Dietary mycotoxin exposure and human health risks: A protocol for a systematic review.

BACKGROUND: Mycotoxins are toxic fungal secondary metabolites that contaminate a wide spectrum of essential foods worldwide, such as grain-based products, nuts and spices, causing adverse health effects pertaining to their carcinogenic, nephrotoxic and hepatotoxic nature, among others. AIM: The aim of this systematic review (SR) is to systematically search for, appraise and synthesize primary research evidence to identify what is known about dietary mycotoxin-related health effects and what remains unknown, as well as the uncertainty around findings and the recommendations for the future. SEARCH STRATEGY AND ELIGIBILITY CRITERIA: Search strategies, as well as eligibility criteria were structured according to a predefined PECO (population, exposure, comparison, and outcome) research question and developed in an iterative scoping process. Several bibliographic databases, including Embase, Cochrane Library, Pubmed, Web of Science Core Collection and Scopus, will be searched. Primary research on any measured or modelled dietary exposure to a single or multiple mycotoxins, and adverse human health outcomes (i.e. cancer, non-carcinogenic diseases, and reproductive & developmental adverse outcomes) will be included, and references will be imported into Covidence. In vitro, ex vivo, in silico, animal and review studies, as well as expert's opinions, secondary literature, conference abstracts, presentations, posters, book chapters, dissertations and studies involving non-dietary mycotoxin exposure, will be excluded. STUDY SELECTION: Two independent reviewers will screen titles and abstracts, and review full-texts. Any disagreements will be resolved by a third reviewer based on two-third majority. DATA EXTRACTION: Data from retained eligible studies will be extracted by the principal reviewer, and peer-checked by a second reviewer. STUDY QUALITY ASSESSMENT: Eligible studies will be evaluated for risk of bias (Overall High-Quality Assessment Tool, OHAT) and certainty of evidence (Grading of Recommendations Assessment, Development and Evaluation, GRADE). EVIDENCE SYNTHESIS: A detailed summary of the included studies will be provided within a tabular format and narratively discussed. Heat maps will be constructed to provide information on available knowledge (gaps), and a meta-analysis may be performed based on the variability in predefined PECO elements and depending on the heterogeneity of studies. CONCLUSION: This protocol describes the methodology for the conduct of a SR on mycotoxin-related human health risks, that could guide future research and inform regulatory decisions, as emphasized by the European Commission within the field of regulatory risk assessment for emerging chemicals.

Burden of disease associated with dietary exposure to carcinogenic aflatoxins in Portugal using human biomonitoring approach.

Human biomonitoring is an important tool to assess human exposure to chemicals, contributing to describe trends of exposure over time and to identify population groups that could be under risk. Aflatoxins are genotoxic and carcinogenic food contaminants causing hepatocellular carcinoma, the third leading cause of cancer deaths worldwide. In Portugal, scarce data are available regarding exposure to aflatoxins and no previous study used human biomonitoring data to comprehensively characterize the associated burden of disease. 24 h urine and first-morning urine paired samples were collected by 94 participants and were analyzed by liquid chromatography-tandem mass spectrometry for the quantitative determination of aflatoxins (B1, B2, G1, G2 and M1). Deterministic and probabilistic models were developed to assess the Portuguese exposure to aflatoxins and to estimate the health impact of this exposure, estimating the attributed Disability-Adjusted Life Years (DALYs). Aflatoxins were detected in a maximum of 13% (AFB1), 16% (AFB2), 1% (AFG1), 2% (AFG2) and 19% (AFM1) of the urine samples. Data obtained through the probabilistic approach revealed an estimated mean probable daily intake of 13.43 ng/kg body weight per day resulting in 0.13 extra cases of hepatocellular carcinoma, corresponding to mean annual DALYs of 172.8 for the Portuguese population (10291027 inhabitants). The present study generated for the first time and within a human biomonitoring study, reliable and crucial data to characterize the burden associated to the exposure to aflatoxins of the Portuguese population. The obtained results constitute an imperative support to risk managers in the establishment of preventive policy measures that contribute to ensure public health protection.