Diabetes Mellitus, Type 2NCT04115592
The Effect of Different States of Lipid in Food on Glycaemia, Lipaemia and Insulinaemia.
A study testing Cocoa butter, Cocoa butter oleogel and Sal seed oil in people with Diabetes Mellitus, Type 2 and Cardiovascular Risk Factor, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
The aim of this study is to investigate if the application of lipid in various form (i.e. liquid and solid) affects glycaemia, lipaemia and insulinaemia. In addition, this study aims to test the lipidemic effects of the use of vegetable oil as a substitute in the application for making chocolate confectionery. 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
- Diabetes Mellitus, Type 2, Cardiovascular Risk Factor
- What is being tested?
- Cocoa butter, Cocoa butter oleogel and Sal seed oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Feb 2019to 9 Mar 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males
- Healthy Asian Chinese
- Aged between 21 - 40 years
- ≥45kg body weight
- Body mass index between 18.5 to 25.0 kg/m2
- Normal blood pressure ≤140/90 mmHg
- Fasting blood glucose <5.6 mmol/L
Who cannot join
- Smoking
- Allergic/intolerant to any of the test foods to be administered, or any of the following common food and ingredients: eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc.
- Anyone with intentional food restrictions
- People with known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Having metabolic or cardiovascular diseases (such as diabetes, hypertension, heart condition, etc.), Having any other diseases involving the small intestine or the colon (e.g., irritable bowel syndrome, inflammatory bowel disease, gastric reflux) or having any liver or kidney disorders or any family history of kidney stones
- Having medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
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- Taking any prescribed medication or dietary supplements which may interfere with the study measurements
- Individuals who have any major organ dysfunction (eg. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug
- Excessive alcohol consumption: consuming ≥ 6 alcoholic drinks per week
- 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)
- Have active Tuberculosis (TB) or currently receiving treatment for TB
- Individuals who partake in sports at the competitive and/or endurance levels
- 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
The aim of this study is to investigate if the application of lipid in various form (i.e. liquid and solid) affects glycaemia, lipaemia and insulinaemia. In addition, this study aims to test the lipidemic effects of the use of vegetable oil as a substitute in the application for making chocolate confectionery.
Read the detailed description
The study will have a randomized, non-blinded, crossover design. This study will explicitly compare the effects of different forms of fat (liquid and solid) on glucose, insulin and lipid response on 20 healthy male participants between the age of 21-40 years. In addition, this study aims to test the lipidemic effects of the use of vegetable oil as a substitute in the application for making chocolate confectionery.
All potential participants will be asked to attend four testing sessions and a screening session in total. During the first screening session, participants will receive an informed consent form and given ample time to go through it and rectify any queries they have. If they decide to take part in the study, they will be asked to sign the informed consent form. They will then be asked to complete a screening questionnaire, baseline measurements including anthropometric measurements, blood pressure, and fasting blood glucose will be collected from each participant in order to determine their eligibility. During the test sessions, participants' glycaemic, insulinaemic and lipaemic responses to the test meals will be measured. The test duration for each session will be 6.5 hours. Participants will be instructed to avoid strenuous physical activity for at least 3 days and avoid caffeine and alcohol consumption for at least 1 day prior to visiting the CNRC for their study trials. Participants will be provided with a standardized dinner meal (consisting of rice/noodles, vegetables, meat, drink/pudding) and to refrain from alcohol and exercise the day before their testing sessions.
Screening questionnaire: The screening questionnaire will include contact information, demographic and general health details. 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. Blood pressure will also be measured. All measurements will be taken in duplicate during the screening session. 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. Biceps and triceps skinfold measurements will also be taken. 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.
Blood collection: Participants will be asked to attend the testing sessions after an overnight fast of ten hours. At the beginning of the testing session, a cannula will be inserted into participants' arms. One fasting blood sample will be collected by venous cannulation. 3 milliliters (ml) of venous blood will be collected into Vacutainers® (Belton Dickinson Diagnostics) containing disodium EDTA for the analyses of plasma triglyceride, glucose and insulin concentrations. Participants will then consume treatment meal within 15 minutes. Blood samples will be taken at baseline, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 minutes. The amount of blood that will be collected at every time point will be approximately 3ml. A maximum of 15 blood samples will be collected by cannulation. A total of 180ml of blood will be taken for the study. Glycaemic, insulinaemic, and lipaemic responses will be determined using the method described by Wolever and Jenkins. The area under the curve will be determined as the area of those increments above baseline only.
Test session: Participants will be provided a standard dinner meal to be consumed at home at 7pm the night before the test session. Afterwhich, they will be asked to not eat and drink anything except water after 10:30 pm. They will also be instructed to arrive at the CNRC the following morning after an overnight fast of 10-12 hours. After 10 minutes upon arrival, an indwelling catheter will be inserted into a vein in your forearm and will be kept patent (free of clots) for the remainder of the test session. We will then take a blood sample from the cannula to measure baseline values. After obtaining the baseline blood samples, participants will be given the test meal to consume within 15 minutes. Following the test meal, we will take further blood samples (from the cannula) for the next 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360 minutes. The cannula will be removed after the last time-point of blood sample collection (360 minutes) and they are free to leave CNRC. During the entire testing period the participants will be instructed to remain rested and in the laboratory. There will be no incidental findings as analysed samples are basic metabolites and therefore, reporting is not applicable.
- Being tested
- Cocoa butter, Cocoa butter oleogel, Sal seed oil, Sal seed oleogel
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa butterOther
Consumption of cocoa butter made with chocolate confectionery
Cocoa butter oleogelOther
Consumption of cocoa butter oleogel made with chocolate confectionery
Sal seed oilOther
Consumption of sal seed oil made with chocolate confectionery
Sal seed oleogelOther
Consumption of sal seed oleogel made with chocolate confectionery
| Study group | Role | What they receive |
|---|---|---|
| Liquid oil type 1 | Experimental | Cocoa butter (CB) Receives: Other: Cocoa butter |
| Solid oil type 1 | Experimental | Cocoa butter oleogel (CBOG) Receives: Other: Cocoa butter oleogel |
| Liquid oil type 2 | Experimental | Sal seed oil (SL) Receives: Other: Sal seed oil |
| Solid oil type 2 | Experimental | Sal seed oleogel (SLOG) Receives: Other: Sal seed oleogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial triglycerides
Venous blood plasma measured using the COBAS
Measured: From 0 to 360 minutes
Postprandial glucose
Venous blood plasma measured using the COBAS
Measured: From 0 to 360 minutes
Secondary outcomes (1)
Postprandial insulin
Venous blood plasma measured using the COBAS
Measured: From 0 to 360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start20 Feb 2019
- Primary completion16 Jan 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 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
- NCT04115592
- Sponsor's protocol ID
- 2018/01193
- Other IDs
- 2018
- Status last verified
- Aug 2021
- First submitted
- 3 Oct 2019
- Last updated
- 20 Aug 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 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different States of Lipid in Food on Glycaemia, Lipaemia and Insulinaemia.
- ClinicalTrials.gov ID
- NCT04115592
- Acronym / sponsor ID
- 2018/01193
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 4 Oct 2019 (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 this study is to investigate if the application of lipid in various form (i.e. liquid and solid) affects glycaemia, lipaemia and insulinaemia. In addition, this study aims to test the lipidemic effects of the use of vegetable oil as a substitute in the application for making chocolate confectionery.
Detailed description
The study will have a randomized, non-blinded, crossover design. This study will explicitly compare the effects of different forms of fat (liquid and solid) on glucose, insulin and lipid response on 20 healthy male participants between the age of 21-40 years. In addition, this study aims to test the lipidemic effects of the use of vegetable oil as a substitute in the application for making chocolate confectionery.
All potential participants will be asked to attend four testing sessions and a screening session in total. During the first screening session, participants will receive an informed consent form and given ample time to go through it and rectify any queries they have. If they decide to take part in the study, they will be asked to sign the informed consent form. They will then be asked to complete a screening questionnaire, baseline measurements including anthropometric measurements, blood pressure, and fasting blood glucose will be collected from each participant in order to determine their eligibility. During the test sessions, participants' glycaemic, insulinaemic and lipaemic responses to the test meals will be measured. The test duration for each session will be 6.5 hours. Participants will be instructed to avoid strenuous physical activity for at least 3 days and avoid caffeine and alcohol consumption for at least 1 day prior to visiting the CNRC for their study trials. Participants will be provided with a standardized dinner meal (consisting of rice/noodles, vegetables, meat, drink/pudding) and to refrain from alcohol and exercise the day before their testing sessions.
Screening questionnaire: The screening questionnaire will include contact information, demographic and general health details. 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. Blood pressure will also be measured. All measurements will be taken in duplicate during the screening session. 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. Biceps and triceps skinfold measurements will also be taken. 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.
Blood collection: Participants will be asked to attend the testing sessions after an overnight fast of ten hours. At the beginning of the testing session, a cannula will be inserted into participants' arms. One fasting blood sample will be collected by venous cannulation. 3 milliliters (ml) of venous blood will be collected into Vacutainers® (Belton Dickinson Diagnostics) containing disodium EDTA for the analyses of plasma triglyceride, glucose and insulin concentrations. Participants will then consume treatment meal within 15 minutes. Blood samples will be taken at baseline, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 minutes. The amount of blood that will be collected at every time point will be approximately 3ml. A maximum of 15 blood samples will be collected by cannulation. A total of 180ml of blood will be taken for the study. Glycaemic, insulinaemic, and lipaemic responses will be determined using the method described by Wolever and Jenkins. The area under the curve will be determined as the area of those increments above baseline only.
Test session: Participants will be provided a standard dinner meal to be consumed at home at 7pm the night before the test session. Afterwhich, they will be asked to not eat and drink anything except water after 10:30 pm. They will also be instructed to arrive at the CNRC the following morning after an overnight fast of 10-12 hours. After 10 minutes upon arrival, an indwelling catheter will be inserted into a vein in your forearm and will be kept patent (free of clots) for the remainder of the test session. We will then take a blood sample from the cannula to measure baseline values. After obtaining the baseline blood samples, participants will be given the test meal to consume within 15 minutes. Following the test meal, we will take further blood samples (from the cannula) for the next 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360 minutes. The cannula will be removed after the last time-point of blood sample collection (360 minutes) and they are free to leave CNRC. During the entire testing period the participants will be instructed to remain rested and in the laboratory. There will be no incidental findings as analysed samples are basic metabolites and therefore, reporting is not applicable.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Liquid oil type 1 | Experimental | Other: Cocoa butterCocoa butter (CB) |
| Solid oil type 1 | Experimental | Other: Cocoa butter oleogelCocoa butter oleogel (CBOG) |
| Liquid oil type 2 | Experimental | Other: Sal seed oilSal seed oil (SL) |
| Solid oil type 2 | Experimental | Other: Sal seed oleogelSal seed oleogel (SLOG) |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males
- Healthy Asian Chinese
- Aged between 21 - 40 years
- ≥45kg body weight
- Body mass index between 18.5 to 25.0 kg/m2
Key exclusion criteria (13 listed)
- Smoking
- Allergic/intolerant to any of the test foods to be administered, or any of the following common food and ingredients: eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc.
- Anyone with intentional food restrictions
- People with known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Having metabolic or cardiovascular diseases (such as diabetes, hypertension, heart condition, etc.), Having any other diseases involving the small intestine or the colon (e.g., irritable bowel syndrome, inflammatory bowel disease, gastric reflux) or having any liver or kidney disorders or any family history of kidney stones
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 |
|---|---|---|
| Cocoa butterConsumption of cocoa butter made with chocolate confectionery | Other | Liquid oil type 1 |
| Cocoa butter oleogelConsumption of cocoa butter oleogel made with chocolate confectionery | Other | Solid oil type 1 |
| Sal seed oilConsumption of sal seed oil made with chocolate confectionery | Other | Liquid oil type 2 |
| Sal seed oleogelConsumption of sal seed oleogel made with chocolate confectionery | Other | Solid oil type 2 |
Primary outcome
Postprandial triglycerides
Time frame: From 0 to 360 minutes
Venous blood plasma measured using the COBAS
Postprandial glucose
Time frame: From 0 to 360 minutes
Venous blood plasma measured using the COBAS
1 secondary outcome
Postprandial insulin
Time frame: From 0 to 360 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 20 Aug 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 Cocoa butter, Cocoa butter oleogel and Sal seed oil in people with Diabetes Mellitus, Type 2 and Cardiovascular Risk Factor, 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 7 inclusion and 13 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 20 Aug 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?
Postprandial triglycerides (time frame: From 0 to 360 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 20 Aug 2021.