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临床试验/NCT02879500
NCT02879500Unknown不适用

Effect of Artificially Sweetened Beverages on Cardiometabolic Risk Factors: A Series of Systematic Reviews and Network Meta-analyses of Randomized Controlled Trials

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11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1
试验地点
1
主要终点
Adiposity - Body weight

研究概览

简要总结

Sugars especially in form or sugar-sweetened beverages (SSBs) have been singled out as one of the prime culprits in the dual epidemics of obesity and diabetes. Artificially sweetened beverages (ASBs) provide a potentially important means for displacing excess calories from free sugars in the diet. There is, however, a concern that the use of ASBs may themselves contribute to an increased risk of obesity and diabetes. This concern led the 2015 Dietary Guidelines for American Committee (DGAC) to recommend that sugars in the diet not be replaced with ASBs but rather with "healthy options" such as water. Whether ASBs as a replacement strategy for SSBs have the intended benefits and whether these benefits are similar to those of the preferred replacement strategy water remains unclear. To address this important question and update of the European Association of the Study (EASD) clinical practice guidelines for nutrition therapy, the investigators propose to conduct a series of systematic reviews and network meta-analyses of the totality of the evidence from randomized controlled trials to evaluate the effects of water and ASBs on incident overweight and obesity and cardiometabolic risk factors. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence/base guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovations, and guiding future research design.

详细描述

Background: Sugars especially in form or sugar-sweetened beverages (SSBs) have been singled out as one of the prime culprits in the dual epidemics of obesity and diabetes. Artificially sweetened beverages (ASBs) provide a potentially important means for displacing excess calories from free sugars in the diet. There is, however, a concern that the use of ASBs may themselves contribute to an increased risk of obesity and diabetes. This concern led the 2015 Dietary Guidelines for American Committee (DGAC) to recommend that sugars in the diet not be replaced with ASBs but rather with "healthy options" such as water. Whether ASBs as a replacement strategy for SSBs have the intended benefits and whether these benefits are similar to those of the preferred replacement strategy water remains unclear.

Objective: To inform the update of the European Association of the Study (EASD) clinical practice guidelines for nutrition therapy, the investigators will conduct a series of systematic reviews and network meta-analyses to asses the effect of the substitution of ASBs for SSBs, water for SSBs, and ASBs for water on measures of adiposity and cardiometabolic risk factors.

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).

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. Abstracts will be included and no language restrictions will be used.

Study selection: The investigators will include randomized controlled trials (RCTs) that are >=7 days duration and assess the effect of water versus ASBs on incident overweight/obesity or cardiometabolic risk factors.

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
  • Diet beverage intervention
  • Water comparator
  • Diet duration >= 7 days
  • Viable outcome data

排除标准

  • Non-human trials
  • Observational studies
  • Lack of suitable comparator
  • Diet duration < 2 weeks
  • No viable outcome data
  • Cohort studies
  • Inclusion Criteria:
  • Prospective cohort studies or case-cohort studies
  • Duration >= 1year
  • Assessment of the exposure of diet beverages or water
  • Ascertainment of viable data by level of exposure
  • Exclusion Criteria:
  • Ecological, cross-sectional, and retrospective observational studies, clinical trials and non-human studies
  • Duration < 1 year
  • No assessment of exposures of diet beverages or water
  • No ascertainment viable clinical outcome data by level of exposure

结局指标

主要结局

Adiposity - Body weight

时间窗: Up to 20 years

body weight

次要结局

  • Adiposity - BMI(Up to 20 years)
  • Blood lipid targets - triglycerides(Up to 20 years)
  • Adiposity - Body fat(Up to 20 years)
  • Glycemic control - fasting plasma glucose (FPG)(Up to 20 years)
  • Glycemic control - fasting plasma insulin (FPI)(Up to 20 years)
  • Glycemic control - HbA1c(Up to 20 years)
  • Blood lipid targets - non-HDL-cholesterol (non-HDL-C)(Up to 20 years)
  • Blood lipid targets - apolipoprotein B (apo B)(Up to 20 years)
  • Markers of non-alcoholic fatty liver disease (NAFLD) - Intrahepatocellular lipids (IHCL)(Up to 20 years)
  • Adiposity - waist circumference (WC)(Up to 20 years)
  • Glycemic control - 2h plasma glucose (2h-PG)(Up to 20 years)
  • Blood lipid targets - HDL-cholesterol (HDL-C)(Up to 20 years)
  • Markers of non-alcoholic fatty liver disease (NAFLD) - alanine transaminase (ALT)(Up to 20 years)
  • Markers of non-alcoholic fatty liver disease (NAFLD) - aspartate transaminase (AST)(Up to 20 years)
  • Glycemic control - homeostasis model assessment of insulin resistance (HOMA-IR)(Up to 20 years)
  • Blood lipid targets - LDL-cholesterol (LDL-C)(Up to 20 years)
  • Blood pressure - Systolic blood pressure (SBP)(Up to 20 years)
  • Blood pressure - diastolic blood pressure (DBP)(Up to 20 years)
  • Uric acid(Up to 20 years)
  • Blood lipid targets - Total-cholesterol (Total-C)(Up to 20 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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