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

University of Manitoba80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male, or non-pregnant, non-lactating females, aged 20 - 75 years; 2. LDL-Cholesterol \>2.5 mmol/L and \<5.0 mmol/L 3. 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. 4. Able to read, write and communicate orally in English; 5. Willing to maintain a stable level of activity during participation in the study; 6. 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; 7. Willing to comply with protocol requirements and procedures; 8. Willing to provide written informed consent. Exclusion Criteria: 1. Use of prescribed medications for lowering or managing blood lipids (hyperlipidemia), blood glucose (hyper/hypoglycemia), blood pressure (hypertension) or body weight; 2. 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; 3. Participating in or adhering to a weight loss diet or physical activity program designed to facilitate weight loss. 4. Adhering to a physician or dietitian directed lifestyle or dietary modification program for the purpose of lowering hypercholesterolemia; 5. 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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 6 and Week 12

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: Baseline and Week 12

Change in Fatty Liver

Fatty liver will be assessed through serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: Baseline, Week 6 and Week 12

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes