跳至主要内容
临床试验/NCT03534414
NCT03534414Unknown不适用

Effect of a Portfolio Dietary Pattern on Cardiometabolic Risk: A Systematic Review and Meta-analysis of Controlled Trials

University of Toronto1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1
试验地点
1
主要终点
Blood lipids - LDL-C

研究概览

简要总结

The European Association for the Study of Diabetes (EASD) guidelines have not made any specific recommendations regarding the Portfolio diet, a dietary pattern that includes nuts, viscous fibre, plant protein, and plant sterols. To update the recommendations, the Diabetes and Nutrition Study Group (DNSG) of the EASD commissioned a systematic review and meta-analysis using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to summarize the available evidence from controlled trials of the effect of the Portfolio dietary pattern on LDL-cholesterol (LDL-C) and other established cardiometabolic risk factors.

详细描述

Background: The Portfolio Dietary Pattern, which includes nuts, viscous fiber, plant protein, and plant sterols, has been shown to have a cholesterol-lowering effect similar to that of early statin medications. Despite the endorsement of the Portfolio Dietary Pattern by major international diabetes and cardiovascular guidelines, the European Association for the Study of Diabetes (EASD) guidelines for nutrition therapy have not made any specific recommendations for the Portfolio Dietary Pattern. The present systematic review and meta-analysis using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was thus commissioned by the Diabetes and Nutrition Study Group (DNSG) of the EASD to summarize the available evidence from controlled trials of the effect of the Portfolio dietary pattern on LDL-cholesterol (LDL-C) and other established cardiometabolic risk factors.

Need for proposed research: High quality systematic reviews and meta-analyses of controlled trials represent the highest level of evidence to support dietary guidelines and public health policy development. As dietary guidelines and public health policy have shifted toward food and dietary-pattern based recommendations, there is a need for a systematic review and meta-analysis assessing the pooled effect of the Portfolio Dietary Pattern trials on cholesterol and cardiometabolic risk factors.

Objective: The investigators will conduct a systematic review and meta-analysis to summarize the effect of a Portfolio Dietary Pattern compared to control on lipids and other cardiometabolic risk factors in controlled clinical trials.

Design: The systematic review and meta-analysis will be conducted according to the Cochrane Handbook for Systematic Reviews of Interventions and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).

Data sources: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials will be searched using appropriate search terms supplemented by hand searches of references of included studies. Authors will be contacted for applicable missing data.

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

  • Trials in humans
  • Randomized and non-randomized controlled trials
  • Assessment of the portfolio dietary pattern in comparison to caloric- and macronutrient-matched diets that were not intended to provide components of the portfolio dietary pattern
  • Diet duration ≥ 4 week
  • Viable outcome data with ≥ 1 outcome of interest

排除标准

  • Non-human trials
  • Observational studies
  • Lack of suitable comparator diet
  • Diet duration <4 weeks
  • No viable outcome data

结局指标

主要结局

Blood lipids - LDL-C

时间窗: Up to 20 years

次要结局

  • Blood lipids - non-HDL-C(Up to 20 years)
  • Blood pressure - systolic blood pressure(Up to 20 years)
  • Coronary heart disease (CHD) risk(Up to 10 years)
  • Blood lipids - HDL-C(Up to 20 years)
  • Blood lipids - triglycerides(Up to 20 years)
  • Blood pressure - diastolic blood pressure(Up to 20 years)
  • Glycemic control - fasting blood insulin(Up to 20 years)
  • Glycemic control - HbA1c(Up to 20 years)
  • Blood lipids - Total-C(Up to 20 years)
  • Adiposity - body weight(Up to 20 years)
  • Glycemic control - fasting blood glucose(Up to 20 years)
  • Blood lipids - Apolipoprotein B (apo B)(Up to 20 years)
  • Inflammation - C-reactive protein(Up to 20 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Sievenpiper

Associate Professor

University of Toronto

研究点 (1)

Loading locations...

相似试验