Effects of Lifestyle Changes on Semen Quality in Healthy Young Men Living in Highly Polluted Areas (FAST)

Summary

We planned a randomized controlled trial (RCT) with the main aim to evaluate the effects of lifestyle changes on semen quality in healthy young men living in polluted areas in Italy. Secondary aims are to assess: a) the association between semen quality and biomarkers of early damage or inflammation; b) the associations between biomarkers of exposure to heavy metals and semen quality and biomarkers of early damage or inflammation; c) the associations between diet and physical activity and semen quality and biomarkers of early damage or inflammation; d) the effects of lifestyle changes on the blood and semen levels of heavy metals.

The RCT includes 450 young men living in one of the following three polluted areas:

1. a polychlorinated biphenyls (PCBs) polluted area in Brescia province, Lombardy region;
2. the valley of the Sacco river, with high levels of beta-hexachlorocyclohexane (β-HCH) originated by toxic waste dumps of industrial origin.
3. the "Land of Fires" in the Campania region, with a high concentration of illegal waste dumping and uncontrolled burning near cultivated fields.

Inclusion criteria are: a) healthy males aged 18- 22 years; b) residents in the area since at least 5 years; c) non smokers; d) non alcohol or drug users; e) normo-weight (18.5\< BMI\<24.99); f) no occupationally exposed to fertility toxics; g) not affected by chronic diseases. Subjects will be randomly assigned to an intervention or control group. The intervention group will follow a nutritional pathway and receive suggestions on practice of physical activity for 4 months, under the guide of some nutritionists, who will establish individualized diets for each subject. The control group will receive only a booklet including the dietary recommendations by the Italian National Institute for Research on Food and Nutrition. All subjects will undergo urologic examination, measurement of weight, height and abdominal circumference, an interview on demographic data, lifestyle variables, dietary habits, adherence to Mediterranean diet and physical activity, and will provide blood and semen samples in fasting conditions, at the enrollment (baseline), at the end of the intervention phase (after 4 months) and at the end of follow-up (after 8 months).

Laboratory analyses include the following:

* hematological parameters;
* semen quality parameters;
* prostate-specific antigen (PSA) in blood and semen;
* RedOx status parameters in semen;
* epigenetic analyses (DNA methylation) in blood lymphocytes and spermatozoa;
* content of heavy metals in blood and semen. The project has been approved by the local Ethics Committees. Differences of means and proportions of all variables between the intervention and control group and the associations between diet, physical activity and sperm and blood parameters will be assessed using common statistical tests for comparisons of means and proportions as a first step.

Conditions

• Fertility Disorders

Interventions

BEHAVIORAL

lifestyle counseling

Nutritional plan and Physical activity goals

Sponsors & Collaborators

• Istituto clinico Città di Brescia

  collaborator UNKNOWN

• Università degli Studi di Brescia

  collaborator OTHER

• Istituto Superiore di Sanità

  collaborator OTHER

• Ministero della Salute, Italy

  collaborator OTHER

• ISA-CNR, Avellino

  collaborator UNKNOWN

• Molecular Epidemiology and Environmental Epigenetics Lab

  collaborator UNKNOWN

• Azienda Sanitaria Locale Salerno

  lead OTHER

Principal Investigators

• Luigi Montano, Dr · Urology Unit, "S. Francesco d'Assisi" Hospital, Oliveto Citra, A.S.L. Salerno

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

22 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-05-02

Primary Completion

2018-12-31

Completion

2019-11-06

Countries

• Italy

Study Locations