Optimizing Dietary Fatty Acids to Lower Metabolic Risk Factors Among Canadians
Primary Purpose
Postprandial Lipaemia
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
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
In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter
In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter
Sponsored by
About this trial
This is an interventional health services research trial for Postprandial Lipaemia focused on measuring Postprandial lipids, test meal, fatty acids
Eligibility Criteria
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
Sites / Locations
- Child & Family Research Institute, BC Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
In this study subjects will consume test meals containing vegetable oils (soy) and butter
In this study subjects will consume test meals containing vegetable oils (flaxseed) and butter
In this study subjects will consume test meals containing vegetable oils (high oleic safflower) and butter
In this study subjects will consume test meals containing vegetable oils (canola) and butter
Outcomes
Primary Outcome Measures
Outcome Plasma triglyceride and fatty acids after eating an oil or fat
Secondary Outcome Measures
Full Information
NCT ID
NCT01067911
First Posted
February 10, 2010
Last Updated
May 31, 2016
Sponsor
University of British Columbia
Collaborators
Flax Council of Canada
1. Study Identification
Unique Protocol Identification Number
NCT01067911
Brief Title
Optimizing Dietary Fatty Acids to Lower Metabolic Risk Factors Among Canadians
Official Title
Optimizing Dietary Fatty Acids to Lower Metabolic Risk Factors Among Canadians
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Not enough enrollment, study needs to be revised
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Flax Council of Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Lipaemia
Keywords
Postprandial lipids, test meal, fatty acids
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
In this study subjects will consume test meals containing vegetable oils (soy) and butter
Arm Title
2
Arm Type
Active Comparator
Arm Description
In this study subjects will consume test meals containing vegetable oils (flaxseed) and butter
Arm Title
3
Arm Type
Active Comparator
Arm Description
In this study subjects will consume test meals containing vegetable oils (high oleic safflower) and butter
Arm Title
4
Arm Type
Active Comparator
Arm Description
In this study subjects will consume test meals containing vegetable oils (canola) and butter
Intervention Type
Dietary Supplement
Intervention Name(s)
Butter and Vegetable oils from soy, flaxseed, high oleic safflower and canola
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Outcome Plasma triglyceride and fatty acids after eating an oil or fat
Time Frame
8 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila M. Innis, Dr.
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child & Family Research Institute, BC Children's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
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Optimizing Dietary Fatty Acids to Lower Metabolic Risk Factors Among Canadians
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