Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT02037321

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

AgeNot listed to Not listed
SexAll
Healthy volunteersNot accepted
ConditionDiabetes, Prediabetes, Metabolic Syndrome, Dysglycemia, Overweight, Obesity, Dyslipidemia, Hypertension, Gout, Non-alcoholic Fatty Liver Disease (NAFLD), Kidney Disease, Kidney Injury, Cardiovascular Disease, Inflammation

Full registry 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)

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Glycemic control analysisUp to 2-years

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 analysisUp to 2-years

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

Kidney function and injury analysisUp to 2-years

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

Body weight analysisUp to 2-years

body weight

Blood Pressure (BP) AnalysisUp to 2-years

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

Uric acid analysisUp to 2-years

uric acid

Non-alcoholic fatty liver disease (NAFLD) analysisUp to 2-years

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

Inflammation marker, C-reactive protein (CRP)Up to 2-years

CRP

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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