Effects of Canola Oil on Vascular and Metabolic Parameters in Individuals With Metabolic Syndrome

Study Overview
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Brief Summary
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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, hypertension, elevated fasting blood glucose) accompanied by low grade chronic inflammation, hepatic steatosis (fatty liver) and reduced vascular function. This study will investigate the effect of a 12 week intervention with canola oil versus the typical fat mixture in the Western diet on blood lipids, blood vessel function and MetS parameters. CVD risk will be assessed based on the profile of lipids and other factors in the blood as well using specialized equipment for non-invasive monitoring of blood vessel function.

Detailed Description
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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 to cardiovascular disease (CVD) and other chronic diseases. While it has been shown that modification of dietary fat intake can play an important role in prevention and management of CVD there is an absence of dietary intervention studies focusing on dietary oils and early stage modification of MetS components, particularly those affecting progression to CVD. The composition of canola oil is considered healthy. However, there is a lack of scientifically sound clinical studies directly comparing canola oil with other fats in the diet. Given that much of the evidence for current dietary recommendations for type and amounts of fatty acids is based on heart disease, the proposed research will contribute to the knowledge base for dietary fat recommendations for individuals with MetS. Specifically, this study will investigate the effect of a 12 week intervention with canola oil versus the typical fat mixture in the Western diet on blood lipids, blood vessel function and MetS parameters. CVD risk will be assessed based on the profile of lipids and other factors in the blood as well using specialized equipment for non-invasive monitoring of blood vessel function.

Official Title
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Effects of Canola Oil on Vascular and Metabolic Parameters in Individuals With Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: Canola Oil 25 g/d
* Other: Non-Canola Oil Mixture 25 g/d


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canola Oil 25 g/d<br>Participants randomized to this arm will be provided with food items including entrées, side dishes, salad dressing, baked goods, and desserts prepared with traditional canola oil to incorporate into their usual eating pattern. They will consume one or two food items per day containing a total of 25 g/d of Canola oil. | Other: Canola Oil 25 g/d<br>* Daily consumption of food items containing traditional canola oil (25 g/d) for 12 weeks.<br>|
| Active Comparator: Non-Canola Oil Mixture 25 g/d<br>Participants randomized to this arm will be provided with food items including entrées, side dishes, salad dressing, baked goods, and desserts prepared with an oil mixture representing the typical Western diet to incorporate into their usual eating pattern. They will consume one or two food items per day containing a total of 25 g/d of the non-canola oil mixture. | Other: Non-Canola Oil Mixture 25 g/d<br>* Daily consumption of food items containing Non-Canola Oil Mixture (25 g/d) representing the typical Western diet for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fasting Serum LDL-cholesterol | Fasting blood sample will be taken at Baseline (Day 1), Week 6 (Day 56) amd Week 12 (Day 84) for purpose of analysis of Serum LDL-Cholesterol. | Baseline, Week 6 and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Vessel Function | Blood vessel function will assessed and compared at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) via pulse wave analysis and pulse ave velocity. | Baseline, Week 6 and Week 12 | 
| Change in Total Cholesterol | A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of serum total cholesterol | Baseline, Week 6, and Week 12 | 
| Change in Advanced Glycation Endproducts (AGEs) | Advanced Glycation Endproducts (AGEs) will be obtained and compared at Baseline (Day 1), Week 6 (Day 56), and Week 12 (Day 84) using the AGE Reader. | Baseline, Week 6, and Week 12 | 
| Change in Biomarkers of Vascular Function | A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56), and Week 12 (Day 84) for the assessment and comparison of biomarkers of vascular function, inflammation, oxidative stress, and immune function. | Baseline, Week 6 and Week 12 | 
| Change in Total Body Fat Composition | Participants will undergo a body composition scan using a GE Lunar Dual Energy X-Ray Absorptiometry scanner to determine the percentage of total body fat, abdominal fat, and percentage of lean muscle mass at Baseline (Day 1) and Week 12 (Day 84). | Baseline and Week 12 | 
| Change in Fatty Liver | Fatty liver will be assessed through serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST). | Baseline and Week 12 | 
| Change in Anthropometrics | Weight, body mass index (BMI), and waist circumference and will be obtained and compared at with Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84). | Baseline, Week 6 and Week 12 | 
| Change in HDL-Cholesterol | A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of HDL-cholesterol. | Baseline, Week 6, and Week 12 | 
| Change in Triglycerides | A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of serum triglycerides. | Baseline, Week 6, and Week 12 | 
| Change in Fasting Blood Glucose | A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of glucose. | Baseline, Week 6 and Week 12 | 
| Change in Fasting Insulin | A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of insulin (and calculation of insulin sensitivity using HOMA-IR, QUICKI). | Baseline, Week 6 and Week 12 | 
| Change in Glycated Hemoglobin (HbA1c) | A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of glycated hemoglobin (HbA1c). | Baseline, Week 6 and Week 12 | 
| Change in fasting C-reactive protein | A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of C-reactive protein. | Baseline, Week 6 and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Canola Oil, Metabolic Syndrome, Serum LDL cholesterol