Effect of Soy Milk for Cow's Milk on Intermediate Cardiometabolic Outcomes: 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: 2023年3月6日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: University of Toronto
入组人数: 1
试验地点: 1
主要终点: Blood lipids - Apolipoprotein B (ApoB)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Dairy consumption has shown associations with decreased incidence of cardiometabolic diseases. With the growing interest in plant-based eating, and the mounting evidence for the cardiovascular benefits of plant forward diets, national dietary guidelines have pivoted away from promoting exclusive daily dairy consumption. Soymilk is the most nutritionally comparable non-dairy plant-based alternative to cow's milk. Although the DGA, Health Canada, and various pediatric associations recognize fortified soymilk as the only non-dairy alternative equivalent to cow's milk and it can carry an approved health claim for coronary heart disease risk reduction based on the soy protein that it contains, soymilk is classified by the NOVA classification as an ultra-processed food (the opposite of the classification of cow's milk as an unprocessed or minimally processed food). To be an acceptable iso-sweet alternative to cow's milk, soymilk is also often sweetened with sucrose, which is designated as an added sugar, whereas the lactose that sweetens cow's milk is not (despite lactose in cow's milk being present in quantities that are double that of sucrose in soymilk products designed to be iso-sweet analogues of cow's milk). With near universal recommendations from major public health authorities to reduce the intake of both ultra-processed foods and added sugars and the FDA proposing to update its "healthy" claim criteria to limit added sugars, the role of soymilk as a "healthy" non-dairy alternative to cow's milk is in serious question. The effect of soy protein on other cardiometabolic outcomes is also unclear. To address this question and better inform health claims and guideline development, the investigators will conduct a systematic review and meta-analysis of randomized controlled trials of the effect of soy protein as soy milk, in substitution for cow's milk, on various intermediate cardiometabolic mediators.

详细描述

RATIONALE. Soymilk and other processed soy products are at an important crossroads. Although the DGA, Health Canada, and various pediatric associations recognize fortified soymilk as the only non-dairy plant milk alternative equivalent to cow's milk and it can carry an approved health claim for coronary heart disease risk reduction based on the soy protein that it contains, soymilk is classified by the NOVA classification as an ultra-processed food (the opposite of the classification of cow's milk as an unprocessed or minimally processed food). To be an acceptable iso-sweet alternative to cow's milk, soymilk is also often sweetened with sucrose, which is designated as an added sugar, whereas the lactose that sweetens cow's milk is not (despite lactose in cow's milk being present in quantities that are double that of sucrose in soymilk products designed to be iso-sweet analogues of cow's milk). With near universal recommendations from major public health authorities to reduce the intake of both ultra-processed foods and added sugars and the FDA updating its "healthy" claim criteria to limit added sugars, the role of soymilk as a "healthy" non-dairy alternative to cow's milk is in serious question.

OBJECTIVES. The objective is to conduct a systematic review and meta-analysis of randomized controlled trials to assess the effect of soymilk in substitution for cow's milk and its modification by added sugars (sweetened versus unsweetened) on established cardiometabolic risk factors of clinical and public health importance 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 milk in substitution for cow's milk on cardiometabolic risk factors 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 milk intervention
•Cow's milk 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
•Multimodal interventions
•Lack of suitable comparator
•Intervention duration < 3 weeks
•No viable outcome data