Participants will be provided with control chicken-meat and control eggs, and will be requested to eat at least three portions/week of the control chicken-meat, and to eat at least three control eggs/week, for 6 months.

Participants will be provided with control chicken-meat and omega-3-PUFA enriched eggs, and will be requested to eat at least three portions/week of the control chicken-meat, and to eat at least three omega-3-enriched eggs/week, for 6 months.

Participants will be provided with omega-3-PUFA enriched chicken-meat and control eggs, and will be requested to eat at least three portions/week of the omega-3-PUFA enriched chicken-meat, and to eat at least three control eggs/week, for 6 months.

Participants will be provided with omega-3-PUFA enriched chicken-meat and omega-3-PUFA enriched eggs, and will be requested to eat at least three portions/week of the omega-3-PUFA enriched chicken-meat, and to eat at least three omega-3-PUFA enriched eggs/week, for 6 months.

Healthy Diet

Control Chicken-meat

Control Eggs

Omega-3-PUFA Enriched Chicken-meat

Omega-3PUFA Enriched Eggs

Royal College of Surgeons at Beaumont Hospital

Impacts of Omega-3-PUFA Enriched Chicken-meat and Eggs in Healthy Humans

A Study of the Absorption, Distribution and Cardiovascular Benefits for Humans of Eating Chicken-meat and Eggs Enriched With Omega-3 PUFAs Over a 6-month Period

Sum of EPA and DHA expressed as percentage of total fatty acids in erythrocyte membranes

Sum of plasma levels of EPA and DHA (microgram/gram)

Mean 24-hour ambulatory systolic blood pressure (mmHg)

Mean 24-hour ambulatory diastolic blood pressure (mmHg)

Mean 24-hour ambulatory heart rate (beats/minute)

High-sensitivity C-reactive protein (mg/L)

Urinary thromboxane/creatinine ratio (pg/mg creatinine)

(Z Verbal Fluency (Letter Fluency) + Z Verbal Fluency (Category Fluency) + Z Verbal Fluency (Switching Fluency) - Z Trail Making Test (Number Letter Switching - [(Number Sequencing + Letter Sequencing)/2]) -Z Colour Word Interference (Inhibition - [(Colour Naming + Word Reading)/2]) - Z Colour Word Interference (Inhibition Switching - [(Colour Naming + Word Reading)/2]))/ 6

(Z Word List (Immediate Recall) + Z Word List (Delayed Recall) + Z Word List (Recognition) + Z Logical Memory (Immediate Recall) + Z Logical Memory (Delayed Recall) + Z Logical Memory (Recognition) ) /6

(Z Complex Figure (Immediate Recall) + Z Complex Figure (Delayed Recall))/2

(Z Trail Making Test (Visual Scanning) + Z Trail Making Test (Number Sequencing) + Z Trail Making Test (Letter Sequencing) + Z Colour Word Interference (Colour naming) + Z Colour Word Interference (Word Reading)) /5) * - 1

(Z Finger Tapping (Dominant Hand) + Z Finger Tapping (Non-Dominant Hand)) /2

All de-identified individual participant data that underlie the results in a publication, and applicable supporting clinical trial documents, may be available upon request.

Alice Stanton

Professor of Cardiovascular Therapeutics

Devenish Nutrition, Belfast, United Kingdom.

Beaumont Hospital

University College Dublin

This will be a controlled, double-blind randomized study. Using a 2X2 factorial design, 160 participants will be randomized to eat at least three portions/week of omega-3-PUFA enriched (or control) chicken-meat, and to eat at least three omega-3-PUFA enriched (or control) eggs/week, for 6 months.
Numbers in each treatment group are indicated below; Control chicken-meat & Control Eggs (n=40) Control chicken-meat & Omega-3 PUFA enriched Eggs (n=40) Omega-3 PUFA enriched chicken-meat & Control Eggs (n=40) Omega-3 PUFA enriched chicken-meat & Omega-3 PUFA enriched Eggs (n=40)

Randomisation and masking The randomisation schedule was computer generated. Separate sealed opaque envelopes were prepared for male and female participants. All investigators involved in participant recruitment, data collection and entry, sample collection, processing and analysis, will be masked to the randomisation groups until data entry is completed and the database is locked.

Subjects assigned to control group receives only a booklet including the recommendations for a correct diet by the Italian National Institute for Research on Food and Nutrition (INRAN), presently called (CRA-NUT) .

Subjects assigned to the intervention group will follow a nutritional pathway based on a Mediterranean diet pattern for 4 months and receive suggestions on the regular practice of physical activity, under the guide of some nutritionists, who will propose individualized diets for each subject.
All subjects of both groups will undergo urologic examination, measurement of weight, height and abdominal circumference, an interview on demographic data and lifestyle variables, 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).

Fertility Disorders

Gender-based eligibility is directly related to the main purpose of the study, that is to evaluate the effects of lifestyle changes on male germ cells

Nutritional plan and Physical activity goals

lifestyle counseling

Urology Unit "S. Francesco d'Assisi" Hospital

Unit of Hygiene, Epidemiology and Public Health, University of Brescia

Unit of Urology - Istituto Clinico Città di Brescia

Dpt. of Food safety, nutrition and veterinary public health, Italian National Institute of Health (ISS)

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

An Intervention Model for the Prevention of Infertility in Healthy Young Men Living in Highly Polluted Areas

Total Antioxidant Capacity, measured in semen samples (mM)

Prostate-Specific Antigen in seminal plasma and in blood serum, measured in ng/ml

DNA-methylation status of Alu and L1 sequences

dosage of trace elements in seminal plasma, semen and blood serum

LUIGI MONTANO

Principal Investigator

Azienda Sanitaria Locale Salerno

Istituto clinico Città di Brescia

Università degli Studi di Brescia

Istituto Superiore di Sanità

Ministero della Salute, Italy

ISA-CNR, Avellino

Molecular Epidemiology and Environmental Epigenetics Lab

Primary purpose of the study is the improvement of semen quality in healthy young men living in highly polluted areas, operating on two specific lifestyle factors, that are nutrition and physical activity. Overall, 450 subjects will be enrolled (150 for single recruiting area) and they will be assigned by chance to one of the two arms of the study, named "Control group" and "Intervention group". Every subject is identified by means of an individual alphanumeric code that does not specifies which group they belong to, in order to mask to all the outcomes assessors the membership to one arm or another.

A specific alphanumeric code is assigned to each participant

Participants will eat fatty fish and avoiding nuts)

Participants who will avoid both fatty fish and nuts

Obesity

Metabolic Syndrome

Diabetes

At inclusion demographic information recorded, including length of breastfeeding for women. Thereafter, participants will start with a run-in period of two weeks where they will be asked not to consume salmon, mackerel, sardines or other fatty fish or nuts providing a dietary baseline. At baseline, subjects will be randomized to a fish, nuts or control group. The fish group will be asked to consume three to four portions weekly. The fish will be eaten at the main meal and in sandwiches for a total of 600 grams weekly for 6 months. This group will avoid eating nuts. The nut group will consume equal amount of energy (~1400 kcal ) for weekly use for 6 months. This group will avoid eating fatty fish. The control group will consume their usual diet, but asked to avoid fatty fish and nuts.

The fatty fish group

At baseline (conditions for baseline are the same in all three groups) the nut group will consume equal amount of energy (~1400 kcal ~100 grams walnuts, ~50 grams hazelnuts and ~50 grams almonds/week).The nuts will be provided free of charge for the six months. This group will avoid eating fatty fish.

The nut group

After the baseline the control group will consume their usual diet, asked to avoid fatty fish and nuts.

The control group

Oslo University Hospital, Ullevål

Fish or Nuts? Dietary Effects on Cardiometabolic Risk Factors and Persistent Organic Pollutants

Measuring of persistent organic pollutants' levels before and after intervention.
Blood tests will be obtained at randomization, and six months of follow-up for analysis analysis of environmental pollutants including 21 POPs in g/mol .Six-month follow-up samples will be stored for future analyses.

waist circumference in cm as cardiometabolic risk factor

Secondary endpoints will include C-reactive protein

The HOMA index (The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function) in % will be calculated

HDL-C (high-density lipoprotein) in mmol/L

Sasa Dusanov

PhD candidate

Oslo University Hospital

Any current participant of the World Trade Center Health Program-Clinical Center of Excellence, formerly known as World Trade Center Medical Monitoring and Treatment Program

Pulmonary Disease

Cardiac Disease

Cardiopulmonary Disease

Obstructive Sleep Apnea

Cardiovascular Disease

Icahn School of Medicine at Mount Sinai

World Trade Center (WTC) CHEST

Pulmonary Abnormalities, Diastolic Dysfunction, and World Trade Center Exposure: Implications for Diagnosis and Treatment

To evaluate the persistent longitudinal effects of pulmonary function abnormalities (spirometry) and additionally demonstrate prevalence of impaired DLCO in WTC responders.

To determine the relationship between pulmonary function abnormalities (spirometry and DLCO) and cardiac dysfunction using echocardiograms to measure right ventricular (RV) diastolic dysfunction.

To evaluate the association between levels of exposure to inhaled particulate matter on cardiac dysfunction as measured by left ventricular (LV) diastolic function or evidence of subclinical atherosclerosis with high risk coronary calcium scores in WTC responders.

To determine the risks of developing obstructive sleep apnea (OSA) in the WTC responder population, and to evaluate the effect of OSA on mediating diastolic dysfunction.

To demonstrate specific mediators and pathways that link effects of inhaled particulate matter to microvascular and cardiovascular disease. This objective will be explored using measurements of vascular reactivity (peripheral arterial tonometry) and serum inflammatory and hemostatic markers from blood stored at the initial monitoring visit, as well as current blood samples.

biphenyl/bólga

Impacts of Omega-3-PUFA Enriched Chicken-meat and Eggs in Healthy Humans

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

Fish or Nuts? Dietary Effects on Cardiometabolic Risk Factors and Persistent Organic Pollutants

World Trade Center (WTC) CHEST

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