title: Effect of consuming novel foods consisting high oleic canola oil, barley β-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.
abstract: BACKGROUND
  Metabolic syndrome (MetS) has been identified as a major contributor to the development of cardiovascular disease (CVD). Current recommendations for dietary management of people with MetS involve quantitative and qualitative modifications of food intake, such as high consumption of vegetables, fruits, and whole grain foods. The results from our previous human trials revealed the potential of the dietary components high-oleic acid canola oil (HOCO)-docosahexaenoic acid (DHA) and high molecular weight barley β-glucan individually in managing CVD risk factors. Foods with a combination of HOCO-DHA and barley β-glucan have never been tested for their effects on CVD risk. The objective is to determine the effects of consuming novel foods HOCO-DHA, and barley β-glucan on managing CVD risk factors in people with MetS.
  
  
  METHODS
  We are conducting a randomized, single-blind crossover trial with four treatment phases of 28 days each separated by a 4-week washout interval. Participants (n=35) will be provided with weight-maintaining, healthy balanced diet recommendations according to their energy requirements during the intervention periods. Participants will receive muffins and cookies as treatment foods in a random order and will consume at least one meal per day at the research center under supervision. The four treatments include muffins and cookies consisting of (1) all-purpose flour and HOCO-DHA (50 g/day); (2) barley flour (4.36 g/day of β-glucan) and a blend of sunflower oil, safflower oil, and butter as control oil (50 g/day); (3) barley flour (4.36 g/day of β-glucan) and HOCO-DHA (50 g/day; dosage of DHA would be 3 g/day); and (4) all-purpose flour and control oil (50 g/day). At the beginning and end of each phase, we will evaluate anthropometrics; systolic and diastolic blood pressure; blood lipid profile; low-density lipoprotein subfractions and particle size; 10-year Framingham CVD risk score; inflammatory status; and plasma and red blood cell fatty acid profiles, fecal microbiome, and body composition by dual-energy X-ray absorptiometry.
  
  
  CONCLUSIONS
  Cholesterol synthesis will also be studied, using a stable isotope approach. The proposed study will lead to innovation of novel food products, which may result in improvement in the overall cardiovascular health of humans.
  
  
  BACKGROUND
  Clinical trials.gov identifier: NCT02091583 . Date of registration: 12 March 2014.
authors.affiliation: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, 196 Innovation Drive, Winnipeg, MB, R3T 2N2, Canada. vanu_ramprasath@umanitoba.ca.|Department of Human Nutritional Sciences, University of Manitoba, Winnipeg, MB, Canada. vanu_ramprasath@umanitoba.ca.
authors.forename: Vanu R
authors.initials: VR
authors.lastname: Ramprasath
authors.affiliation: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, 196 Innovation Drive, Winnipeg, MB, R3T 2N2, Canada. sijo.thandapilly@agr.gc.ca.|Department of Human Nutritional Sciences, University of Manitoba, Winnipeg, MB, Canada. sijo.thandapilly@agr.gc.ca.|Agriculture and Agri-Food Canada, Winnipeg, MB, Canada. sijo.thandapilly@agr.gc.ca.
authors.forename: Sijo J
authors.initials: SJ
authors.lastname: Thandapilly
authors.affiliation: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, 196 Innovation Drive, Winnipeg, MB, R3T 2N2, Canada. shuo.yang@umanitoba.ca.|Department of Human Nutritional Sciences, University of Manitoba, Winnipeg, MB, Canada. shuo.yang@umanitoba.ca.
authors.forename: Shuo
authors.initials: S
authors.lastname: Yang
authors.affiliation: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, 196 Innovation Drive, Winnipeg, MB, R3T 2N2, Canada. abrahaas@myumanitoba.ca.|Department of Human Nutritional Sciences, University of Manitoba, Winnipeg, MB, Canada. abrahaas@myumanitoba.ca.
authors.forename: Anjalika
authors.initials: A
authors.lastname: Abraham
authors.affiliation: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, 196 Innovation Drive, Winnipeg, MB, R3T 2N2, Canada. peter_jones@umanitoba.ca.|Department of Human Nutritional Sciences, University of Manitoba, Winnipeg, MB, Canada. peter_jones@umanitoba.ca.
authors.forename: Peter J H
authors.initials: PJ
authors.lastname: Jones
authors.affiliation: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, 196 Innovation Drive, Winnipeg, MB, R3T 2N2, Canada. nancy.ames@agr.gc.ca.|Department of Human Nutritional Sciences, University of Manitoba, Winnipeg, MB, Canada. nancy.ames@agr.gc.ca.|Agriculture and Agri-Food Canada, Winnipeg, MB, Canada. nancy.ames@agr.gc.ca.
authors.forename: Nancy
authors.initials: N
authors.lastname: Ames
mesh_terms: D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000517:prevention & control*; D002985:Clinical Protocols; D018592:Cross-Over Studies; D004032:Diet; D004281:Docosahexaenoic Acids / Q000008:administration & dosage*; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage*; D005527:Food, Fortified; D001467:Hordeum / Q000737:chemistry*; D006801:Humans; D008350:Manitoba; D024821:Metabolic Syndrome / Q000097:blood / Q000175:diagnosis / Q000178:diet therapy* / Q000503:physiopathology; D009753:Nutritive Value; D019301:Oleic Acid / Q000008:administration & dosage*; D000074262:Rapeseed Oil; D012107:Research Design; D012307:Risk Factors; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D047071:beta-Glucans / Q000008:administration & dosage* / Q000302:isolation & purification
chemical_list: D005229:Fatty Acids, Monounsaturated; D000074262:Rapeseed Oil; D047071:beta-Glucans; D004281:Docosahexaenoic Acids; D019301:Oleic Acid