Canola Oil, Fibre and DHA Enhanced Clinical Trial

March 15, 2023 updated by: University of Manitoba

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 2N2
        • Richardson Centre for Functional Foods and Nutraceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
Fasting blood samples will be collected during the last 2 days of the four 4-week treatment phases over a period of seven months
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.
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
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.
Measurements will be done at the beginning and end of each of the four 4-week treatment phases over a period of seven months
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.
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 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 .
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Agriculture and Agri-Food Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2014:029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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