Canola Oil, Fibre and DHA Enhanced Clinical Trial

NCT02091583 | Completed

• 1 other identifier: B2014:029
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 management of heart disease risk factors in people with metabolic syndrome and to test its efficacy and safety in humans.

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome; Cardiovascular disease; High Oleic Canola Oil; DHA; β-glucan; Barley; Cholesterol; Lipoproteins; Lipids; Inflammation; Glucose; Insulin; Satiety; Body composition; Blood pressure

Outcome Measures

Primary Outcomes (1)

• Change in 10-year Framingham CVD risk score

  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 Outcomes (8)

• Change in blood lipid profile (TC, TG, LDL-C, HDL-C)

  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

  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

  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

  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

  Measurements will be done at the beginning and end of each of the four 4-week treatment phases over a period of seven months

Study Arms (4)

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.

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.

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.

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.

Dietary Supplement: HOCO-DHA and Barley beta-glucan

Interventions

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Agriculture and Agri-Food Canada: collaborator

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

• 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.

  PMID: 26518870 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Cardiovascular Diseases; Inflammation; Insulin Resistance

Interventions

Butter; Safflower Oil

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fats, Unsaturated; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Peter JH Jones, PhD

  Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 19, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: August 1, 2019
• Last Updated: March 17, 2023

Record last verified: 2021-04

Locations

CA (1)