Meta-Analyses of the Effect of Plant Protein Versus Animal Protein on Cardiometabolic Risk

NCT02037321 | Active Not Recruiting

• 1 other identifier: CIHR-Plant vs animal protein
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Vegetarian diets have been associated with a reduced risk of preventable diseases such as type 2 diabetes and cardiovascular disease. These effects may be mediated through direct or indirect pathways. Although the high intakes of nuts, legumes, dietary fibre, whole grains, and unsaturated plant oils have each individually been associated with lower risk of type 2 diabetes and cardiovascular disease, so too has the displacement of red meats, processed meats, and saturated animal fats. One of the most important considerations in moving from animal-based diets to more plant-based diets is the replacement of animal proteins (e.g. meat, fish, dairy, eggs) with vegetable proteins (e.g. legumes, nuts, and seeds). It is unclear whether this particular replacement alone results in advantages for metabolic and cardiovascular health. To improve evidence-based guidance for dietary guidelines and health claims development, we propose to conduct a series of systematic reviews and meta-analyses of the effect of plant-based protein in exchange for animal protein on blood lipids, glycemic control, blood pressure, body weight, uric acid, markers of non-alcoholic fatty liver disease (NAFLD), and kidney function and injury. The systematic review process allows the combining of the results from many small studies in order to arrive at a pooled estimate, similar to a weighted average, of the true effect. The investigators will be able to explore whether the effects of replacing animal-based protein for plant-based protein hold true across different sexes, age groups, and background disease states and whether the effect depends on the protein source, dose, or background diet. The findings of this proposed knowledge synthesis will help improve the health of Canadians through informing recommendations for the general public, as well as those at risk of heart disease and diabetes.

Conditions

Diabetes; Prediabetes; Metabolic Syndrome; Dysglycemia; Overweight; Obesity; Dyslipidemia; Hypertension; Gout; Non-alcoholic Fatty Liver Disease (NAFLD); Kidney Disease; Kidney Injury; Cardiovascular Disease; Inflammation

Keywords

Systematic review and meta-analysis

Outcome Measures

Primary Outcomes (8)

• Glycemic control analysis

  Glycated blood proteins (HbA1c, total glycated hemoglobin, fructosamine, glycated albumin), fasting glucose, fasting insulin, and the homeostasis model assessment of insulin resistance (HOMA-IR)

  Up to 2-years

• Lipid control analysis

  Established therapeutic targets for cardiovascular prevention (LDL-C, apoB, non-HDL-C)

  Up to 2-years

• Kidney function and injury analysis

  creatinine, blood urea, creatine clearance (CrCl), estimated glomerular filtration rate (eGFR), albumin-to-creatine ratio (ACR), albuminuria, proteinuria

  Up to 2-years

• Body weight analysis

  body weight

  Up to 2-years

• Blood Pressure (BP) Analysis

  Systolic BP, diastolic BP, mean arterial pressure (MAP)

  Up to 2-years

• Uric acid analysis

  uric acid

  Up to 2-years

• Non-alcoholic fatty liver disease (NAFLD) analysis

  Imaging and spectroscopy endpoints of liver fat and biomarkers of hepatocellular injury (transaminases\])

  Up to 2-years

• Inflammation marker, C-reactive protein (CRP)

  CRP

  Up to 2-years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Varied

You may qualify if:

• Dietary trials in humans
• Randomized treatment allocation
• \>=3 weeks
• Suitable control (i.e. exchange with animal-protein)
• Viable endpoint data

You may not qualify if:

• Non-human studies
• Nonrandomized treatment allocation
• \<3 weeks
• Lack of a suitable control (i.e. no exchange with animal-protein)

Sponsors & Collaborators

• John Sievenpiper: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canada Research Chairs Endowment of the Federal Government of Canada: collaborator
• Loblaw Companies Limited: collaborator

Study Sites (1)

Toronto 3-D (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 (2)

• Li SS, Blanco Mejia S, Lytvyn L, Stewart SE, Viguiliouk E, Ha V, de Souza RJ, Leiter LA, Kendall CWC, Jenkins DJA, Sievenpiper JL. Effect of Plant Protein on Blood Lipids: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2017 Dec 20;6(12):e006659. doi: 10.1161/JAHA.117.006659.

  PMID: 29263032 DERIVED

• Viguiliouk E, Stewart SE, Jayalath VH, Ng AP, Mirrahimi A, de Souza RJ, Hanley AJ, Bazinet RP, Blanco Mejia S, Leiter LA, Josse RG, Kendall CW, Jenkins DJ, Sievenpiper JL. Effect of Replacing Animal Protein with Plant Protein on Glycemic Control in Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients. 2015 Dec 1;7(12):9804-24. doi: 10.3390/nu7125509.

  PMID: 26633472 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Prediabetic State; Metabolic Syndrome; Overweight; Obesity; Dyslipidemias; Hypertension; Gout; Non-alcoholic Fatty Liver Disease; Kidney Diseases; Cardiovascular Diseases; Inflammation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Vascular Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fatty Liver; Liver Diseases; Digestive System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes

Study Officials

• John L Sievenpiper, MD, PhD

  Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital and Department of Pathology and Molecular Medicine, Faculty of health Sciences, McMaster University

  PRINCIPAL INVESTIGATOR

• Russell J de Souza, ScD, RD

  Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital and Department of Epidemiology and Biostatistics, McMaster University

  STUDY DIRECTOR

• Cyril WC Kendall, PhD

  Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital and Department of Nutritional Sciences and Medicine, University of Toronto

  STUDY DIRECTOR

• David JA Jenkins, MD, PhD, DSc

  Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital and Department of Nutritional Sciences and Medicine, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Knowledge Synthesis Lead

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: May 1, 2013
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-06

Locations

CA (1)