Canola Oil, Fibre and DHA Enhanced Clinical Trial

N/ACompletedNCT02091583

University of Manitoba30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Metabolic Syndrome

Interventions

Butter, sunflower and safflower oilDIETARY_SUPPLEMENT

High Oleic Canola Oil and DHA (HOCO-DHA)DIETARY_SUPPLEMENT

Barley beta-glucanDIETARY_SUPPLEMENT

HOCO-DHA and Barley beta-glucan

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Change in 10-year Framingham CVD risk score

Change in 10-year Framingham CVD risk will be assessed using the multivariable Framingham risk equation.

Time frame: 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 Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Measurements will be done at the beginning and end of each of the four 4-week treatment phases over a period of seven months

Data from ClinicalTrials.gov

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