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临床试验/NCT05638061
NCT05638061进行中(未招募)不适用

The Effect of Food Sources of Soy Protein on Blood Pressure: A Systematic Review and Meta-Analysis of Randomized 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: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1
试验地点
1
主要终点
Diastolic Blood Pressure (DBP)

研究概览

简要总结

Hypertension is one of the leading risk factors for death and significantly increases the risk for cardiovascular (CVD), brain and kidney diseases. It is also one of the leading modifiable risk factors for CVD, which also plays a significant role in the global burden of death and disease. Dietary guidelines for blood pressure management and hypertension emphasize fruits and vegetables, plant-based proteins and foods low in saturated fat. With the growing interest in plant-based alternatives and plant-based diets, there is a need to clarify their benefits on blood pressure. Soy protein is a complete protein and is the only plant-based beverage alternative that is comparable to dairy milk. There are mixed findings on the effects of soy on blood pressure due to differences in study design and subjects. To better address this question and inform public health guidelines the investigators will conduct a systematic review and meta-analysis of randomized controlled trials of the effect of soy protein on reducing blood pressure in individuals with and without hypertension.

详细描述

RATIONALE: Hypertension is one of the leading risk factors for death and significantly increases the risk for cardiovascular disease (CVD), brain and kidney diseases. It is also one of the leading modifiable risk factors for CVD. Dietary guidelines for blood pressure management and hypertension emphasize fruits and vegetables, plant-based proteins and foods low in saturated fat. With the growing interest in plant-based alternatives and plant-based diets, there is a need to clarify their benefits on blood pressure. Soy protein is a complete protein and is the only plant-based beverage alternative that is comparable to dairy milk. There are mixed findings on the effects of soy on blood pressure due to differences in study design and subjects. To better address this question and inform public health guidelines the investigators will conduct a systematic review and meta-analysis of randomized controlled trials of the effect of soy protein on reducing blood pressure in individuals with and without hypertension.

OBJECTIVES: To conduct a systematic review of the effect of soy protein by food source on systolic (SBP) and diastolic (DBP) blood pressure in individuals with and without hypertension and assess the certainty of the evidence using the Grading of Recommendations Assessment Development and Evaluation (GRADE) system.

DESIGN: The systematic review and meta-analyses 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 of references of included studies.

STUDY SELECTION: Randomized controlled trials of ≥3-weeks assessing the effect of soy protein food sources compared with a suitable non-soy-containing control group on blood pressure will be included.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Randomized Controlled Trials
  • Soy intervention
  • Non-soy comparator
  • Intervention duration >3 weeks
  • Data for >1 Outcome

排除标准

  • Observational Studies
  • Non-Human Studies
  • Lack of Suitable Comparator (i.e. soy-containing, equally matched doses)
  • Multimodal interventions
  • RCTs with participants < 18 years of age

结局指标

主要结局

Diastolic Blood Pressure (DBP)

时间窗: Immediately after the intervention

DBP mean difference and 95% CIs in mmHg

Systolic Blood Pressure (SBP)

时间窗: Immediately after the intervention

SBP mean difference and 95% CIs in mmHg

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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