Canola Oil, Fibre and DHA Enhanced Clinical Trial

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091583
• Other study ID #: B2014:029
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: August 2019

Study information

• Verified date: April 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2019
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Butter, sunflower and safflower oil

• High Oleic Canola Oil and DHA (HOCO-DHA)

• Barley beta-glucan

• HOCO-DHA and Barley beta-glucan

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods and Nutraceuticals	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Agriculture and Agri-Food Canada, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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
Secondary	Change in inflammatory markers	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
Secondary	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.	Fasting blood samples will be collected during the last 2 days of the four 4-week treatment phases over a period of seven months
Secondary	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.	Measurements will be done at the beginning and end of each of the four 4-week treatment phases over a period of seven months
Secondary	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.	Measurements will be done at the beginning and end of each of the four 4-week treatment phases over a period of seven months
Secondary	Fasting plasma insulin concentration	Insulin homeostasis modelling assessment will be utilised as an estimate for % ß-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
Secondary	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 .	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
Secondary	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	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