Canola Oil, Fibre and DHA Enhanced Clinical Trial

University of Manitoba

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Butter, sunflower and safflower oil; Dietary Supplement: HOCO-DHA and Barley beta-glucan; Dietary Supplement: Barley beta-glucan; Dietary Supplement: High Oleic Canola Oil and DHA (HOCO-DHA)

Study type: Interventional

Funder types: Other

Identifiers

NCT02091583

B2014:029

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 4 patient groups, including a placebo group

Butter, sunflower and safflower oil

Placebo Comparator group

Description:

The oil (50g/day) is given in muffin and cookies made with refined wheat flour (3 g/day)daily for 4 weeks.

Treatment:

Dietary Supplement: Butter, sunflower and safflower oil

High Oleic Canola Oil and DHA (HOCO-DHA)

Active Comparator group

Description:

The oil (50g/day) is given in muffin and cookies made with refined wheat flour (3 g/day) daily for 4 weeks.

Treatment:

Dietary Supplement: High Oleic Canola Oil and DHA (HOCO-DHA)

Barley Beta-glucan

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Barley beta-glucan

HOCO-DHA and Barley beta-glucan

Active Comparator group

Description:

The oil and beta-glucan (50g and 3g/day, respectively) is given in muffin and cookies daily for 4 weeks.

Treatment:

Dietary Supplement: HOCO-DHA and Barley beta-glucan