Canola Oil, Fibre and DHA Enhanced Clinical Trial

Study Overview
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Brief Summary
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The purpose of this study is to examine the effects of consumption of a novel food supplement consisting of Canola Oil, Fibre and DHA, containing the most effective food bioactives, including n-3 fatty acid enriched dietary oil high in monounsaturated fatty acids (MUFAs) and soluble dietary fibre, aiming at the management of heart disease risk factors in people with metabolic syndrome and to test its efficacy and safety in humans.

Detailed Description
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The proposed study is a randomized, single-blind, crossover trial, it will be conducted at the Richardson Centre for Functional Food and Nutraceuticals (RCFFN), University of Manitoba. The study design will consist of 4 phases with 30 days per phase, each phase will be separated by 4-week washout periods. Participants will consume a recommended weight-maintaining diet (35% energy from fat, 50% carbohydrate, 15% protein) supplemented with the following novel Muffin and cookies: (a) control food containing butter, sunflower and safflower oil comprised largely of saturated fat with substantial levels of n-6 linoleic acid, and refined wheat flour common to current North American intakes, (b) food containing high oleic canola oil and docosahexaenoic acid (HOCO-DHA) and refined wheat flour, (c) food containing high molecular weight barley B-glucan and a combination of sunflower, safflower oil and butter, (d) food containing combination of HOCO-DHA and high molecular weight barley β-glucan. Treatments will be isocalorically incorporated into muffin and cookies consumed in equal parts at breakfast and supper.

Official Title
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Developing and Evaluating a Novel Food Supplement, Consisting of Canola Oil, Fibre and DHA, Aiming at the Management of CVD Risk in a Population With Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Butter, sunflower and safflower oil
* Dietary Supplement: High Oleic Canola Oil and DHA (HOCO-DHA)
* Dietary Supplement: Barley beta-glucan
* Dietary Supplement: HOCO-DHA and Barley beta-glucan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI≥25 Kg/m2 Waist circumference ≥94 cm (males) or ≥80 cm (females) Meet at least two of the following: Triglycerides ≥1.7 mmol/L High density lipoprotein (HDL) cholesterol <1 mmol/L (males) or <1.3 mmol/L (females) Low density lipoprotein (LDL) cholesterol ≥2.7 mmol/L Fasting glucose ≥5.6 mmol/L Exclusion Criteria: Consuming lipid lowering medications Consuming nutritional supplements Disease or disorder that could interfere with absorption Smokers Hypertension ≥150 mmHg (systolic) and/or ≥100 mmHg (diastolic) Planning to become pregnant Consume >1 alcoholic drink/day Medication within a month prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Butter, sunflower and safflower oil<br>The oil (50g/day) is given in muffin and cookies made with refined wheat flour (3 g/day)daily for 4 weeks. | Dietary Supplement: Butter, sunflower and safflower oil<br> <br> |
| Active Comparator: High Oleic Canola Oil and DHA (HOCO-DHA)<br>The oil (50g/day) is given in muffin and cookies made with refined wheat flour (3 g/day) daily for 4 weeks. | Dietary Supplement: High Oleic Canola Oil and DHA (HOCO-DHA)<br> <br> |
| Active Comparator: Barley Beta-glucan<br>The Barley beta-glucan (3 g/day) is given in muffin and cookies made with a combination of butter, sunflower and safflower oil (50 g/day) daily for 4 weeks. | Dietary Supplement: Barley beta-glucan<br> <br> |
| Active Comparator: HOCO-DHA and Barley beta-glucan<br>The oil and beta-glucan (50g and 3g/day, respectively) is given in muffin and cookies daily for 4 weeks. | Dietary Supplement: HOCO-DHA and Barley beta-glucan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 10-year Framingham CVD risk score | Change in 10-year Framingham CVD risk will be assessed using the multivariable Framingham risk equation. | The 10-year Framingham CVD risk score will be calculated for each participant at the end of each four 4-week treatment phases over a period of seven months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood lipid profile (TC, TG, LDL-C, HDL-C) | Lipid profile will be determined using the automated enzymatic methods. Subfractions and particle size of LDL-C and HDL-C will be determined by LipoprintR system. | Blood samples will be collected at the start and end of each of the four 4-week treatment phases over a period of seven months | 
| Change in inflammatory markers | Determination of inflammatory markers and cytokines will be measured by commercially available ELISA kits. | Blood samples will be collected at the start and end of each of the four 4-week treatment phases over a period of seven months | 
| Cholesterol synthesis rate | Participants will be asked to consume deuterium oxide (D2O) at the end of each phase. In addition, on day 29 a fasting baseline blood sample is taken prior to administration of an oral dose of D2O as tracer to measure fractional cholesterol synthesis. Fasting blood samples will be obtained 24 h following the tracer dose on day 30. | Fasting blood samples will be collected during the last 2 days of the four 4-week treatment phases over a period of seven months | 
| Change in body composition | Changes in body composition will be assessed using dual-energy X-ray absorptiometry (DXA) scans. In addition, body weight, waist and hip circumferences will be measured. | Measurements will be done at the beginning and end of each of the four 4-week treatment phases over a period of seven months | 
| Blood Pressure | Blood pressure data (change in both systolic and diastolic) was taken 4 times at 2-minutes intervals. The last 3 measurements will be averaged. | Measurements will be done at the beginning and end of each of the four 4-week treatment phases over a period of seven months | 
| Fasting plasma insulin concentration | Insulin homeostasis modelling assessment will be utilised as an estimate for % β-cell function and insulin resistance. | Blood samples will be collected at the start and end of each of the four 4-week treatment phases over a period of seven months | 
| Plasma and RBC fatty acid analysis | Plasma and RBC total lipids will be extracted using the Folch method involving chloroform-methanol (2:1, v/v) containing 0·01% BHT and heptadecanoic acid as an internal standard. Extracted fatty acids will be methylated with methanolic HCl. Fatty acid methyl esters will be separated on a Supelcowax 10 column using a gas chromatograph equipped with a flame ionisation detector . | Blood samples will be collected at the start and end of each of the four 4-week treatment phases over a period of seven months | 
| Microbiome analysis | Bacterial DNA from the fecal samples will be extracted using ZR Fecal DNA MiniPrepTM kit and DNA concentration along with quality will be determined using a NanoDrop 2000c.The gut microbial composition will be analysed by next generation Illumina based sequencing | Fecal samples will be collected at the start and end of each of the four 4-week treatment phases over a period of seven months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic syndrome, Cardiovascular disease, High Oleic Canola Oil, DHA, β-glucan, Barley, Cholesterol, Lipoproteins, Lipids, Inflammation, Glucose, Insulin, Satiety, Body composition, Blood pressure