Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2, Canada
NCT Number: NCT02091583
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Winnipeg, Manitoba, R3T 2N2, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Meet at least two of the following:
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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 .
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
University of Manitoba
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT06186102
Arterial Occlusive Diseases, Arteriosclerosis
Aarhus, Jutland, Denmark
View Trial DetailsNCT07241741
Body Weight, C-reactive Protein
View Trial DetailsNCT05563584
Arterial Occlusive Diseases, Arteriosclerosis
Bath, United Kingdom
View Trial DetailsNCT03841786
Cardiovascular Diseases, Glucose Metabolism Disorders
Birmingham, Alabama, United States
View Trial Details