Actively Recruiting
A Pilot Study to Examine Metabolic Flexibility as a Mechanism for Diet-Induced Epigenetic Alterations in Male Gametes
Led by Pennington Biomedical Research Center · Updated on 2025-05-31
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how a high-fat diet affects DNA methylation in the sperm of healthy men aged 20 to 35. This study explores the Paternal Origins of Health and Disease hypothesis, which suggests that a father's diet can influence the genetic markers related to obesity and metabolic diseases in his offspring. Observational studies have linked high-fat and processed food diets to reduced sperm quality and changes in DNA methylation, but this study will experimentally test these effects. The study involves 10 healthy male participants who will follow two diet plans: a healthy diet (27% fat, 55% carbohydrate, 15% protein) followed by a high-fat diet (50% fat, 35% carbohydrate, 15% protein). Researchers will observe how these diets impact metabolic flexibility and the metabolic and inflammatory environment, and how these changes relate to DNA methylation in sperm. Participants will consume pre-prepared meals and undergo monitoring during each diet phase. Participants will stay for 24 hours, including overnight, in a research clinic while wearing an accelerometer and continuous glucose monitor. Blood and sperm samples will be collected at baseline and immediately following each diet phase to measure sperm DNA methylation and DNA damage. The study aims to understand diet-induced epigenetic changes in male gametes, with careful monitoring of metabolic and inflammatory responses over the study period.
CONDITIONS
Brief Title
Diet-Induced Changes in GEnetic Material
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male based on biological sex
- Age 20 to 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
- 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
You will not qualify if you...
- 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 (over 140/90 mmHg measured at screening)
- Has undergone bariatric surgery
- History of cardiovascular disease, neurological disease, or other chronic diseases, including cancer
- History of HIV or AIDS
- Adherence to special or restrained diets (e.g., low-carb, low-fat, vegetarian/vegan) or food allergies related to study foods
- Currently engaging in over 150 minutes moderate-intensity or over 75 minutes vigorous-intensity physical activity each week
- Drinking more than 14 servings of beer or alcohol per week
- Depressive, anxiety, or stress symptoms above specified thresholds on the 42-item Depression, Anxiety, Stress Scales (DASS)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 2 to 3 weeks
Participants follow two diets sequentially, a healthy diet followed by a high-fat diet, to study their effects on sperm DNA methylation and metabolic markers.
1 baseline visit and 2 diet intervention visits (in-person)
Trial Site Locations
Total: 1 location
1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
Research Team
E
Emily Flanagan, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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