Effects of diet on sperm DNA changes in men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.