Status:
COMPLETED
Effects of Canola Oil on Vascular and Metabolic Parameters in Individuals With Metabolic Syndrome
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Alberta Innovates Bio Solutions
Alberta Canola Producers Commission
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
MetS is an early stage of CVD and is an appropriate target for dietary interventions. MetS is a clustering of risk factors (abdominal obesity, elevated serum triglycerides, low HDL-cholesterol, hypert...
Detailed Description
The current, worldwide obesity epidemic is significantly increasing the number of individuals with Metabolic Syndrome (MetS), an early stage combination of risk factors which predisposes individuals t...
Eligibility Criteria
Inclusion
- Male, or non-pregnant, non-lactating females, aged 20 - 75 years;
- LDL-Cholesterol \>2.5 mmol/L and \<5.0 mmol/L
- If the participant has 2 or more of the following characteristics of MetS
- Fasting blood glucose \>5.6 mmol/L and \<7.0 mmol/L;
- Blood pressure \>130/85 mm Hg and \<150/100;
- Triglycerides \>1.7 mmol/L and \<4.0 mmol/L;
- HDL-cholesterol \<1.0 mmol/L in males or \<1.3 mmol/L in females;
- Abdominal obesity as defined by a waist circumference of \>102 cm (40 inches) in males and \>88 cm (35 inches) in females of non-Asian ethnicity, and a waist circumference of \>94 cm (37 inches) in males and \>80 cm (32 inches) in females of Asian ethnicity.
- Able to read, write and communicate orally in English;
- Willing to maintain a stable level of activity during participation in the study;
- Willing to maintain dietary routine, refrain from consuming omega-3 supplements or omega-3 rich foods (\>0.3 grams ALA/serving or, \>0.1 grams of EPA and DHA; see handout with examples) and refrain from taking any over-the-counter medications or herbal supplements specified for weight loss, or the lowering of blood lipids, blood glucose or blood pressure from acceptance into the study until the final study visit;
- Willing to comply with protocol requirements and procedures;
- Willing to provide written informed consent.
Exclusion
- Use of prescribed medications for lowering or managing blood lipids (hyperlipidemia), blood glucose (hyper/hypoglycemia), blood pressure (hypertension) or body weight;
- Regular use of non-prescription products, over-the-counter medications, or herbal supplements designed to lower blood lipids, blood glucose, blood pressure or body weight, or omega-3 supplements or omega-3 rich foods, within the past 3 months;
- Participating in or adhering to a weight loss diet or physical activity program designed to facilitate weight loss.
- Adhering to a physician or dietitian directed lifestyle or dietary modification program for the purpose of lowering hypercholesterolemia;
- Medical history of liver disease, with the exception of fatty liver, or chronic renal disease;
- 5\. Any acute medical condition or surgical intervention within the past 3 months; 6. Conditions or medications which are likely to increase the risk to the participants or study personnel, or to reduce the ability of the participant to comply with the protocol, or affect the results; 7. History of gastrointestinal reactions or allergies to canola oil or to one or more ingredients in the study foods which significantly limits the number of study foods that can be consumed; and 8. Currently participating in or having participated in a food intervention study within the last 3 months.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01890330
Start Date
July 1 2013
End Date
March 1 2016
Last Update
September 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Boniface General Hospital - I.H. Asper Clinical Research Institute
Winnipeg, Manitoba, Canada, R2H 2A6