Clinical trial NCT02091583: Canola Oil, Fibre and DHA Enhanced Clinical Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome
Cardiovascular disease
High Oleic Canola Oil
DHA
β-glucan
Barley
Cholesterol
Lipoproteins
Lipids
Inflammation
Glucose
Insulin
Satiety
Body composition
Blood pressure
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Agriculture and Agri-Food Canada
First posted: 2014-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in 10-year Framingham CVD risk score
timeFrame: 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:
measure: Change in blood lipid profile (TC, TG, LDL-C, HDL-C)
timeFrame: 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
measure: Change in inflammatory markers
timeFrame: 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
measure: Cholesterol synthesis rate
timeFrame: Fasting blood samples will be collected during the last 2 days of the four 4-week treatment phases over a period of seven months
measure: Change in body composition
timeFrame: Measurements will be done at the beginning and end of each of the four 4-week treatment phases over a period of seven months
measure: Blood Pressure
timeFrame: Measurements will be done at the beginning and end of each of the four 4-week treatment phases over a period of seven months
measure: Fasting plasma insulin concentration
timeFrame: 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
measure: Plasma and RBC fatty acid analysis
timeFrame: 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
measure: Microbiome analysis
timeFrame: 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
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
affiliation: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
name: Peter JH Jones, PhD
role: STUDY_CHAIR
affiliation: Agriculture and Agri-Food Canada
name: Nancy Ames, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
name: Vanu R Ramprasath, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Agriculture and Agri-Food Canada
name: Sijo Joseph, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramprasath VR, Thandapilly SJ, Yang S, Abraham A, Jones PJ, Ames N. Effect of consuming novel foods consisting high oleic canola oil, barley beta-glucan, and DHA on cardiovascular disease risk in humans: the CONFIDENCE (Canola Oil and Fibre with DHA Enhanced) study - protocol for a randomized controlled trial. Trials. 2015 Oct 31;16:489. doi: 10.1186/s13063-015-1014-5.