Metabolic SyndromeNCT02091583

Canola Oil, Fibre and DHA Enhanced Clinical Trial

A study testing Butter, sunflower and safflower oil, High Oleic Canola Oil and DHA (HOCO-DHA) and Barley beta-glucan in people with Metabolic Syndrome, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Metabolic Syndrome
What is being tested?: Butter, sunflower and safflower oil, High Oleic Canola Oil and DHA (HOCO-DHA) and Barley beta-glucan
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteCanada
Study dates: Nov 2014to Aug 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

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

Read the 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.

Conditions: Metabolic Syndrome
Being tested: Butter, sunflower and safflower oil, High Oleic Canola Oil and DHA (HOCO-DHA), Barley beta-glucan, HOCO-DHA and Barley beta-glucan
Keywords: Metabolic syndrome, Cardiovascular disease, High Oleic Canola Oil, DHA, β-glucan, Barley, Cholesterol, Lipoproteins, Lipids, Inflammation, Glucose, Insulin, Satiety, Body composition, Blood pressure
Medical subject headings: Metabolic Syndrome, Cardiovascular Diseases, Inflammation, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Butter, sunflower and safflower oilDietary supplement
High Oleic Canola Oil and DHA (HOCO-DHA)Dietary supplement
Barley beta-glucanDietary supplement
HOCO-DHA and Barley beta-glucanDietary supplement

Study groups in NCT02091583
Study group	Role	What they receive
Butter, sunflower and safflower oil	Placebo comparator	The oil (50g/day) is given in muffin and cookies made with refined wheat flour (3 g/day)daily for 4 weeks. Receives: Dietary Supplement: Butter, sunflower and safflower oil
High Oleic Canola Oil and DHA (HOCO-DHA)	Active comparator	The oil (50g/day) is given in muffin and cookies made with refined wheat flour (3 g/day) daily for 4 weeks. Receives: Dietary Supplement: High Oleic Canola Oil and DHA (HOCO-DHA)
Barley Beta-glucan	Active comparator	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. Receives: Dietary Supplement: Barley beta-glucan
HOCO-DHA and Barley beta-glucan	Active comparator	The oil and beta-glucan (50g and 3g/day, respectively) is given in muffin and cookies daily for 4 weeks. Receives: Dietary Supplement: HOCO-DHA and Barley beta-glucan

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in 10-year Framingham CVD risk score
Change in 10-year Framingham CVD risk will be assessed using the multivariable Framingham risk equation.
Measured: 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 (8)

Change in blood lipid profile (TC, TG, LDL-C, HDL-C)
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.
Measured: 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
Determination of inflammatory markers and cytokines will be measured by commercially available ELISA kits.
Measured: 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
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.
Measured: 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
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.
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
Blood pressure data (change in both systolic and diastolic) was taken 4 times at 2-minutes intervals. The last 3 measurements will be averaged.
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
Fasting plasma insulin concentration
Insulin homeostasis modelling assessment will be utilised as an estimate for % β-cell function and insulin resistance.
Measured: 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
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 .
Measured: 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
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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Aug 2019

First posted19 Mar 2014 (estimated)
Study startNov 2014
Primary completionNov 2015
Study completionAug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
More trials run by University of ManitobaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02091583
Sponsor's protocol ID: B2014:029
Status last verified: Apr 2021
First submitted: 12 Mar 2014
Last updated: 17 Mar 2023
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 26518870

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02091583
Acronym / sponsor ID: B2014:029
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome, Cardiovascular disease, High Oleic Canola Oil, DHA, β-glucan, Barley, Cholesterol, Lipoproteins
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of ManitobaUniversity, hospital or other
Collaborators: Canadian Institutes of Health Research (CIHR), Agriculture and Agri-Food Canada
Study start: Nov 2014
Primary completion: Nov 2015 (actual)
Study completion: Aug 2019 (actual)
First posted: 19 Mar 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Butter, sunflower and safflower oil	Placebo comparator	Dietary Supplement: Butter, sunflower and safflower oilThe oil (50g/day) is given in muffin and cookies made with refined wheat flour (3 g/day)daily for 4 weeks.
High Oleic Canola Oil and DHA (HOCO-DHA)	Active comparator	Dietary Supplement: 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.
Barley Beta-glucan	Active comparator	Dietary Supplement: Barley beta-glucanThe 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.
HOCO-DHA and Barley beta-glucan	Active comparator	Dietary Supplement: HOCO-DHA and Barley beta-glucanThe oil and beta-glucan (50g and 3g/day, respectively) is given in muffin and cookies daily for 4 weeks.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

BMI≥25 Kg/m2
Waist circumference ≥94 cm (males) or ≥80 cm (females)
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

Key exclusion criteria (8 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Butter, sunflower and safflower oil	Dietary supplement	Butter, sunflower and safflower oil
High Oleic Canola Oil and DHA (HOCO-DHA)	Dietary supplement	High Oleic Canola Oil and DHA (HOCO-DHA)
Barley beta-glucan	Dietary supplement	Barley Beta-glucan
HOCO-DHA and Barley beta-glucan	Dietary supplement	HOCO-DHA and Barley beta-glucan

Primary outcome

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.

8 secondary outcomes

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
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
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
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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
Derived from this study: PubMed 26518870Ramprasath 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter JH Jones, PhD study chair

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Nancy Ames, PhD principal investigator

Agriculture and Agri-Food Canada

Vanu R Ramprasath, PhD principal investigator

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02091583, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.