Postprandial LipaemiaNCT01067911
Optimizing Dietary Fatty Acids to Lower Metabolic Risk Factors Among Canadians
A study testing Butter and Vegetable oils from soy, flaxseed, high oleic safflower and canola and In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter in people with Postprandial Lipaemia, run by University of British Columbia at 1 site in Canada.
Trial summary
Scientists believe that what happens to dietary fats after they are eaten, especially how they cleared from the blood, affects risks of heart disease and diabetes is more important than measuring blood fats after an overnight fast. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Postprandial Lipaemia
- What is being tested?
- Butter and Vegetable oils from soy, flaxseed, high oleic safflower and canola and In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Jan 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Non-smoking, with BMI > 19 < 28 kg/m2
- Waist circumference < 102 cm (40 in) for men and < 88 cm (35 in) for women
- No known chronic disease such as diabetes, heart or thyroid disease or disorder of fat metabolism
- Not taking OTC or prescription medications, not following a vegan or vegetarian diet, not taking fish oil
- Willing to avoid some high fat foods and alcohol for two days, then eat a standardized meal with collection of blood samples over the following 8 hours
Who cannot join
- No elite athletes or those engaged in vigorous physical activity
- Smokers or those with BMI > 28 or <19
- Waist circumference > 102 cm for men and 88 cm for women
- Known chronic disease such as diabetes or disease involving fat metabolism, the heart or thyroid will be excluded from the study
- Subjects who take any routine prescribed or over-the-counter medications, fatty acids, antioxidant or fish oil, those following a vegan or vegetarian diet, and those who are not willing to abstain from alcoholic beverages and high fat foods for 2 days prior to the test meal and not willing to eat a standardized meal and provide blood samples over the following 8 hours
Trial locations and contacts
1 site in 1 country.
Canada1 site
Child & Family Research Institute, BC Children's Hospital
Vancouver, British Columbia
About this study
Scientists believe that what happens to dietary fats after they are eaten, especially how they cleared from the blood, affects risks of heart disease and diabetes is more important than measuring blood fats after an overnight fast. Little is known about what happens in the 6-8 hours after eating common oils available in Canada such as soybean, canola, olive, sunflower or flax oils. Vegetable oils have different types of fatty acids. This study will gather information on what happens to these fatty acids after they are eaten in a meal. The purpose of this research is to show that clearance of fat from the blood varies with the type of vegetable oil in a meal.
Read the detailed description
The purpose of the present studies is to show that the types of vegetable oil in a meal alter postprandial lipaemia and the transport of n-3 fatty acids. The hypothesis is that a meal which is low in 18:2n-6 and high in the monounsaturated fatty acid 18:1n-9 and 18:3n-3 will result in lower postprandial lipaemia and higher long chain n-3 fatty acids in the unesterified fatty acids when compared to the same meal either high 18:2n-6 and low 18:3n-3. The specific objectives are to determine the magnitude and duration of the increase in plasma TG and the fatty acid composition of chylomicron, LDL and HDL and unesterified fatty acids over 8 hours following the intake of a standard meal with approx 35- 40% energy from fat containing different vegetable oils. The objectives are to show that amount and balance of 18:1n-9, 18:2n-6 and 18:3n-3 in the meal is an important determinant of the extent and duration of postprandial lipaemia, and the appearance of 18:3n-3 and its metabolites in TG and unesterified fatty acids. We will use test meals prepared with different amounts of common fats and oils to provide varying 18:2n-6, 18:3n-3 and 18:1n-9. All the meals will provide less than 10% energy as saturated fatty acids with approx 35% total energy from fat. We also aim to identify the most useful single time point to show differences in plasma post-prandial lipaemia and fatty acids for use in studies in which sequential, repeated blood sampling in the post meal phase is not practical.
Subject characteristics and baseline parameters will be presented using descriptive statistics. Differences in the TG response among subjects and different fats and oils will be assessed using ANOVA, with the use of ANCOVA. Differences in fatty acids at the same time point among the diets will be compared using ANOVA. Prior to analysis, all data will be checked and for those displaying non normal distributions. A P-value <0.05 will be considered statistically significant.
- Conditions
- Postprandial Lipaemia
- Being tested
- Butter and Vegetable oils from soy, flaxseed, high oleic safflower and canola, In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter
- Keywords
- Postprandial lipids, test meal, fatty acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butter and Vegetable oils from soy, flaxseed, high oleic safflower and canolaDietary supplement
Test meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal.
In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butterDietary supplement
Test meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal.
In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butterDietary supplement
Test meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal.
In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butterDietary supplement
Test meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | In this study subjects will consume test meals containing vegetable oils (soy) and butter Receives: Dietary Supplement: Butter and Vegetable oils from soy, flaxseed, high oleic safflower and canola |
| 2 | Active comparator | In this study subjects will consume test meals containing vegetable oils (flaxseed) and butter Receives: Dietary Supplement: In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter |
| 3 | Active comparator | In this study subjects will consume test meals containing vegetable oils (high oleic safflower) and butter Receives: Dietary Supplement: In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter |
| 4 | Active comparator | In this study subjects will consume test meals containing vegetable oils (canola) and butter Receives: Dietary Supplement: In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Plasma triglyceride and fatty acids after eating an oil or fat
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startJul 2009
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Not enough enrollment, study needs to be revised
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial LipaemiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Flax Council of Canada
- Responsible party
- Sponsor
- Investigators
- Sheila M. Innis, Dr., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067911
- Sponsor's protocol ID
- H09-00188
- Status last verified
- May 2016
- First submitted
- 10 Feb 2010
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Dietary Fatty Acids to Lower Metabolic Risk Factors Among Canadians
- ClinicalTrials.gov ID
- NCT01067911
- Acronym / sponsor ID
- H09-00188
- Conditions
- Postprandial Lipaemia
- Keywords
- Postprandial lipids, test meal, fatty acids
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough enrollment, study needs to be revised
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Flax Council of Canada
- Study start
- Jul 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Feb 2010 (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.
Scientists believe that what happens to dietary fats after they are eaten, especially how they cleared from the blood, affects risks of heart disease and diabetes is more important than measuring blood fats after an overnight fast. Little is known about what happens in the 6-8 hours after eating common oils available in Canada such as soybean, canola, olive, sunflower or flax oils. Vegetable oils have different types of fatty acids. This study will gather information on what happens to these fatty acids after they are eaten in a meal. The purpose of this research is to show that clearance of fat from the blood varies with the type of vegetable oil in a meal.
Detailed description
The purpose of the present studies is to show that the types of vegetable oil in a meal alter postprandial lipaemia and the transport of n-3 fatty acids. The hypothesis is that a meal which is low in 18:2n-6 and high in the monounsaturated fatty acid 18:1n-9 and 18:3n-3 will result in lower postprandial lipaemia and higher long chain n-3 fatty acids in the unesterified fatty acids when compared to the same meal either high 18:2n-6 and low 18:3n-3. The specific objectives are to determine the magnitude and duration of the increase in plasma TG and the fatty acid composition of chylomicron, LDL and HDL and unesterified fatty acids over 8 hours following the intake of a standard meal with approx 35- 40% energy from fat containing different vegetable oils. The objectives are to show that amount and balance of 18:1n-9, 18:2n-6 and 18:3n-3 in the meal is an important determinant of the extent and duration of postprandial lipaemia, and the appearance of 18:3n-3 and its metabolites in TG and unesterified fatty acids. We will use test meals prepared with different amounts of common fats and oils to provide varying 18:2n-6, 18:3n-3 and 18:1n-9. All the meals will provide less than 10% energy as saturated fatty acids with approx 35% total energy from fat. We also aim to identify the most useful single time point to show differences in plasma post-prandial lipaemia and fatty acids for use in studies in which sequential, repeated blood sampling in the post meal phase is not practical.
Subject characteristics and baseline parameters will be presented using descriptive statistics. Differences in the TG response among subjects and different fats and oils will be assessed using ANOVA, with the use of ANCOVA. Differences in fatty acids at the same time point among the diets will be compared using ANOVA. Prior to analysis, all data will be checked and for those displaying non normal distributions. A P-value <0.05 will be considered statistically significant.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Butter and Vegetable oils from soy, flaxseed, high oleic safflower and canolaIn this study subjects will consume test meals containing vegetable oils (soy) and butter |
| 2 | Active comparator | Dietary Supplement: In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butterIn this study subjects will consume test meals containing vegetable oils (flaxseed) and butter |
| 3 | Active comparator | Dietary Supplement: In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butterIn this study subjects will consume test meals containing vegetable oils (high oleic safflower) and butter |
| 4 | Active comparator | Dietary Supplement: In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butterIn this study subjects will consume test meals containing vegetable oils (canola) and butter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Non-smoking, with BMI > 19 < 28 kg/m2
- Waist circumference < 102 cm (40 in) for men and < 88 cm (35 in) for women
- No known chronic disease such as diabetes, heart or thyroid disease or disorder of fat metabolism
- Not taking OTC or prescription medications, not following a vegan or vegetarian diet, not taking fish oil
- Willing to avoid some high fat foods and alcohol for two days, then eat a standardized meal with collection of blood samples over the following 8 hours
Key exclusion criteria (5 listed)
- No elite athletes or those engaged in vigorous physical activity
- Smokers or those with BMI > 28 or <19
- Waist circumference > 102 cm for men and 88 cm for women
- Known chronic disease such as diabetes or disease involving fat metabolism, the heart or thyroid will be excluded from the study
- Subjects who take any routine prescribed or over-the-counter medications, fatty acids, antioxidant or fish oil, those following a vegan or vegetarian diet, and those who are not willing to abstain from alcoholic beverages and high fat foods for 2 days prior to the test meal and not willing to eat a standardized meal and provide blood samples over the following 8 hours
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 |
|---|---|---|
| Butter and Vegetable oils from soy, flaxseed, high oleic safflower and canolaTest meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal. | Dietary supplement | 1 |
| In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butterTest meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal. | Dietary supplement | 2 |
| In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butterTest meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal. | Dietary supplement | 3 |
| In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butterTest meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal. | Dietary supplement | 4 |
Primary outcome
Outcome Plasma triglyceride and fatty acids after eating an oil or fat
Time frame: 8 hours
Results and safety
The study was stopped early (reason given: Not enough enrollment, study needs to be revised). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 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.
Sheila M. Innis, Dr. principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butter and Vegetable oils from soy, flaxseed, high oleic safflower and canola and In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter in people with Postprandial Lipaemia, run by University of British Columbia at 1 site in Canada.
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 5 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: stopped early, as of the sponsor's last update on 1 Jun 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 Canada. 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 was stopped early (reason given: Not enough enrollment, study needs to be revised). Results are not available in the source record.
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?
Outcome Plasma triglyceride and fatty acids after eating an oil or fat (time frame: 8 hours). 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 1 Jun 2016.