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临床试验/NCT04245826
NCT04245826Unknown不适用

Changing or Substituting Low-calorie Sweetened Beverages for Sugar-Sweetened Beverages or Water and Cardiometabolic Outcomes: A Systematic Review and Meta-analysis of Prospective Cohort Studies

University of Toronto1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年5月16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
Global measures of adiposity with established clinical relevance - body weight

研究概览

简要总结

We propose to conduct a systematic literature review and meta-analysis to assess the association of low-calorie sweetened beverages (LCSBs) on cardiometabolic outcomes in prospective cohort studies. We will be using methodological approaches (change in LCSBs intake, and/or substitution analysis) that attempt to overcome the issue of reverse causality associated with studies of LCSBs and cardiometabolic disease. Ten cardiometabolic outcomes will be assessed:

  1. Global adiposity - body weight
  2. Global adiposity - BMI
  3. Global adiposity - body fat
  4. Abdominal adiposity - waist circumference
  5. Overweight/obesity incidence
  6. Metabolic syndrome incidence
  7. Type 2 diabetes incidence
  8. Cardiovascular disease incidence
  9. Cardiovascular disease mortality
  10. Total mortality

详细描述

Background:

Low-calorie sweetened beverages (LCSBs) may provide a potentially important means for displacing excess calories from free sugars in the diet. However, prospective cohort studies suggest that the use of LCSBs may contribute to an increased risk of obesity and diabetes. These findings are likely due to methodological limitations of study design and analysis that do not account for reverse causality, where higher risk of cardiometabolic outcomes may lead to people to switch to LCSBs. There is a need for a systematic review and meta-analysis (SRMA) of prospective cohort studies to overcome these methodological limitations.

Objective:

We will conduct a SRMA of prospective cohort studies in human subjects that have assessed cardiometabolic outcomes using two analytical strategies:

i) Assessment of change in intake of LCSBs with change in outcome (change analysis)

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Prospective cohorts studies
  • Duration: more than 1 year follow-up
  • Exposure: LCSBs
  • Change analysis or substitution analysis of exposure

排除标准

  • Non-human studies
  • Less than 1 year follow-up
  • Analysis of baseline or prevalent intake of exposure only

结局指标

主要结局

Global measures of adiposity with established clinical relevance - body weight

时间窗: More than 1 year

Change in body weight

Global measures of adiposity with established clinical relevance - BMI

时间窗: More than 1 year

Change in body mass index (BMI)

Global measures of adiposity with established clinical relevance - body fat

时间窗: More than 1 year

Change in body fat

Abdominal measures of adiposity with established clinical relevance - waist circumference

时间窗: More than 1 year

Change in waist circumference

Overweight/obesity incidence

时间窗: More than 1 year

Risk ratio of Overweight/obesity incidence

Metabolic syndrome incidence

时间窗: More than 1 year

Risk ratio of metabolic syndrome incidence

Type 2 diabetes incidence

时间窗: More than 1 year

Risk ratio of type 2 diabetes incidence

Cardiovascular disease incidence

时间窗: More than 1 year

Risk ratio of cardiovascular disease incidence

Cardiovascular disease mortality

时间窗: More than 1 year

Risk ratio of Cardiovascular disease mortality

Total mortality

时间窗: More than 1 year

Risk ratio of total mortality

次要结局

未报告次要终点

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)

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