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

Running, not enrolling · Not applicable

Conditions studied: Healthy Lifestyle, Obese, Men

In brief

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.

Key facts

Study ID: NCT04175678
Run by: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
People needed: 100
Starts: 2020-02-21
Expected to finish: 2026-06-30
Last updated by the study team: 2026-03-10

Who can join

Age: 18 and older, up to 40. Sex: male. Healthy volunteers: accepted.

You may qualify if…

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
Must have Hispanic Father and Mother from Mexico or Central America
Normal weight, active subjects:
BMI 18.5 - 24.9 calculated as weight in Kg/ (height in cm)2
Participates in ≥150 min/week of moderate intensity physical activity as assessed by accelerometer
Consume < 30% of calories as fat/day
Fasting lipid panel within reference range or not clinically significant above the reference ranges
Obese and physically inactive subjects:
BMI ≥ 30 calculated as weight in Kg/ (height in cm)2 in obese subjects
Have risk factors for developing type 2 diabetes (first degree relatives with Diabetes Mellitus type 2, BP≥130/80, HDL-cholesterol ≤ 35mg/dL or triglycerides ≥200mg/dL, fasting plasma glucose ≥100mg/dl to 125mg/dL or HgbA1c ≥ 5.7 to 6.4%, abnormal liver transaminases (not more than 3 times upper limit of normal suggestive of hepatic steatosis)
Participates in ≤150 min/week of moderate intensity physical activity
Consume >30 % fat as calories/day
Stable weight for past six months prior to the first screening visit
Willing to commit to 12 weeks of three times a week personalized exercise training
Willing to commit to 12 weeks of weight loss diet (low fat and low calories)
In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form
Does not meet any of the exclusion criteria.

You may not qualify if…

Men who meet any of the following criteria are NOT eligible for enrollment in the trial:
Men participating in another clinical trial within the last 30 days prior to the first screening visit
Men not living in the catchment's area of the clinic or within a reasonable distance from the site
Clinically significant abnormal findings at screening except for those stated above for the obese, inactive group
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
Sperm concentration below 15 million/mL in more than one of three screening samples
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)
History of hypertension, including hypertension controlled with treatment in the healthy, active group
Known history of reproductive dysfunction including vasectomy or infertility
Known history of cardiac, renal, hepatic, cardiac or respiratory disease
A serious systemic disease such as diabetes mellitus defined by the American Diabetes Association or morbid obesity (body weight greater than 120% of ideal body weight or BMI limitation as above)
Known or suspected alcoholism or drug abuse or chronic infections
Serious digestive and/or absorptive problems, including inflammatory bowel disease and
Chronic food intolerance or diarrhea that preclude adherence to the study diet.
Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity.
Psychiatric disorders (including eating disorders) or conditions that, in the opinion of the investigator, would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder).
History of other malignancies except: adequately treated non-melanoma skin cancer

Where it is running

The Lundquist Institute — Torrance, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.