Metabolic DiseasesNCT02789683
Effects of Emulsification and Lipid Droplet Size on Postprandial Metabolic Responses
A study testing Fine emulsion and Coarse emulsion in people with Metabolic Diseases, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
The aim of this study is to compare the effects of emulsification and lipid droplet size on gastric emptying rate, and to determine if the change in gastric emptying rate can in turn influence postprandial glycemic, insulinemic and lipidemic responses. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases
- What is being tested?
- Fine emulsion and Coarse emulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2015to 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Chinese male subjects aged between 21 and 50 years
- Body mass index between 20.0 to 24.9 kg/m2
- Normal blood pressure (<140/90 mmHg)
- Fasting blood glucose <6.0 mmol/L
Who cannot join
- People with major chronic disease such as heart disease, cancer or diabetes mellitus
- People with family history of diabetes or familial cholesterolaemic
- People with history of liver or renal problems
- People who have intolerances or allergies to test products
- 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 three months
- Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Clinical Nutrition Research Centre
Singapore, Singapore, 117599
About this study
The aim of this study is to compare the effects of emulsification and lipid droplet size on gastric emptying rate, and to determine if the change in gastric emptying rate can in turn influence postprandial glycemic, insulinemic and lipidemic responses.
Read the detailed description
This study will be conducted using a randomized, crossover design with three dietary phases: 1) fine emulsion beverage (small lipid droplet size), 2) coarse emulsion beverage (large lipid droplet size) and 3) non-emulsified oil and water. All treatments will be consumed together with bread. All participants will be randomly allocated to the three test meals. Fifteen to twenty participants aged between 21 and 50 years will be recruited from the general public in Singapore.
During the testing sessions, participants' glycemic, insulinemic, lipidemic responses and gastric emptying to the test meals will be measured. Gastric antral distention ultrasound measurement is an indirect measure of gastric emptying rate. Participants' metabolic satiety for the test meals will also be assessed at regular intervals throughout the testing session. Each testing session will take approximately four hours in duration and the testing sessions will take place at least five days apart.
- Conditions
- Metabolic Diseases
- Being tested
- Fine emulsion, Coarse emulsion, Control
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine emulsionOther
Emulsion is made up of distilled water, olive oil and emulsifier. Emulsion will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment.
Coarse emulsionOther
Emulsion is made up of distilled water, olive oil and emulsifier. Emulsion will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment.
ControlOther
Beverage is made up of distilled water and olive oil. Beverage will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment.
| Study group | Role | What they receive |
|---|---|---|
| Fine emulsion | Experimental | Emulsion with small lipid droplet size served together with white bread Receives: Other: Fine emulsion |
| Coarse emulsion | Experimental | Emulsion with large lipid droplet size served together with white bread Receives: Other: Coarse emulsion |
| Control | Experimental | Non-emulsified oil and water served together with white bread Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic response
Blood glucose response to the test meal measured over 4 hours
Measured: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Secondary outcomes (5)
Insulinemic response
Plasma insulin response to the test meal measured over 4 hours
Measured: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Triglycerides response
Plasma triglycerides response to the test meal measured over 4 hours
Measured: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Non-esterified fatty acid (NEFA) response
Plasma NEFA response to the test meal measured over 4 hours
Measured: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Gastric emptying
Gastric antrum dimension measured over 2 hours
Measured: 2 hours post-prandial (0, 15, 45, 90 and 120 min)
Post-test-meal subjective appetite rating
Appetite ratings will be collected after test meal consumption using a previously validated visual analog scales
Measured: 4 hours (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startJul 2015
- 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 Metabolic DiseasesStudies 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
- None (open label)
- Enrolment
- 20 participants (estimated)
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
- NCT02789683
- Sponsor's protocol ID
- 2015/00509
- Other IDs
- 2015
- Status last verified
- Nov 2016
- First submitted
- 19 Apr 2016
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Emulsification and Lipid Droplet Size on Postprandial Metabolic Responses
- ClinicalTrials.gov ID
- NCT02789683
- Acronym / sponsor ID
- 2015/00509
- Conditions
- Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- Jul 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Jun 2016 (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 aim of this study is to compare the effects of emulsification and lipid droplet size on gastric emptying rate, and to determine if the change in gastric emptying rate can in turn influence postprandial glycemic, insulinemic and lipidemic responses.
Detailed description
This study will be conducted using a randomized, crossover design with three dietary phases: 1) fine emulsion beverage (small lipid droplet size), 2) coarse emulsion beverage (large lipid droplet size) and 3) non-emulsified oil and water. All treatments will be consumed together with bread. All participants will be randomly allocated to the three test meals. Fifteen to twenty participants aged between 21 and 50 years will be recruited from the general public in Singapore.
During the testing sessions, participants' glycemic, insulinemic, lipidemic responses and gastric emptying to the test meals will be measured. Gastric antral distention ultrasound measurement is an indirect measure of gastric emptying rate. Participants' metabolic satiety for the test meals will also be assessed at regular intervals throughout the testing session. Each testing session will take approximately four hours in duration and the testing sessions will take place at least five days apart.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fine emulsion | Experimental | Other: Fine emulsionEmulsion with small lipid droplet size served together with white bread |
| Coarse emulsion | Experimental | Other: Coarse emulsionEmulsion with large lipid droplet size served together with white bread |
| Control | Experimental | Other: ControlNon-emulsified oil and water served together with white bread |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Chinese male subjects aged between 21 and 50 years
- Body mass index between 20.0 to 24.9 kg/m2
- Normal blood pressure (<140/90 mmHg)
- Fasting blood glucose <6.0 mmol/L
Key exclusion criteria (7 listed)
- People with major chronic disease such as heart disease, cancer or diabetes mellitus
- People with family history of diabetes or familial cholesterolaemic
- People with history of liver or renal problems
- People who have intolerances or allergies to test products
- Individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution
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 |
|---|---|---|
| Fine emulsionEmulsion is made up of distilled water, olive oil and emulsifier. Emulsion will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment. | Other | Fine emulsion |
| Coarse emulsionEmulsion is made up of distilled water, olive oil and emulsifier. Emulsion will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment. | Other | Coarse emulsion |
| ControlBeverage is made up of distilled water and olive oil. Beverage will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment. | Other | Control |
Primary outcome
Glycemic response
Time frame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Blood glucose response to the test meal measured over 4 hours
5 secondary outcomes
Insulinemic response
Time frame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Triglycerides response
Time frame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Non-esterified fatty acid (NEFA) response
Time frame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
Gastric emptying
Time frame: 2 hours post-prandial (0, 15, 45, 90 and 120 min)
Post-test-meal subjective appetite rating
Time frame: 4 hours (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)
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 7 Nov 2016.
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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 Fine emulsion and Coarse emulsion in people with Metabolic Diseases, 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 4 inclusion and 7 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 7 Nov 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?
Glycemic response (time frame: 4 hours post-prandial (0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min)). 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 7 Nov 2016.