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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

Ramprasath VR, Thandapilly SJ, Yang S, Abraham A, Jones PJ, Ames N

Trials · 7 citas

Etiquetas de revisión

Alimentación controlada

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Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento
Consumo medido con
Comida provista por los investigadores

Quién lo pagó

Financiación
Financiación independiente
Gobierno
Canadian Institutes of Health Research
Subvenciones
Canadian Institutes of Health Research (312802)

Según 1 financiador declarado y la declaración de financiación del texto completo.

Publicación

Publicado
2015-10-31 · Trials · vol. 16 · número 1 · pág. 489
Editorial
Springer Science+Business Media
Citado
10 citas · más que el 75% de estudios similares · 0.8× el promedio de su campo
Referencias
46 trabajos
Acceso
Acceso abierto (revista) · CC-BY
Áreas de investigación
Fatty Acid Research and Health · Nutritional Studies and Diet · Food composition and properties
Palabras clave
cardiovascular risk, metabolic syndrome, docosahexaenoic acid, barley β-glucan, novel foods, LDL particle size, LDL subfractions, blood pressure, lipid profile, inflammatory status, plasma fatty acid profile, fecal microbiota, cholesterol biosynthesis, dietary intervention
MeSH
humans, hordeum, cardiovascular diseases, beta-glucans, docosahexaenoic acids, fatty acids, monounsaturated, oleic acid, treatment outcome, clinical protocols, diet, risk factors, cross-over studies, single-blind method, nutritive value, research design, time factors, food, fortified, manitoba, metabolic syndrome, rapeseed oil

6 autores

  • Vanu Ramkumar Ramprasath🇨🇦University of Manitoba
  • Sijo Joseph Thandapilly🇨🇦Agriculture and Agri-Food Canada; University of Manitoba
  • Shuo Yang🇨🇦University of Manitoba
  • Anjalika Abraham🇨🇦University of Manitoba
  • Peter J.H. Jones🇨🇦University of Manitoba
  • Nancy P. Ames🇨🇦 · autor de correspondenciaAgriculture and Agri-Food Canada; University of Manitoba

Resumen

El texto original del estudio, en el idioma en que se publicó.

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/design

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.

Conclusion

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.

Trial registration

Clinical trials.gov identifier: NCT02091583 . Date of registration: 12 March 2014.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).

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