Effect of Soy Protein and Its Food Sources on Established Therapeutic Blood Lipid Targets: A Systematic Review and Meta-analysis of Randomized Controlled Trials
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Blood lipids - LDL-Cholesterol (LDL-C)
研究概览
简要总结
Although soy protein has approved health claims in Canada and the US, and is recognized by major cardiovascular clinical practice guidelines for the reduction of cholesterol and risk of coronary heart disease (CHD), these claims are based almost exclusively on evidence from foods containing isolated soy protein (ISP). The role of other non-ISP food sources of soy protein (e.g Tofu, tempeh, edamame) in these effects is unclear. The role of food form and matrix (e.g soy beverage versus meat analogue) on the effects of ISP is also unclear. As national dietary guidelines and clinical practice guidelines for nutrition therapy shift from a focus on single nutrients to a focus on foods and dietary patterns, it is important to understand whether non-ISP food sources of soy protein and ISP food sources with different food matrices produce the same reductions in LDL-cholesterol and CHD risk. To strengthen the evidence-base for health claims and guidelines development, the investigators will conduct a systematic review and meta-analysis of randomized controlled trials of the effect of ISP and non-ISP food sources of soy protein on stablished lipid targets in individuals with and without dyslipidemia.
详细描述
RATIONALE. Although soy protein has approved health claims in Canada and the US and is recognized by major cardiovascular clinical practice guidelines for the reduction of cholesterol and risk of coronary heart disease (CHD), these claims are based almost exclusively on evidence from foods containing isolated soy protein (ISP). The role of other non-ISP food sources of soy protein (e.g Tofu, tempeh, edamame) in these effects is unclear. The role of food form and matrix (e.g soy beverage versus meat analogue) on the effects of ISP is also unclear. As national dietary guidelines and clinical practice guidelines for nutrition therapy shift from a focus on single nutrients to a focus on foods and dietary patterns, it is important to understand whether non-ISP food sources of soy protein and ISP food sources with different food matrices produce the same reductions in LDL-cholesterol and CHD risk. The investigators are not aware of any systematic reviews and meta-analyses of randomized controlled trials that have addressed this important question.
OBJECTIVES. To conduct a systematic review of the effect of soy protein with prespecified analyses by food source on established lipid targets in individuals with and without dyslipidemia and assess the certainty of the evidence using the Grading of Recommendations Assessment Development and Evaluation (GRADE) system. A sub-objective is to conduct a targeted systematic review and meta-analysis of the effect of exclusively ISP on established lipid targets in individuals with and without dyslipidemia for use in the development of Health Claims submissions in Australia and New Zealand by co-investigator, Dr. Alan Barclay.
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 (based on the FDA minimum follow-up requirement) assessing the effect of soy protein food sources compared with a suitable non-soy-containing control on lipids 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
- 是
入选标准
- •Randomized controlled trials
- •Soy protein (Isolated soy protein and non-isolated soy protein) intervention
- •Non-soy protein containing comparator
- •Intervention duration ≥ 3 weeks
- •Data for at least 1 outcome
排除标准
- •Non-human studies
- •Observational studies
- •Acute single-bolus feeding studies
- •Participants <18 years of age
- •Interventions of soy derivatives or extracts (i.e. soy oil, sterols, etc)
- •No quantification of soy protein in intervention
- •Multimodal interventions
- •Lack of a suitable comparator (i.e. a comparator arm that contains soy protein)
- •Intervention duration < 3 weeks
- •No viable outcome data
结局指标
主要结局
Blood lipids - LDL-Cholesterol (LDL-C)
时间窗: ≥ 3 weeks
LDL-C mean difference and 95%CIs in mmol/L
次要结局
- Blood lipids - HDL-Cholesterol (HDL-C)(≥ 3 weeks)
- Blood lipids - Triglycerides (TG)(≥ 3 weeks)
- Blood lipids - Total Cholesterol (TC)(≥ 3 weeks)
- Blood lipids - Non-HDL-Cholesterol (Non-HDL-C)(≥ 3 weeks)
- Blood lipids - Apolipoprotein B (Apo B)(≥ 3 weeks)
研究者
John Sievenpiper
Associate Professor
University of Toronto