The Effect of Soy and Soy Products Consumption on Inflammatory Biomarkers: Protocol for a Systematic Review and Meta-analysis

Abstract

Background: Inflammation is a process that occurs in early phase of recovery in which immune system recognizes and removes immunological stimuli. Many chronic diseases have inflammation based pathogenesis. Several studies used soy and soy products for reducing inflammatory biomarkers.
 Objectives: The purpose of the present systematic review and meta-analysis of randomized clinical trials is to determine the effects of soy and soy products on inflammatory biomarkers.
 Methods: The following databases will be investigated for randomized controlled trials published until October 2019 to evaluate the effects of soybean and soy products on the inflammatory biomarkers in healthy subjects and patients with high inflammatory biomarkers: PubMed, Scopus, ISI Web of Science and Google scholar.Two independent investigators (M.R and F.M) will screen the title and the abstract of included articles. Mean and standard deviation (SD) or standard error (SE) for outcomes will be extracted. The quality of studies will be assessed by Cochrane Risk of Bias Tool. STATA software will be used to do a standard statistical analysis. A subgroup analysis will be applied to find out potential sources of inter-study heterogeneity. A Random-effects model will be conducted to calculate pooled effect size. A fixed-effect model will be incorporated to estimate the between-subgroup heterogeneity. Moreover, sensitivity analyses, Egger's regression asymmetry test and Begg's rank-correlation methods will be conducted.
 Results: We will try to find a major number of articles about the effectiveness of soy and soy products on inflammatory biomarkers. Tumor necrosis factor α (TNF-α), interleukine 6 (IL-6), interleukine 2 (IL-2), interleukine 1-β (IL-1β), interferon-gamma (IFN-γ) and Interleukine 10 (IL-10) are considered to be the outcome.
 Conclusion: The findings of this systematic review and meta-analysis may provide evidence on the effectiveness and safety of soy and soy products for reducing inflammation.