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About PERSUADED

LIFE PERSUADED Project overview

LIFE PERSUADED Phthalates and bisphenol A biomonitoring in Italian mother-child pairs: link between exposure and juvenile diseases - LIFE13 ENV/IT/000482

SUMMARY DESCRIPTION OF THE PROJECT

OBJECTIVES


Phthalates and Bisphenol A (BPA), extensively used as plasticizers, are non-persistent environmental contaminants whose well documented presence in humans raises concern since they act as endocrine disrupters (EDs), thus potentially affecting human health. EDs exposure during childhood deserves special attention since this represents a crucial susceptible phase of development. Recent studies have associated the exposure to di(2-ethylhexyl)phthalate) (DEHP) and BPA to development of endocrine related diseases in children, in particular for altered timing of puberty and obesity, thus posing the subjects at increased risk for type 2 diabetes and cardiovascular diseases. Precocious puberty and childhood obesity are multi-factorial diseases and growing attention has been paid to EDs exposure. In Italy, 10% of children aged 6-10 years are obese; changes in the timing of puberty markers currently affects 1/5000 children, being more common in girls. No national data exist up to now on levels of DEHP, and its metabolites (MEHP and secondary metabolites) and BPA in toddlers, children and adolescents nor on associations between exposure and such diseases.

Thus, the main objectives of the project can be summarized as follows:

1. to estimate internal levels of DEHP’s metabolites and BPA in vulnerable and susceptible groups of population such as children and adolescents, and their mothers, useful indicators of lifestyles and diet;
2. to evaluate exposure differences in urban and rural areas in North, Centre and South Italy;
3. to investigate the relationship between DEHP’s metabolites and/or BPA internal levels and idiopathic premature thelarche, idiopathic central precocious puberty and children idiopathic obesity;
4. to integrate internal EDs levels with biomarkers of effect related to such diseases, as proxy of potential adverse outcomes;
5. to evaluate clear cause-effects due to BPA/DEHP exposure in experimental conditions by a juvenile toxicity study in rodents, as innovative animal model for childhood diseases;
6. to improve risk assessment integrating human and experimental data and to identify effective measures to reduce the exposure;
7. to disseminate project’s results, criteria, outcomes to main stakeholders, including local health system operators, the general public, the media, and NGOs.
8. to network with DEMOCOPHES partners in order to compare results and implement the EU database on DEHP’s metabolites and BPA internal levels in mother-child pairs.


ACTIONS AND MEANS INVOLVED:

Action B1. Human biomonitoring study

A cross-sectional study will involve children and adolescents (males and females), aged 4-6, 7-10, 11- 14 years, and their mothers. A total of 4320 subjects will be enrolled from urban and rural areas defined according to population density (> or < 150 inhabitants/Kmsq) in North, Centre and South Italy. According to DEMOCOPHES, inclusion criteria and questionnaire to be filled by enrolled subjects will be defined.

Action B2. Case-control study on idiopathic premature thelarche and idiopathic central precocious puberty; Action B3. Case-control studies on idiopathic obesity in children
Two pilot case-control studies will be carried out on idiopathic premature thelarche and precocious puberty (a minimum of 30 girls each group, aged 2-7 years) and idiopathic obesity (a minimum of 30 boys and 30 girls, aged 6-10 years).

Action B4. Assessment of contaminants in human samples
Urine samples will be collected and analyzed for BPA, DEHP and its metabolites levels by LC-ESI-MS.

Action B5. Data management and statistical analysis
Data analysis will be carried out taking into account the DEMOCOPHES analysis plan. Both descriptive and inferential statistics will be performed to assess the correlation between EDs levels, biomarkers, exposures and considered health outcomes.

Action B6. Juvenile rodent toxicological study to evaluate the effect of exposure to BPA and DEHP mixtures derived from the Italian children biomonitoring study
A juvenile toxicity study will be carried out. Rats will be exposed for 28 days to mixtures of BPA and DEHP at dose levels recorded in children population. Markers of sexual development will be recorded. At sacrifice, blood and tissue samples will be collected to evaluate DEHP/MEHP/BPA-responsive reproductive and metabolic biomarkers, histopathological findings and selected genes expression.

Action B7. Clinical biomarkers evaluation; Action B8. Toxicological biomarkers evaluation
A panel of clinical and toxicological biomarkers related to puberty onset and obesity will be assessed in serum samples.

Action C1. Monitoring of the impact of the project
The impact of the project actions will be monitored.

Actions D. Communication and dissemination actions
D1. Project Website; D2. Notice Boards; D3. Layman's report; D4. Newsletters; D5. Leaflets; D6. Workshops and conference; D7. Dissemination activities; D8. Facebook page

Project findings will be disseminated to general public, scientific and technical communities and stakeholders at both national and EU level through website, notice board and layman’s report. In addition, seminars, conferences and workshops will be held. Newsletter, flyers, posters, brochures and research briefs will be produced for a broader audience.

E. Project management and monitoring of the project progress
E1. Project management; E2. Networking with other projects; E3. After LIFE communication plan

Project management and monitoring of its progress networking and After LIFE communication plan.


EXPECTED RESULTS (outputs and quantified achievements):

PERSUADED will provide the following results:

  • the setting of reference ranges for DEHP and BPA exposure in Italian children and women, also according to the area of residence. Biomonitoring data will contribute to develop biomonitoring equivalents (BE) for BPA and DEHP in juvenile and in women as a tool to support risk management, as required by REACH;
  • information on environmental characteristics, food habits and lifestyles as sources of EDs exposure from structured questionnaires;
  • the risk assessment related to premature thelarche, precocious puberty and juvenile obesity associated to EDs exposure. HBM1 and HMB2 reference values will be suggested on the basis of results;
  • the definition of a panel of biomarkers specifically correlated to BPA/DEHP human exposure and health status;
  • data on DEHP and BPA exposure specifically related to postnatal developmental life stages by the juvenile toxicity study;
  • the assessment of the reliability and sensitivity of the panel of biomarkers selected in case-control studies;
  • descriptive analysis and measures of association for the chemicals in the population according to age, gender and area of residence;
  • measures of association and relative risks of the chemicals exposure with pathological conditions in the different groups of cases;
  • analysis to define relationship between outcomes and level of exposure to chemicals in rats;
  • a dedicated website, in English and Italian, implemented and updated weekly with project information;
  • notice boards (24) will be displayed in locations of the beneficiaries and units involved in PERSUADED and located at project’s conference and workshops;
  • Layman’s report (N° 200 copies circulated), leaflets (about 400/pediatrician) and Newsletters (21 issues) will be produced, uploaded on the website and sent to a mailing list (1000 contacts) including EDs researchers medical and consumers associations;
  • Facebook page will be set up
  • three workshops will be organized to disseminate to the general public (1), to stakeholders (1) and scientific community (1);
  • a conference (1) will be held at the end of the project;
  • at least 5 peer-reviewed scientific publications will be produced

Documents

Published 22-09-2014 in About PERSUADED , last update 14-11-2016

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