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临床试验/NCT02779790
NCT02779790Unknown不适用

Effect of Liquid Meal Replacements on Cardiometabolic Risk Factors: A Series of Systematic Reviews and 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: 2016年4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
Established therapeutic lipid targets - HDL-cholesterol

研究概览

简要总结

Obesity is a major risk factor for cardiovascular disease and diabetes. Weight loss is an important therapeutic goal for overweight and obese patients to reduce their risk of developing cardiovascular disease and diabetes. Liquid meal replacements (LMRs) are simple tools that may aid in weight loss and may improve weight-related risk cardiometabolic risk factors. There is a need to synthesize the evidence on LMRs and cardiometabolic risk to inform clinical practice guidelines. The authors propose to conduct a series of systematic review and meta-analysis of randomized controlled trials to evaluate the effect of LMRs on 4 areas of cardiometabolic risk: markers of adipsoity, glycemic control, established lipid targets, and blood pressure.

详细描述

Background: Liquid meal replacements (LMRs) provide a mixture of carbohydrate, fat and protein, along with added vitamins and minerals in liquid ready-to-drink form or powder formulas that require mixing. They are designed to mimic a low-calorie meal and serve as a quick and easy source of calories to consume. Behavioral strategy tools are important to assist obese individuals in losing weight and maintaining weight loss. There is evidence that LMRs contribute to weight loss and may reduce related cardiometabolic risk factors.

Need for proposed research: An earlier meta-analysis demonstrated that partial meal replacement plans produced significant weight loss and improved weight-related cardiometabolic risk factors. Several controlled trials have since investigated the effect of liquid meal replacements on body weight and weight-related risk factors for disease. There is a need to update of the evidence of the effect of LMRs on cardiometabolic risk to inform dietary guidelines and public health policy development.

Objective: To synthesize the evidence of randomized controlled trials of the effect of LMRs on body weight, blood pressure, glycemic control and established lipid targets.

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 (Clinical Trials; CENTRAL) will be searched using appropriate search terms supplemented by manual searches.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Trials in humans
  • •Liquid meal replacement intervention
  • •Presence of a comparator diet (control diet)
  • •Diet duration >=2 weeks
  • •Viable outcome data

排除标准

  • •Non-human trials
  • •Observational studies
  • •Lack of suitable comparator diet
  • •No viable outcome data

结局指标

主要结局

Established therapeutic lipid targets - HDL-cholesterol

时间窗: Up to 20 years

HDL-cholesterol (HDL-C)

Established therapeutic lipid targets - triglycerides

时间窗: Up to 20 years

Triglycerides

Blood pressure - systolic blood pressure

时间窗: Up to 20 years

Systolic blood pressure

Markers of adiposity - body weight

时间窗: Up to 20 years

Body weight

Markers of adiposity - Body Mass Index

时间窗: Up to 20 years

Body Mass Index (BMI)

Markers of adiposity - body fat

时间窗: Up to 20 years

Body fat

Markers of adiposity - waist circumference

时间窗: Up to 20 years

Waist circumference

Glycemic control - HbA1c

时间窗: Up to 20 years

HbA1c

Glycemic control - fasting glucose

时间窗: Up to 20 years

fasting glucose

Glycemic control - fasting insulin

时间窗: Up to 20 years

fasting insulin

Established therapeutic lipid targets - LDL-cholesterol

时间窗: Up to 20 years

LDL-cholesterol (LDL-C)

Established therapeutic lipid targets - apolipoprotein B

时间窗: Up to 20 years

Apolipoprotein B (apo B)

Established therapeutic lipid targets - non-HDL-cholesterol

时间窗: Up to 20 years

non-HDL-cholesterol (non-HDL-C)

Blood pressure - diastolic blood pressure

时间窗: Up to 20 years

Diastolic blood pressure

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

Associate Professor

University of Toronto

研究点 (1)

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