- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01067911
Optimizing Dietary Fatty Acids to Lower Metabolic Risk Factors Among Canadians
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada
- Child & Family Research Institute, BC Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
In this study subjects will consume test meals containing vegetable oils (soy) and butter
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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.
|
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Active Comparator: 2
In this study subjects will consume test meals containing vegetable oils (flaxseed) and butter
|
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.
|
|
Active Comparator: 3
In this study subjects will consume test meals containing vegetable oils (high oleic safflower) and butter
|
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.
|
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Active Comparator: 4
In this study subjects will consume test meals containing vegetable oils (canola) and butter
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Outcome Plasma triglyceride and fatty acids after eating an oil or fat
Time Frame: 8 hours
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8 hours
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H09-00188
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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