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

NCT04012385 | Completed

• 1 other identifier: J59D1600132001
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 4

Brief 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:

• 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

Keywords

Lifestyle; Fertility; Nutrition; Environmental Pollution

Outcome Measures

Primary Outcomes (2)

• changes in spermatozoa motility

  % total motility of spermatozoa

  assessed at baseline, after 4 and 8 months

• changes in Total Antioxidant Capacity (TAC)

  Total Antioxidant Capacity, measured in semen samples (mM)

  assessed at baseline, after 4 and 8 months

Secondary Outcomes (4)

• Sperm count

  assessed at baseline, after 4 and 8 months from the enrollment

• PSA

  assessed at baseline and after 4 months from the enrollment

• epigenetic analyses

  assessed at baseline and after 4 months from the enrollment

• Trace elements

  assessed at baseline and after 4 months from the enrollment

Study Arms (2)

Control

NO INTERVENTION

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) .

Intervention

EXPERIMENTAL

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).

Behavioral: lifestyle counseling

Interventions

lifestyle counseling BEHAVIORAL

Nutritional plan and Physical activity goals

Intervention

Eligibility Criteria

• Age: 18 Years - 22 Years
• Gender Eligibility Details: 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
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Young healthy men aged 18-22 years, who have been living at least for 5 years in one of the recruitment areas (Lombardy Region, "Land of fires" or Valley of the Sacco river)
• Normal weight (18,5 ≤ Body Mass Index \< 25)
• Waist circumference \< 102cm
• Having a normal sperm count (not azoospermic or cryptospermic)
• Drinking less than 5 alcohol units a week (1AU=125ml)
• Smoking less than 5 cigarettes (including e-cigarette, cigar, pipe)
• Smoking marijuana less than 3 times a month
• Must not have undergone urogenital surgery.
• Must not have suffered cancer disease and/or undergone chemo/radiotherapy.

You may not qualify if:

• Smoking more than 5 cigarettes a week
• Smoking marijuana more than 3 times a month
• Using drugs (other than marijuana)
• Drinking more than 5 alcohol units a week (1AU=125ml)
• Using dietary supplements (any type)
• Having a prior urogenital surgery (for varicocele: up to 12 months before the enrollment)
• Having suffered cancer and/or undergone chemo/radiotherapy
• Using anti-inflammatory drug on a regular basis (such as cortisone and/or NSAIDs) and/or having taken one of those drugs up to 72 hours before the collection of blood and semen samples.
• Using phosphodiesterase type 5 inhibitors (PDE5 inhibitor) up to 72 hours before the collection of blood and semen samples.
• Using steroids and/or anabolic hormones.
• Using dietary supplements and/or substances containing vegetal/animal extracts and/or trace elements up to 6 months before the enrollment.
• Fever status and/or antibiotic therapy up to 2 weeks before the enrollment.

Sponsors & Collaborators

• Azienda Sanitaria Locale Salerno: lead
• Istituto clinico Città di Brescia: collaborator
• Università degli Studi di Brescia: collaborator
• Istituto Superiore di Sanità: collaborator
• Ministero della Salute, Italy: collaborator
• ISA-CNR, Avellino: collaborator
• Molecular Epidemiology and Environmental Epigenetics Lab: collaborator

Study Sites (4)

Urology Unit "S. Francesco d'Assisi" Hospital

Oliveto Citra, Salerno, 84020, Italy

Location

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

Brescia, 25123, Italy

Location

Unit of Urology - Istituto Clinico Città di Brescia

Brescia, 25128, Italy

Location

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

Roma, 00161, Italy

Location

Related Publications (22)

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Related Links

• project website

Study Officials

• Luigi Montano, Dr

  Urology Unit, "S. Francesco d'Assisi" Hospital, Oliveto Citra, A.S.L. Salerno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A specific alphanumeric code is assigned to each participant
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: July 9, 2019
• Study Start: May 2, 2018
• Primary Completion: December 31, 2018
• Study Completion: November 6, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

IT (4)