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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-03-31

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.

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Canola Oil 25 g/d

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.

Group Type EXPERIMENTAL

Canola Oil 25 g/d

Intervention Type OTHER

Daily consumption of food items containing traditional canola oil (25 g/d) for 12 weeks.

Non-Canola Oil Mixture 25 g/d

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.

Group Type ACTIVE_COMPARATOR

Non-Canola Oil Mixture 25 g/d

Intervention Type OTHER

Daily consumption of food items containing Non-Canola Oil Mixture (25 g/d) representing the typical Western diet for 12 weeks.

Interventions

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Canola Oil 25 g/d

Daily consumption of food items containing traditional canola oil (25 g/d) for 12 weeks.

Intervention Type OTHER

Non-Canola Oil Mixture 25 g/d

Daily consumption of food items containing Non-Canola Oil Mixture (25 g/d) representing the typical Western diet for 12 weeks.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No