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

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: Non-Canola Oil Mixture 25 g/d; Other: Canola Oil 25 g/d

• Registration Number: NCT01890330
• Lead Sponsor: University of Manitoba

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, 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

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 Timeline

• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-26
• Study Start: 2013-07
• Study First Posted: 2013-07-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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;

6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Canola Oil Mixture 25 g/d	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.
Canola Oil 25 g/d	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.

Primary Outcome Measures

Name	Time	Method
Change in Fasting Serum LDL-cholesterol	Baseline, Week 6 and Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Change in Advanced Glycation Endproducts (AGEs)	Baseline, Week 6, and Week 12	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.
Change in HDL-Cholesterol	Baseline, Week 6, and Week 12	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.
Change in fasting C-reactive protein	Baseline, Week 6 and Week 12	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.
Change in Fatty Liver	Baseline and Week 12	Fatty liver will be assessed through serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Change in Fasting Blood Glucose	Baseline, Week 6 and Week 12	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.
Change in Biomarkers of Vascular Function	Baseline, Week 6 and Week 12	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.
Change in Anthropometrics	Baseline, Week 6 and Week 12	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).
Change in Glycated Hemoglobin (HbA1c)	Baseline, Week 6 and Week 12	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).
Change in Blood Vessel Function	Baseline, Week 6 and Week 12	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.
Change in Total Cholesterol	Baseline, Week 6, and Week 12	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
Change in Total Body Fat Composition	Baseline and Week 12	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).
Change in Triglycerides	Baseline, Week 6, and Week 12	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.
Change in Fasting Insulin	Baseline, Week 6 and Week 12	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).

Trial Locations

Locations (1)

St. Boniface General Hospital - I.H. Asper Clinical Research Institute; 🇨🇦 Winnipeg, Manitoba, Canada