local foods have different GI depending on the nature of the carbohydrate content and the food structure within each food.
Detailed description
There will be a total of 9 test sessions and each session will last up to 3.5 hours. The order of sessions will be determined with an online randomizer. At each test session, the following procedures will be performed: two finger-prick blood samples, five minutes apart to measure baseline blood glucose and insulin concentrations Subject will be served the test food and to consume within15 minutes Following the test meal, blood samples will be collected at the following time points: 15, 30, 45, 60, 90, 120, 150 and 180min for glucose measurements and insulin measurements will be collected at 30, 60, 90, 120, 150 and 180min.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Glucose Reference 1 | Other | Other: Glucose Reference 150g of glucose dissolved in 250ml of water to be consumed. |
| Glucose Reference 2 | Other | Other: Glucose Reference 250g of glucose dissolved in 250ml of water to be consumed. |
| Glucose Reference 3 | Other | Other: Glucose Reference 350g of glucose dissolved in 250ml of water to be consumed. |
| Semolina Penne | Experimental | Other: Semolina Penne70g of semolina penne boiled in 1 Litre of water for 11 minutes. Drained and consume immediately. |
| Wholegrain Penne | Experimental | Other: Wholegrain Penne76g of wholegrain penne boiled in 1 Litre of water for 9 minutes. Drained and consume immediately. |
| Semolina Spaghetti | Experimental | Other: Semolina Spaghetti71g of semolina spaghetti boiled in 1 Litre of water for 8 minutes. Drained and consume immediately. |
| Wholegrain Spaghetti | Experimental | Other: Wholegrain Spaghetti76g of wholegrain spaghetti boiled in 1 Litre of water for 8 minutes. Drained and consume immediately. |
| Jasmine rice | Experimental | Other: Jasmine Rice63g of rice cook with 150g of water. Served and consume immediately. |
| Asian Noodles | Experimental | Other: Asian Noodles92.4g of Asian Noodles cook in boiling water for 45 seconds. Drained and consume immediately |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Asian - Indian and Chinese ethnicity
- Age between 21-40 years
- Body mass index between 18.5 to 25 kg/m2
- Normal blood pressure (<140/90 mmHg)
- Fasting blood glucose < 6 mmol/L
Key exclusion criteria (14 listed)
- Is a current smoker
- Is currently pregnant
- Have any metabolic diseases (such as diabetes, hypertension etc)
- Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Have medical conditions and/or taking medications known to affect glycemia(glucocorticoids, thyroid hormones, thiazide diuretics)
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 Reference 1Glucose contains 50g of available carbohydrates | Other | Glucose Reference 1 |
| Glucose Reference 2Glucose contains 50g of available carbohydrates | Other | Glucose Reference 2 |
| Glucose Reference 3Glucose contains 50g of available carbohydrates | Other | Glucose Reference 3 |
| Semolina PenneSemolina Penne contains 50g of available carbohydrates | Other | Semolina Penne |
| Wholegrain PenneWholegrain Penne contains 50g of available carbohydrates | Other | Wholegrain Penne |
| Semolina SpaghettiSemolina Spaghetti contains 50g of available carbohydrates | Other | Semolina Spaghetti |
| Wholegrain SpaghettiWholegrain Spaghetti contains 50g of available carbohydrates | Other | Wholegrain Spaghetti |
| Jasmine RiceJasmine Rice contains 50g of available carbohydrates | Other | Jasmine rice |
| Asian NoodlesAsian Noodles contains 50g of available carbohydrates | Other | Asian Noodles |
Primary outcome
Glucose
Time frame: up to 180 minutes
Blood will be collected and measured using hemocue analyzer.
Insulin
Time frame: up to 180 minutes
Blood will be collected and measured using COBAS analyzer.
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 31 Aug 2023.
- 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 Glucose Reference 1, Glucose Reference 2 and Glucose Reference 3 in people with Diabetes, 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 14 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 31 Aug 2023. 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?
Glucose (time frame: up to 180 minutes). 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?
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 31 Aug 2023.