Study Stopped
Not enough enrollment, study needs to be revised
Optimizing Dietary Fatty Acids to Lower Metabolic Risk Factors Among Canadians
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 10, 2010
CompletedFirst Posted
Study publicly available on registry
February 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJune 1, 2016
May 1, 2016
3.5 years
February 10, 2010
May 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Outcome Plasma triglyceride and fatty acids after eating an oil or fat
8 hours
Study Arms (4)
1
ACTIVE COMPARATORIn this study subjects will consume test meals containing vegetable oils (soy) and butter
2
ACTIVE COMPARATORIn this study subjects will consume test meals containing vegetable oils (flaxseed) and butter
3
ACTIVE COMPARATORIn this study subjects will consume test meals containing vegetable oils (high oleic safflower) and butter
4
ACTIVE COMPARATORIn this study subjects will consume test meals containing vegetable oils (canola) and butter
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Flax Council of Canadacollaborator
Study Sites (1)
Child & Family Research Institute, BC Children's Hospital
Vancouver, British Columbia, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheila M. Innis, Dr.
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2010
First Posted
February 12, 2010
Study Start
July 1, 2009
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
June 1, 2016
Record last verified: 2016-05