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临床试验/NCT02037321
NCT02037321进行中(未招募)不适用

Effect of Substituting Plant 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

John Sievenpiper1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2013年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1
试验地点
1
主要终点
Glycemic control analysis

研究概览

简要总结

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.

详细描述

Background: Vegetarian diets have been associated with a reduced risk of preventable cardiometabolic diseases such as type 2 diabetes and cardiovascular disease. It is unclear whether the replacement of animal protein with vegetable protein has cardiometabolic advantages.

Objectives: 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 effects of plant-based protein in replacement for animal protein on cardiometabolic risk factors including: (1) blood lipids, (2) glycemic control, (3) blood pressure, (4) body weight, (5) uric acid, (6) markers of non-alcoholic fatty liver disease (NAFLD), (7) kidney function and injury, and (8) CRP as an inflammation marker.

Design: The planning and conduct of the proposed meta-analyses will follow the Cochrane handbook for systematic reviews of interventions. The reporting will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines.

Data sources: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials will be searched using appropriate search terms.

Study selection: Long term (≥ 3 weeks), randomized, controlled trials that investigate the effect of exchange of plant proteins for animal proteins on the outcomes previously mentioned in humans will be included. Studies that have an acute feeding design, are not randomized, or lack a suitable control will not be included. Both isocaloric and non-isocaloric studies will be included.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Glycemic control analysis

时间窗: Up 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 analysis

时间窗: Up to 2-years

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

Kidney function and injury analysis

时间窗: Up to 2-years

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

Body weight analysis

时间窗: Up to 2-years

body weight

Blood Pressure (BP) Analysis

时间窗: Up to 2-years

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

Uric acid analysis

时间窗: Up to 2-years

uric acid

Non-alcoholic fatty liver disease (NAFLD) analysis

时间窗: Up to 2-years

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

Inflammation marker, C-reactive protein (CRP)

时间窗: Up to 2-years

CRP

次要结局

未报告次要终点

研究者

发起方
John Sievenpiper
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

John Sievenpiper

Knowledge Synthesis Lead

University of Toronto

研究点 (1)

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