A Meta-analysis of 46 Studies Identified by the FDA on the Effect of Soy Protein on Lipid Markers (LDL-Cholesterol [LDL-C] and Total Cholesterol [TC]) as Surrogates of Cardiovascular Disease

Background: The FDA in their re-evaluation of the scientific evidence for a relationship between soy protein and reduced risk of coronary heart disease (CHD), has revised the data included in the 1999 soy protein and CHD health claim, as well as studies published after this authorized health claim and concluded that a heart health claim is no longer justified based on more recent studies. The 46 identified studies have not been meta-analyzed.

Need for proposed research: To meta-analyse the 46 identified studies to provide the highest level of evidence to aid in the final decision of the soy protein and reduced risk of CHD health claim.

Objective: To provide evidence-based guidance for publich health policy, health claims, and nutrition guidelines relating to soy, we will conduct a meta-analysis of the 46 FDA identified studies of the effect of soy protein on surrogate markers of cardiovascular disease.

Design: The conduct of the meta-analysis will follow the Cochrane handbook for Systematic Reviews of interventions. The reporting will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines.

Data sources and study selection: We will include the 46 studies pre-selected by the FDA in the Proposed Rule, Soy Protein and Coronary Heart Disease (Docket No. FDA-2017-N-0763).