Canola Oil, Fibre and DHA Enhanced Clinical Trial

This study is currently recruiting participants. (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 14, 2015
Last verified: March 2014
  Purpose

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.


Condition Intervention
Metabolic Syndrome
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

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 synthesis rate [ 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 ] [ Designated as safety issue: No ]
    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.

  • 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 plasma insulin concentration [ 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 ]
    Insulin homeostasis modelling assessment will be utilised as an estimate for % β-cell function and insulin resistance.

  • Plasma and RBC fatty acid analysis [ 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 ]
    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 .

  • Microbiome analysis [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 35
Study Start Date: November 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Butter, sunflower and safflower oil
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
Active Comparator: High Oleic Canola Oil and DHA (HOCO-DHA)
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)
Active Comparator: Barley Beta-glucan
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
Active Comparator: HOCO-DHA and Barley beta-glucan
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

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

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 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 14, 2015
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
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases

ClinicalTrials.gov processed this record on June 28, 2015