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| Name | Class |
|---|---|
| Alberta Innovates Bio Solutions | OTHER |
| Alberta Canola Producers Commission | UNKNOWN |
| Canola Council of Canada | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canola Oil 25 g/d | Experimental | 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. |
|
| Non-Canola Oil Mixture 25 g/d | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canola Oil 25 g/d | Other | Daily consumption of food items containing traditional canola oil (25 g/d) for 12 weeks. |
|
| 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 |
| 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 |
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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
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Carla Taylor, PhD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Boniface General Hospital - I.H. Asper Clinical Research Institute | Winnipeg | Manitoba | R2H 2A6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17167477 | Background | Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488. | |
| 19211817 | Result | Jakobsen MU, O'Reilly EJ, Heitmann BL, Pereira MA, Balter K, Fraser GE, Goldbourt U, Hallmans G, Knekt P, Liu S, Pietinen P, Spiegelman D, Stevens J, Virtamo J, Willett WC, Ascherio A. Major types of dietary fat and risk of coronary heart disease: a pooled analysis of 11 cohort studies. Am J Clin Nutr. 2009 May;89(5):1425-32. doi: 10.3945/ajcn.2008.27124. Epub 2009 Feb 11. |
| Label | URL |
|---|---|
| Canadian Centre for Agri-Food Research in Health and Medicine | View source |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000074262 | Rapeseed Oil |
| ID | Term |
|---|---|
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 |
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| Non-Canola Oil Mixture 25 g/d | Other | Daily consumption of food items containing Non-Canola Oil Mixture (25 g/d) representing the typical Western diet for 12 weeks. |
|
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 |
| 33380172 | Derived | Pauls SD, Du Y, Clair L, Winter T, Aukema HM, Taylor CG, Zahradka P. Impact of Age, Menopause, and Obesity on Oxylipins Linked to Vascular Health. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):883-897. doi: 10.1161/ATVBAHA.120.315133. Epub 2020 Dec 31. |
| D009750 |
| Nutritional and Metabolic Diseases |
| Biological Products |
| D045424 | Complex Mixtures |