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Completed

NCT Number: NCT02091583

Canola Oil, Fibre and DHA Enhanced Clinical Trial

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

Primary outcomes

  1. 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

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

Secondary outcomes

  1. 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

    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.

  2. 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

    Determination of inflammatory markers and cytokines will be measured by commercially available ELISA kits.

  3. 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

    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.

  4. 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

    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.

  5. 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

    Blood pressure data (change in both systolic and diastolic) was taken 4 times at 2-minutes intervals. The last 3 measurements will be averaged.

  6. 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

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

  7. 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

    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 .

  8. 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

    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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Agriculture and Agri-Food Canada
  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2019
First posted
Mar 19, 2014
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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