Meta-Analyses of the Effect of Vegetable Protein for Animal Protein on Cardiometabolic Risk

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canada Research Chairs Endowment of the Federal Government of Canada
Loblaw Companies Limited
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto
ClinicalTrials.gov Identifier:
NCT02037321
First received: January 13, 2014
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

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.


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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effect of Substituting Vegetable Protein for Animal-Protein on Cardiometabolic Risk: A Series of Systematic Reviews and Meta-Analyses of Controlled Feeding Trials to Provide Evidence-Based Guidance for Nutrition Guidelines Development

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Glycemic control analysis [ Time Frame: Up to 2-years ] [ Designated as safety issue: No ]
    Glycated blood proteins (HbA1c, total glycated hemoglobin, fructosamine, glycated albumin), fasting glucose, fasting insulin, and the homeostasis model assessment of insulin resistance (HOMA-IR)

  • Lipid control analysis [ Time Frame: Up to 2-years ] [ Designated as safety issue: No ]
    Established therapeutic targets for cardiovascular prevention (LDL-C, apoB, non-HDL-C)

  • Kidney function and injury analysis [ Time Frame: Up to 2-years ] [ Designated as safety issue: No ]
    creatinine, blood urea, creatine clearance (CrCl), estimated glomerular filtration rate (eGFR), albumin-to-creatine ratio (ACR), albuminuria, proteinuria

  • Body weight analysis [ Time Frame: Up to 2-years ] [ Designated as safety issue: No ]
    body weight

  • Blood Pressure (BP) Analysis [ Time Frame: Up to 2-years ] [ Designated as safety issue: No ]
    Systolic BP, diastolic BP, mean arterial pressure (MAP)

  • Uric acid analysis [ Time Frame: Up to 2-years ] [ Designated as safety issue: No ]
    uric acid

  • Non-alcoholic fatty liver disease (NAFLD) analysis [ Time Frame: Up to 2-years ] [ Designated as safety issue: No ]
    Imaging and spectroscopy endpoints of liver fat and biomarkers of hepatocellular injury (transaminases])


Estimated Enrollment: 1
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Varied

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-human studies
  • Nonrandomized treatment allocation
  • <3 weeks
  • Lack of a suitable control (i.e. no exchange with animal-protein)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037321

Locations
Canada, Ontario
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, Canada, M5C 2T2
Sponsors and Collaborators
John Sievenpiper
Canadian Institutes of Health Research (CIHR)
Canada Research Chairs Endowment of the Federal Government of Canada
Loblaw Companies Limited
Investigators
Principal Investigator: 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
Study Director: 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
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: John Sievenpiper, Knowledge Synthesis Lead, University of Toronto
ClinicalTrials.gov Identifier: NCT02037321     History of Changes
Other Study ID Numbers: MetaVeg2013
Study First Received: January 13, 2014
Last Updated: January 13, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Toronto:
Systematic review and meta-analysis

Additional relevant MeSH terms:
Cardiovascular Diseases
Fatty Liver
Hypertension
Kidney Diseases
Liver Diseases
Obesity
Dyslipidemias
Glucose Intolerance
Prediabetic State
Overweight
Metabolic Syndrome X
Wounds and Injuries
Digestive System Diseases
Vascular Diseases
Urologic Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Glucose Metabolism Disorders
Diabetes Mellitus
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on August 26, 2014