Effects of diet on sperm DNA changes in men
A Pilot Study to Examine Metabolic Flexibility as a Mechanism for Diet- Induced Epigenetic Alterations in Male Gametes
This study tests how eating a high-fat diet affects the DNA in sperm of healthy men aged 20-35 to see if it relates to obesity and metabolic health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | Male |
| Sponsor | Pennington Biomedical Research Center Academic / other |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT06252922 on ClinicalTrials.gov |
What this trial studies
This observational pilot study investigates how a high-fat diet influences DNA methylation in sperm among healthy men aged 20-35. The study aims to understand the relationship between dietary changes, metabolic flexibility, and inflammatory responses, and how these factors affect genetic material associated with obesity and metabolic diseases. Participants will consume pre-prepared meals and undergo monitoring of their diet and metabolic responses while providing blood and sperm samples for analysis.
Who should consider this trial
Good fit: Ideal candidates are healthy Caucasian males aged 20-35 with a BMI between 18.5 and 24.9.
Not a fit: Patients with unstable weight, chronic diseases, or those who smoke or have a history of diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how paternal diet impacts offspring health and metabolic disease risk.
How similar studies have performed: While there is limited experimental research on this specific topic, observational studies suggest that diet significantly affects sperm quality and DNA methylation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male based on biological sex * Age 20-35 years * BMI between 18.5 and 24.9 kg/m2 * White/Caucasian * Willing to consume pre-prepared meals * Willing to wear an accelerometer and continuous glucose monitor (CGM) * Willing to track diet intake * Willing to stay 24 hours, including overnight in a research clinic * Willing to provide blood and sperm samples * Willing to consent to whole-genome sequencing of DNA Exclusion Criteria: * Unstable weight in the last 3 months (±5% weight loss or gain) * Shift work or working in a factory setting * Habitual smoking or use of tobacco products, including vaping, within the past 6 months. * History of clinically diagnosed diabetes * Hypertension (\>140/90 mmHg measured at screening) * Has undergone bariatric surgery * History of cardiovascular disease, neurological disease, or other chronic diseases, including cancer * History of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) * Adherence to special or restrained diets (e.g., low-CHO, low-fat, or vegetarian/vegan diets) or food allergies associated with study foods. * Currently engaging in \>150 minutes moderate-intensity or \>75 minutes of vigorous-intensity physical activity each week * Drinking more than 14 servings of beer or alcohol per week * Depressive (Score ≥10), anxiety (Score ≥8), and stress (Score≥15) symptomology (Score ≥16) from the 42-item Depression, Anxiety, Stress Scales (DASS)
Where this trial is running
Baton Rouge, Louisiana
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (Recruiting)
Study contacts
- Study coordinator: Emily Flanagan, PhD
- Email: Emily.Flanagan@pbrc.edu
- Phone: (225) 763-2828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.