Project 1: Diet and Exercise Modulate the Sperm Epigenome in Men (NCT04175678) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Project 1: Diet and Exercise Modulate the Sperm Epigenome in Men
United States100 participantsStarted 2020-02-21
Plain-language 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.
Who can participate
Age range18 Years ā 40 Years
SexMALE
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Inclusion criteria
ā. Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine within the reference range at the time of screening
ā. Must have Hispanic Father and Mother from Mexico or Central America
ā. Normal weight, active subjects:
ā. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form
Exclusion criteria
ā. Men who meet any of the following criteria are NOT eligible for enrollment in the trial:
ā. Men participating in another clinical trial within the last 30 days prior to the first screening visit
ā. Men not living in the catchment's area of the clinic or within a reasonable distance from the site
ā. Clinically significant abnormal findings at screening except for those stated above for the obese, inactive group
ā
What they're measuring
1
Changes in the sperm epigenome
Timeframe: 5 years
Trial details
NCT IDNCT04175678
SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
. Abnormal serum chemistry values, according to local laboratory normal values that indicate chronic liver or kidney dysfunction or that may be considered clinically significant (except for obesity related abnormal laboratory tests including blood glucose, Hgb A1c, liver transaminases, lipids for the obese, active group as stated above). Other abnormal lab values may also be exclusionary, at the discretion of the investigator
ā. Sperm concentration below 15 million/mL in more than one of three screening samples
ā. Diastolic (D) blood pressure (BP) \> 30 and Systolic (S) BP \> 130 mm Hg for the healthy, non-obese and active group; and diastolic (D) blood pressure (BP) \> 150 and Systolic (S) BP \> 100 mm Hg for the obese, inactive group on in the opinion of the investigator not suitable for exercise training (BP will be taken 3 times at 5 minute intervals and the mean of all measurements be considered)
ā. History of hypertension, including hypertension controlled with treatment in the healthy, active group