HealthyNCT02585427
Effects of Co-ingesting a Low/High GI Meal With Different Fat Saturation on Postprandial Glucose, Insulin, and Triacylglycerol Responses in Healthy Participants
A study testing low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil in people with Healthy, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
It is now recognized that diet plays a critical role in the etiology and management of the chronic diseases such as diabetes, obesity and cardiovascular disease. A high consumption of fat, especially saturated fat, is an established risk factor for Cardiovascular Disease.The glycaemic index (GI) is a measurement of… 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
- Healthy
- What is being tested?
- low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2014to Apr 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Chinese male subjects aged between 21 and 40 years
- Do not have major chronic disease such as heart disease, cancer or diabetes mellitus
- Do not have family history of diabetes
- Do not have intolerances or allergies to test products(wheat and milk based products)
- Not taking insulin or drugs known to affect glucose or triglyceride levels and body fat distribution
- Do not have major medical or surgical event requiring hospitalization within the preceding three months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
It is now recognized that diet plays a critical role in the etiology and management of the chronic diseases such as diabetes, obesity and cardiovascular disease. A high consumption of fat, especially saturated fat, is an established risk factor for Cardiovascular Disease.The glycaemic index (GI) is a measurement of the ability of different types of carbohydrate-based foods to raise blood glucose. The interest in low GI food as a weight management tool has been increasing. Different types of carbohydrates differ in their ability to increase postprandial blood glucose and insulin secretion, and may also modulate the effect of different fatty acids. The current study will compare the consumption of low and high GI carbohydrate with different fat saturation on postprandial glucose, insulin, and triacylglycerol responses in healthy participants.
The data generated will have direct applications in public health policy and clinical nutrition management of chronic disease. The outcomes of the study will significantly contribute to the long term national goals of Singapore to manage and to reduce the incidence of chronic disease associated with the metabolic syndrome.
Read the detailed description
This study will be conducted using a randomized, crossover design with six dietary phases: a low GI meal or a high GI meal with saturated fat, monounsaturated fat or polyunsaturated fat. All participants will be randomly allocated to the six test meals, with the order balanced. Fifteen participants aged between 21 and 40 years will be recruited from the general public in Singapore. During the testing session, a maximum of eleven blood samples will be collected by fingerpricks and cannulation. Fingerpricks and cannulation may cause minor discomfort and there may be some slight bruising around the site. Fingerpricks and cannulation will be done by an experienced research nurse or a trained research officer to minimize participant discomfort. If bruising does occur, it should disappear within one day and it should not affect participants' regular daily activity. Participants will be limited to a maximum of two tests per week. In addition, blood collection will be carried out in a sterile designated area and thus the risk of infection will be very low. On rare occasions, participants may feel unwell during or after the testing session. The investigators have several metabolic suites with beds for these individuals to rest on. The research nurse and research officers will monitor the individuals' condition and they will be provided with a ride home if required.
All the study foods will be prepared in a hygienic manner in a purpose-built research kitchen maintained to the highest hygiene standards. The research staff has undergone basic training in food hygiene procedures. Hence, the risk of infective acute gastroenteritis will be minimal.
A number of dietary interventions have aimed to investigate the effect of dietary fat quality on glucose, insulin and lipidemia response. Up to now there have been few studies connect the glycaemic load and fat quality together. The investigators study's results will help public choose fat quality and carbohydrate quality in the diet. Participants will be provided with some snacks at the end of each testing session.
In addition, participants will be provided with their blood glucose, blood insulin, blood lipid profile, blood pressure, and body composition results, with a brief interpretation of these at the conclusion of the study.
- Conditions
- Healthy
- Being tested
- low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil
- Keywords
- Diabetes, Obesity, metabolic disorders
- Medical subject headings
- Diabetes Mellitus, Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| low glycemic index rice with butter | Experimental | 50 g available low glycemic index rice cooked with 48 g butter ( equal 40 g saturated fatty acid) Receives: Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil |
| low glycemic index rice with olive oil | Experimental | 50 g available low glycemic index rice cooked with 44 g olive oil ( equal 40 g monounsaturated fatty acid) Receives: Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil |
| low glycemic index rice with grapeseed oil | Experimental | 50 g available low glycemic index rice cooked with 40 g grapeseed oil ( equal 40 g polyunsaturated fatty acid) Receives: Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil |
| high glycemic index rice with butter | Experimental | 50 g available high glycemic index rice cooked with 48 g butter ( equal 40 g saturated fatty acid) Receives: Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil |
| high glycemic index rice with olive oil | Experimental | 50 g available high glycemic index rice cooked with 44 g olive oil ( equal 40 g monounsaturated fatty acid) Receives: Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil |
| high glycemic index rice with grapeseed oil | Experimental | 50 g available high glycemic index rice cooked with 40 g grapeseed oil ( equal 40 g polyunsaturated fatty acid) Receives: Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose response of different treatments
The blood glucose will be measured by finger prick and venous blood collection at the same time points
Measured: 4 hours postprandial
Insulin response of different treatments
Insulin concentration will be measured by COBAS Roche analyzer e311
Measured: 4 hours postprandial
Triglycerides response of different treatments
Triglycerides will be measured by COBAS Roche analyzer e411
Measured: 4 hours postprandial
Secondary outcomes (2)
Active Glucagon-like peptide 1 response of different treatments
Active Glucagon-like peptide 1 will be measured by Multiplex kits
Measured: 4 hours postprandial
Gastric inhibitory polypeptide response of different treatments
Gastric inhibitory polypeptide will be measured by Multiplex kits
Measured: 4 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startNov 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585427
- Sponsor's protocol ID
- 2014/00719
- Other IDs
- 2014
- Status last verified
- Aug 2016
- First submitted
- 14 Oct 2015
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sun L, Tan KWJ, Lim JZ, Magkos F, Henry CJ. Dietary fat and carbohydrate quality have independent effects on postprandial glucose and lipid responses. Eur J Nutr. 2018 Feb;57(1):243-250. doi: 10.1007/s00394-016-1313-y. Epub 2016 Oct 21.
PubMed 27770188
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Co-ingesting a Low/High GI Meal With Different Fat Saturation on Postprandial Glucose, Insulin, and Triacylglycerol Responses in Healthy Participants
- ClinicalTrials.gov ID
- NCT02585427
- Acronym / sponsor ID
- 2014/00719
- Conditions
- Healthy
- Keywords
- Diabetes, Obesity, metabolic disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Oct 2015 (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.
It is now recognized that diet plays a critical role in the etiology and management of the chronic diseases such as diabetes, obesity and cardiovascular disease. A high consumption of fat, especially saturated fat, is an established risk factor for Cardiovascular Disease.The glycaemic index (GI) is a measurement of the ability of different types of carbohydrate-based foods to raise blood glucose. The interest in low GI food as a weight management tool has been increasing. Different types of carbohydrates differ in their ability to increase postprandial blood glucose and insulin secretion, and may also modulate the effect of different fatty acids. The current study will compare the consumption of low and high GI carbohydrate with different fat saturation on postprandial glucose, insulin, and triacylglycerol responses in healthy participants.
The data generated will have direct applications in public health policy and clinical nutrition management of chronic disease. The outcomes of the study will significantly contribute to the long term national goals of Singapore to manage and to reduce the incidence of chronic disease associated with the metabolic syndrome.
Detailed description
This study will be conducted using a randomized, crossover design with six dietary phases: a low GI meal or a high GI meal with saturated fat, monounsaturated fat or polyunsaturated fat. All participants will be randomly allocated to the six test meals, with the order balanced. Fifteen participants aged between 21 and 40 years will be recruited from the general public in Singapore. During the testing session, a maximum of eleven blood samples will be collected by fingerpricks and cannulation. Fingerpricks and cannulation may cause minor discomfort and there may be some slight bruising around the site. Fingerpricks and cannulation will be done by an experienced research nurse or a trained research officer to minimize participant discomfort. If bruising does occur, it should disappear within one day and it should not affect participants' regular daily activity. Participants will be limited to a maximum of two tests per week. In addition, blood collection will be carried out in a sterile designated area and thus the risk of infection will be very low. On rare occasions, participants may feel unwell during or after the testing session. The investigators have several metabolic suites with beds for these individuals to rest on. The research nurse and research officers will monitor the individuals' condition and they will be provided with a ride home if required.
All the study foods will be prepared in a hygienic manner in a purpose-built research kitchen maintained to the highest hygiene standards. The research staff has undergone basic training in food hygiene procedures. Hence, the risk of infective acute gastroenteritis will be minimal.
A number of dietary interventions have aimed to investigate the effect of dietary fat quality on glucose, insulin and lipidemia response. Up to now there have been few studies connect the glycaemic load and fat quality together. The investigators study's results will help public choose fat quality and carbohydrate quality in the diet. Participants will be provided with some snacks at the end of each testing session.
In addition, participants will be provided with their blood glucose, blood insulin, blood lipid profile, blood pressure, and body composition results, with a brief interpretation of these at the conclusion of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| low glycemic index rice with butter | Experimental | Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil50 g available low glycemic index rice cooked with 48 g butter ( equal 40 g saturated fatty acid) |
| low glycemic index rice with olive oil | Experimental | Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil50 g available low glycemic index rice cooked with 44 g olive oil ( equal 40 g monounsaturated fatty acid) |
| low glycemic index rice with grapeseed oil | Experimental | Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil50 g available low glycemic index rice cooked with 40 g grapeseed oil ( equal 40 g polyunsaturated fatty acid) |
| high glycemic index rice with butter | Experimental | Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil50 g available high glycemic index rice cooked with 48 g butter ( equal 40 g saturated fatty acid) |
| high glycemic index rice with olive oil | Experimental | Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil50 g available high glycemic index rice cooked with 44 g olive oil ( equal 40 g monounsaturated fatty acid) |
| high glycemic index rice with grapeseed oil | Experimental | Dietary Supplement: low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil50 g available high glycemic index rice cooked with 40 g grapeseed oil ( equal 40 g polyunsaturated fatty acid) |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy Chinese male subjects aged between 21 and 40 years
- Do not have major chronic disease such as heart disease, cancer or diabetes mellitus
- Do not have family history of diabetes
- Do not have intolerances or allergies to test products(wheat and milk based products)
- Not taking insulin or drugs known to affect glucose or triglyceride levels and body fat distribution
Key exclusion criteria (0 listed)
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 glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil | Dietary supplement | high glycemic index rice with butter, high glycemic index rice with grapeseed oil, high glycemic index rice with olive oil, low glycemic index rice with butter, low glycemic index rice with grapeseed oil, low glycemic index rice with olive oil |
Primary outcome
Glucose response of different treatments
Time frame: 4 hours postprandial
The blood glucose will be measured by finger prick and venous blood collection at the same time points
Insulin response of different treatments
Time frame: 4 hours postprandial
Insulin concentration will be measured by COBAS Roche analyzer e311
Triglycerides response of different treatments
Time frame: 4 hours postprandial
Triglycerides will be measured by COBAS Roche analyzer e411
2 secondary outcomes
Active Glucagon-like peptide 1 response of different treatments
Time frame: 4 hours postprandial
Gastric inhibitory polypeptide response of different treatments
Time frame: 4 hours postprandial
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 2016.
- Derived from this study: PubMed 27770188Sun L, Tan KWJ, Lim JZ, Magkos F, Henry CJ. Dietary fat and carbohydrate quality have independent effects on postprandial glucose and lipid responses. Eur J Nutr. 2018 Feb;57(1):243-250. doi: 10.1007/s00394-016-1313-y. Epub 2016 Oct 21.
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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 glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil in people with Healthy, 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 6 inclusion and 0 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 2016. 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 response of different treatments (time frame: 4 hours postprandial). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585427, which also lists 1 linked publication.
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 2016.