Meta-analysis of Oat Fiber and Cardiovascular Risk Reduction

NCT05171283 | Active Not Recruiting

• 1 other identifier: CIHR - Oats and CVD Risk
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Oat fibre has been shown to lower cholesterol and may have cardioprotective effects. However, whether this translates to actual cardiovascular risk reduction is unclear, as there is a lack of controlled human trials. To address this uncertainty, the investigator proposes to use established cardiovascular disease risk scores, such as those recommended by the Canadian Cardiovascular Society and other clinical practice groups, to create composite risk scores in assessing future risk. The data on oat fibre will be collected through a systematic review of controlled trials, composite cardiovascular risk scores will be calculated for each eligible study, and meta-analyses will be conducted to assess the overall effect. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence-based guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.

Conditions

Cardiovascular Diseases; Coronary Heart Disease

Keywords

Oat; Oat fibre; beta-glucan; Avena sativa; Systematic reviews and meta-analysis; Clinical practice guidelines; Controlled trials; Cardiovascular disease; Coronary heart disease; 10-year cardiovascular risk score

Outcome Measures

Primary Outcomes (1)

• Framingham Risk Score (FRS)

  Framingham Risk Score (FRS) calculates 10-year cardiovascular risk using the Cox formula which includes age, sex, total cholesterol, HDL-cholesterol, systolic blood pressure, blood pressure medication use, diabetes status, smoking status; minimum score 0%, maximum score 100% where higher score indicates higher risk of 10-year risk of cardiovascular disease

  >= 3-weeks

Secondary Outcomes (2)

• ACC/AHA ASCVD risk estimator

  >= 3-weeks

• Systematic COronary Risk Evaluation (SCORE)

  >= 3-weeks

Other Outcomes (3)

• Modifiable components of the risk scores - total-cholesterol

  >= 3-weeks

• Modifiable components of the risk scores - HDL-cholesterol

  >= 3-weeks

• Modifiable components of the risk scores - systolic blood pressure

  >= 3-weeks

Interventions

Oats or Oat Fibre OTHER

Interventions that contain whole grain oats or oat beta-glucan.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any population type.

You may qualify if:

• Dietary trials in humans
• Randomized treatment allocation
• ≥3 weeks
• Intervention with oats or oat beta-glucan
• Suitable control (i.e. isocaloric diet that is not vegetarian or vegan)
• Ascertainment of viable outcome data for cardiovascular risk calculations

You may not qualify if:

• Non-human studies
• Non-randomized treatment allocation
• \<3 weeks
• No intervention of oats or oat beta-glucan
• Lack of a suitable control (i.e. non-isocaloric)
• No viable endpoint data

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Quaker Oats Centre of Excellence, Quaker: collaborator

Study Sites (1)

The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (18)

• Food Directorate Health Products and Food Branch, Health Canada Oat products and blood cholesterol lowering Bureau of Nutritional Sciences, Ottawa (2010). Available at https://www.canada.ca/en/health-canada/services/food-nutrition/food-labelling/health-claims/assessments/products-blood-cholesterol-lowering-summary-assessment-health-claim-about-products-blood-cholesterol-lowering.html

  BACKGROUND

• U.S. Food & Drug Administration, Health and Human Services. Food Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease. 21 CFR Part 101 [Docket No. 01Q-0313]. Available at https://www.gpo.gov/fdsys/pkg/FR-2002-10-02/pdf/02-25067.pdf

  BACKGROUND

• EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Scientific Opinion on the substantiation of a health claim related to oat beta-glucan and lowering blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006 EFSA J, 8 (12) (2010), p. 1885, 10.2903/j.efsa.2010.1885 Available at www.efsa.europa.eu/efsajournal.htm

  BACKGROUND

• Ference BA, Cannon CP, Landmesser U, Luscher TF, Catapano AL, Ray KK. Reduction of low density lipoprotein-cholesterol and cardiovascular events with proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors and statins: an analysis of FOURIER, SPIRE, and the Cholesterol Treatment Trialists Collaboration. Eur Heart J. 2018 Jul 14;39(27):2540-2545. doi: 10.1093/eurheartj/ehx450. No abstract available.

  PMID: 29020411 BACKGROUND

• Ference BA, Robinson JG, Brook RD, Catapano AL, Chapman MJ, Neff DR, Voros S, Giugliano RP, Davey Smith G, Fazio S, Sabatine MS. Variation in PCSK9 and HMGCR and Risk of Cardiovascular Disease and Diabetes. N Engl J Med. 2016 Dec 1;375(22):2144-2153. doi: 10.1056/NEJMoa1604304.

  PMID: 27959767 BACKGROUND

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  PMID: 26888710 BACKGROUND

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  PMID: 26201847 BACKGROUND

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  PMID: 29127271 BACKGROUND

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  PMID: 24239921 BACKGROUND

• Anderson TJ, Gregoire J, Pearson GJ, Barry AR, Couture P, Dawes M, Francis GA, Genest J Jr, Grover S, Gupta M, Hegele RA, Lau DC, Leiter LA, Lonn E, Mancini GB, McPherson R, Ngui D, Poirier P, Sievenpiper JL, Stone JA, Thanassoulis G, Ward R. 2016 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult. Can J Cardiol. 2016 Nov;32(11):1263-1282. doi: 10.1016/j.cjca.2016.07.510. Epub 2016 Jul 25.

  PMID: 27712954 BACKGROUND

• Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Monique Verschuren WM, Vlachopoulos C, Wood DA, Luis Zamorano J; Additional Contributor; Cooney MT. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Rev Esp Cardiol (Engl Ed). 2017 Feb;70(2):115. doi: 10.1016/j.rec.2017.01.002. No abstract available. English, Spanish.

  PMID: 29389351 BACKGROUND

• Ho HV, Sievenpiper JL, Zurbau A, Blanco Mejia S, Jovanovski E, Au-Yeung F, Jenkins AL, Vuksan V. The effect of oat beta-glucan on LDL-cholesterol, non-HDL-cholesterol and apoB for CVD risk reduction: a systematic review and meta-analysis of randomised-controlled trials. Br J Nutr. 2016 Oct;116(8):1369-1382. doi: 10.1017/S000711451600341X. Epub 2016 Oct 11.

  PMID: 27724985 BACKGROUND

• Hollaender PL, Ross AB, Kristensen M. Whole-grain and blood lipid changes in apparently healthy adults: a systematic review and meta-analysis of randomized controlled studies. Am J Clin Nutr. 2015 Sep;102(3):556-72. doi: 10.3945/ajcn.115.109165. Epub 2015 Aug 12.

  PMID: 26269373 BACKGROUND

• Khan K, Jovanovski E, Ho HVT, Marques ACR, Zurbau A, Mejia SB, Sievenpiper JL, Vuksan V. The effect of viscous soluble fiber on blood pressure: A systematic review and meta-analysis of randomized controlled trials. Nutr Metab Cardiovasc Dis. 2018 Jan;28(1):3-13. doi: 10.1016/j.numecd.2017.09.007. Epub 2017 Oct 7.

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  PMID: 15369167 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Disease; Gyrate Atrophy

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Eye Diseases, Hereditary; Eye Diseases; Choroid Diseases; Uveal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• John L Sievenpiper, PhD, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 28, 2021
• Study Start: November 1, 2021
• Primary Completion: May 30, 2024
• Study Completion: December 1, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)