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临床试验/NCT02654535
NCT02654535已完成不适用

Nuts in Relation to Markers of Adiposity, Overweight, and Obesity: A Series of Systematic Reviews and Meta-analyses of Randomized Controlled Trials and Prospective Cohort Studies

John Sievenpiper1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
Incident overweight or obesity (prospective cohort studies)

研究概览

简要总结

Peanuts and tree nuts (almonds, pistachios, walnuts, pecans, pine nuts, Brazil nuts, cashews, hazelnuts, macadamia nuts) (herein referred to as "nuts") are a good source of unsaturated fatty acids, vegetable protein, fibre, and polyphenolics. Nut intake has been associated with reduced cardiovascular disease risk and claims for this association have been permitted by the FDA; however, intake of tree nuts is low in Canada. One of the barriers to increasing the consumption of nuts is the perception that they may contribute to weight gain more than other "healthy foods" owing to their high energy density. The evidence supporting this concern, however, is lacking. In a series of earlier systematic reviews and meta-analyses, we have shown that nuts improve glycemic control and metabolic syndrome criteria, findings which run contrary to any expected weight gain. However, it remains unclear whether nuts have an increasing, neutral, or even decreasing effect on body weight. To address the uncertainties, the investigators propose to conduct a series of systematic reviews and meta-analyses of the totality of the evidence from randomized controlled trials and prospective cohort studies to investigate the effect of nut consumption on body weight and adiposity. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence-based guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design

详细描述

Background: Peanuts and tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios and walnuts) are an important source of unsaturated fatty acids, vegetable protein, and fibre, as well as minerals, vitamins, and phytonutrients. The FDA has permitted health claims for tree nuts for cardiovascular disease risk reduction and the cardiovascular benefits of nuts is acknowledged [FDA, 2015; Bao et al., 2013; Sabate et al., 2010]; however, intake of tree nuts is low in Canada. Based on the 2004 Canadian Community Health Survey (CCHS), <5% of Canadians consumed nuts on any given day with a mean intake of 18 g/day in those consuming nuts [PHAC, 2004]. This intake level is far below the 42 g/day amount recommended by the FDA for cardiovascular risk reduction. One of the barriers to increasing the consumption of nuts is the perception that they may contribute to weight gain more than other "healthy foods" owing to their high energy density. With the rise in overweight and obesity and its downstream cardiometabolic complications, heart and diabetes associations have cautioned against the over consumption of nuts at the same time that they recommend them for heart health [Sievenpiper et al., 2013; Evert et al., 2014; Anderson et al., 2013]. In a series of earlier systematic reviews and meta-analyses, we have shown that nuts improve glycemic control and metabolic syndrome criteria, findings which run contrary to any expected weight gain [Viguiliouk et al., 2014; Blanco Mejia et al., 2014]. Although an earlier systematic review and meta-analysis of controlled trials showed a lack of effect of nut intake on body weight [Flores-Mateo et al., 2013], it remains unclear whether nuts have an increasing, neutral, or even decreasing effect on a broader set of markers of adiposity.

Need for proposed research:The lack of high quality syntheses and knowledge translation to reconcile the benefits of nuts with potential weight gain represents an urgent call for stronger evidence. High quality systematic reviews and meta-analyses of randomized controlled trials and prospective cohort studies represent the highest level of evidence to support dietary guidelines and public health policy development.

Objective: The investigators will conduct a series of systematic reviews and meta-analyses to (1) distinguish the effect of peanuts and tree nuts on body weight and markers of adiposity in randomized controlled trials and (2) assess peanut and tree nut consumption with incident overweight/obesity and changes in weight and markers of adiposity in prospective cohort studies.

Design: Each 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) [Higgins et al., 2011; Moher et al., 2009].

Data sources: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (Clinical Trials; CENTRAL) will be searched using appropriate search terms supplemented by hand searches of references of included studies.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incident overweight or obesity (prospective cohort studies)

时间窗: Up to 40 years

Incident overweight or obesity

Body weight (randomized controlled trials)

时间窗: Up to 40 years

Body weight

次要结局

  • Global measures of adiposity with established clinical relevance - BMI (prospective cohort studies and randomized controlled trials)(Up to 40 years)
  • Global measures of adiposity with established clinical relevance - body fat (prospective cohort studies and randomized controlled trials)(Up to 40 years)
  • Regional measures of adiposity with established clinical relevance - waist circumference (prospective cohort studies and randomized controlled trials)(Up to 40 years)
  • Regional measures of adiposity with established clinical relevance - waist-to-hip ratio (prospective cohort studies and randomized controlled trials)(Up to 40 years)
  • Global measures of adiposity with established clinical relevance - body weight (prospective cohort studies)(Up to 40 years)
  • Regional measures of adiposity with established clinical relevance - visceral adipose tissue (prospective cohort studies and randomized controlled trials)(Up to 40 years)

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

Associate Professor

University of Toronto

研究点 (1)

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