The main objective is to determine the difference in serum POP concentrations in two groups of Dutch men consuming eel, namely the men consuming eel from polluted areas ('high* exposed) and those men consuming eel from clean areas (*low*…
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Brief title
Condition
- Other condition
Synonym
Health condition
Deze studie heeft niet direct betrekking op een aandoening.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome is the difference in serum POP concentrations in two
groups of Dutch men consuming eel, namely the men consuming eel from polluted
areas ('high* exposed) and those men consuming eel from clean areas (*low*
exposed).
Secondary outcome
The secondary study outcomes are concentrations of thyroid hormones, retinol,
insulin, glucose, cholesterol HDL, haematocrit, platelet count, testosterone
and parameters for liver toxicity. In isolated peripheral blood mononuclear
cells (PBMCs), DNA methylation patterns will be assessed. When a relationship
between POP concentrations and DNA methylation is found, we will also measure
gene expression levels.
Background summary
Seafood is considered to be beneficial for human health, but fish consumption
also contributes to increased plasma levels of persistent organic pollutants
(POPs). In the Biesbosch area eel fishing is prohibited since 2011. Before
2011, eel caught in this area was consumed for years, while the POP levels in
eel were above the European legal limit. POPs degrade very slowly, and
accumulate and cicrulate for years in exposed people. These pollutants are
related to many adverse health effects, but it is not known whether negative
health effects can be found in Dutch men consuming (polluted) eel every month.
The mechanisms of action of POPs are not yet completely elucidated. This is
difficult due to health effects that can occur long after exposure to these
compounds started. Earlier animal research showed that some health effects
might be explained by epigenetic mechanisms. Changes in DNA methylation is an
epigenetic mechanism that is known to be associated with various health
effects. High concentrations of POPs have been associated with aberrant global
DNA methylation in several epidemiological studies. As far as known, no
research has been conducted to investigate the relationship between POP levels
and gene-specific DNA methylation.
We hypothesize that men consuming eel from polluted areas have higher internal
POP concentrations than men consuming eel from less polluted or clean areas.
Furthermore, we hypothesize that internal POP concentrations are correlated to
relevant biological outcomes, like hormone levels, and to aberrant DNA
methylation.
Study objective
The main objective is to determine the difference in serum POP concentrations
in two groups of Dutch men consuming eel, namely the men consuming eel from
polluted areas ('high* exposed) and those men consuming eel from clean areas
(*low* exposed).
The secondary objective is to correlate internal POP concentrations to
biomarkers linked with health outcomes. Furthermore, we will try to correlate
internal POP concentrations to gene-specific DNA methylation.
Study design
This is a cross-sectional study.
Study burden and risks
Subjects have to complete a short questionnaire, before they can enrol in this
study. This will take approximately 15 minutes. Blood (±75 mL) will be
withdrawn once by venipuncture in the arm of the volunteer. The risk of this is
negligible and the burden is minimal. The subject*s length, body weight, and
waist- and hip circumference will be assessed.
Tuinlaan 5
Wageningen 6703HE
NL
Tuinlaan 5
Wageningen 6703HE
NL
Listed location countries
Age
Inclusion criteria
Male
Age between 40 and 70 years
Consumption of eel >= 1x per month
Exclusion criteria
There are no exclusion criteria.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46740.081.14 |