Project 1: Diet and Exercise Modulate the Sperm Epigenome in Men

Obese Clinical Trial

Official title: Project 1: Diet and Exercise Modulate the Sperm Epigenome in Men

Status Recruiting

Clinical Trial Summary

This is a rigorous, controlled clinical trial designed to show that diet, exercise training, and their combination in overweight, inactive men will alter epigenetic programming to create a "healthy" sperm epigenome. Our central hypotheses are: i) overweight and inactive lifestyle results in epimutations in the sperm epigenome relative to the normal epigenetic programming in lean and active men and ii) diet and exercise modulation leads to reversal of these epimutations resulting in both a healthier "phenotype" and "epigenotype" which may persist after stopping the interventions. The study is divided into three parts:

1. We will recruit 20 healthy, active men and 20 obese and inactive Hispanic men between 18 and 40 years to determine the differences in sperm epigenome (DNA methylation, histone modifications and non-coding RNAs) in a cross-sectional study in obese inactive vs. healthy active Hispanic men. Only Hispanic men will be studied because of the high prevalence of obesity and inactivity in Hispanic younger men and to reduce the genetic variability influencing the epigenome.

2. 80 obese and inactive men will be randomized to 4 groups of 20 men: 1) No intervention (control); 2) Low fat, low caloric diet; 3) Supervised, periodized endurance and resistance training without modification of diet; and 4) Both exercise and diet modification to characterize the plasticity of the sperm epigenome in response to 12-week diet and/or exercise training interventions in obese and inactive Hispanic men. Sperm epimutations will be compared before and after intervention within each group and between groups.

3. The sperm epigenome studies in 80 men randomized to no intervention or diet and/or exercise training will be repeated at 12 and 36 weeks after cessation of interventions to Identify the persistent effects of diet and exercise training on the sperm epigenome after stopping the interventions.

Clinical Trial Description

This is not a clinical trial of a drug or device. This study will recruit 20 normal weight, physically active men and 80 obese, physically inactive Hispanic men aged between 18 and 40 years. The normal weight, active men will be studied at baseline only, whereas the obese, inactive men will be randomized and studied at baseline, after 12 weeks of diet modulation or exercise training. During the intervention period the participant will come to the study site at weeks 2, 4, 8, and 12. These men will be reassessed at 24 and 48 weeks (12 and 24 weeks) after cessation of intervention.

All research participants will be screened by medical history, physical examination, safety laboratory tests and depending on the BMI be eligible for the non-obesity or obese group. They will be provided with an accelerometer and nutritional survey and will return on day -14. If they meet the eligibility criteria then the non-obese, active men will be come for tests on day 1 and not further visits are required. The obese, inactive men and if they meet the criteria of that group they will be randomized to 1). No intervention; 2). Low fat and low caloric diet, 3). Exercise training; and 4) both diet modulation and exercise training for 12 weeks. Then they will be followed at 24 week and 48 weeks after start of treatment ;

Related Conditions & MeSH terms

• Healthy Lifestyle
• Men
• Obese

• NCT number: NCT04175678
• Study type: Interventional
• Source: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Contact: Christina Wang, MD
• Phone: 310-222-2503
• Email: wang@lundquist.org
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2020
• Completion date: March 3, 2025