Canola Oil, Fibre and DHA Enhanced Clinical Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by University of Manitoba
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT02091583
First received: March 12, 2014
Last updated: April 9, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to examine the effects of consumption of a novel supplement beverage 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.


Condition Intervention
Metabolic Syndrome
Dietary Supplement: Corn and safflower oil
Dietary Supplement: High Oleic Canola Oil and DHA (HOCO-DHA)
Dietary Supplement: Barley beta-glucan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developing and Evaluating a Novel Supplement Beverage, Consisting of Canola Oil, Fibre and DHA, Aiming at the Management of CVD Risk in a Population With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Change in 10-year Framingham CVD risk score [ 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 ] [ Designated as safety issue: No ]
    Change in 10-year Framingham CVD risk will be assessed using the multivariable Framingham risk equation.


Secondary Outcome Measures:
  • Change in blood lipid profile (TC, TG, LDL-C, HDL-C) [ 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 ] [ Designated as safety issue: No ]
    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.

  • Change in inflammatory markers [ 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 ] [ Designated as safety issue: No ]
    Determination of inflammatory markers and cytokines will be measured by commercially available ELISA kits.

  • Cholesterol absorption and synthesis rate [ Time Frame: Fasting blood samples will be collected during the last 6 days of the four 4-week treatment phases over a period of seven months ] [ Designated as safety issue: No ]
    Participants will be asked to consume 13C-cholesterol and deuterium oxide (D2O) at the end of each phase. On day 23, fasting blood samples will be obtained (0h), prior to oral administration of a 75mg of 13C-cholesterol mixed in 5g of margarine and spread on half English muffin. Fasting samples will be obtained over the following 96 hours on day 24 (24h), day 25 (48h), day 26 (72h) and day 27 (96h) to measure cholesterol absorption. In addition, on day 27 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 28.

  • Change in body composition [ 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 ] [ Designated as safety issue: No ]
    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.

  • Blood Pressure [ 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 ] [ Designated as safety issue: No ]
    Blood pressure data (change in both systolic and diastolic) was taken 4 times at 2-minutes intervals. The last 3 measurements will be averaged.

  • Fasting insulin and glucose and insulin homeostasis modelling assessment (HOMA) [ 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 ] [ Designated as safety issue: No ]
    Insulin concentrations will be determined using ELISA kits. Glucose concentrations will be determined using a finger-prick blood glucose monitor. In addition, glucose response to breakfast will be assess before and at 15, 30, 45, 60, 90 and 120 minutes following the initiation of breakfast.

  • Satiety [ Time Frame: Assessment will be done at the end of the four 4-week treatment phases over a period of seven months ] [ Designated as safety issue: No ]
    Participants will be given 30 minutes to consume the full portion of their prescribed treatment. At 60 minutes after treatment participants will be instructed to eat until they reached a point of comfortable satisfaction. Food intake and level of comfortably full will be assessed by questionnaire. In addition, a visual analogue scale (VAS) questionnaire will be used to measure motivation to eat before and after an all you can eat meal.


Estimated Enrollment: 35
Study Start Date: April 2014
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Corn and safflower oil
The oil (60 g/d/3000 kcal) is given in two daily fruit beverage for 4 weeks.
Dietary Supplement: Corn and safflower oil
Active Comparator: High Oleic Canola Oil and DHA (HOCO-DHA)
The oil (60 g/d/3000 kcal) is given in two daily fruit beverage for 4 weeks.
Dietary Supplement: High Oleic Canola Oil and DHA (HOCO-DHA)
Active Comparator: Barley Beta-glucan
The Barley beta-glucan (3 g/d/3000 kcal) is given in two daily fruit beverage for 4 weeks.
Dietary Supplement: Barley beta-glucan
Active Comparator: HOCO-DHA and Barley beta-glucan
The oil and beta-glucan (60g and 3g/d/3000 kcal, respectively) is given in two daily fruit beverage for 4 weeks.
Dietary Supplement: High Oleic Canola Oil and DHA (HOCO-DHA) Dietary Supplement: Barley beta-glucan

Detailed Description:

The proposed study is a randomized, double-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 28 days per phase, each phase will be separate by 4-week washout periods. Participants will consume a controlled weight-maintaining diet (35% energy from fat, 50% carbohydrate, 15% protein) supplemented with the following novel beverages: (a) control beverage containing corn and safflower oil comprised largely of saturated fat with substantial levels of n-6 linoleic acid, common to current North American intakes, (b) beverage containing high oleic canola oil and docosahexaenoic acid (HOCO-DHA), (c) beverage containing high molecular weight barley B-glucan, (d) beverage containing combination of HOCO-DHA and high molecular weight barley β-glucan. Treatments will be isocalorically incorporated into fruit beverage made with fruit juice and consumed in equal parts at breakfast and supper.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02091583

Contacts
Contact: Peter JH Jones, PhD 2044748883 Peter.Jones@umanitoba.ca
Contact: Vanu Ramprasath, PhD 2044749989 vanu_ramprasath@umanitoba.ca

Locations
Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals Not yet recruiting
Winnipeg, Manitoba, Canada, R3T 2N2
Contact: Peter Jones, PhD    204-474-8883    peter_jones@umanitoba.ca   
Sponsors and Collaborators
University of Manitoba
Canadian Institutes of Health Research (CIHR)
Agriculture and Agri-Food Canada
Investigators
Study Chair: Peter JH Jones, PhD Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Principal Investigator: Nancy Ames, PhD Agriculture and Agri-Food Canada
Principal Investigator: Vanu R Ramprasath, PhD Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Principal Investigator: Sijo Joseph, PhD Agriculture and Agri-Food Canada
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02091583     History of Changes
Other Study ID Numbers: B2014:029
Study First Received: March 12, 2014
Last Updated: April 9, 2014
Health Authority: Canada: Public Health Agency of Canada

Keywords provided by University of Manitoba:
Metabolic syndrome
Cardiovascular disease
High Oleic Canola Oil
DHA
β-glucan
Barley
Cholesterol
Lipoproteins
Lipids
Inflammation
Glucose
Insulin
Satiety
Body composition
Blood pressure

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014