NCT06252922 · Pennington Biomedical Research Center
Diet-Induced Changes in GEnetic Material
(DIG 'EM)
What this study is about
This is a pilot study in 10 men to test the hypothesis that perturbations in substrate flux and the circulating metabolic and pro-inflammatory milieus during a high-fat diet paradigm will modulate DNA methylation of genes in sperm associated with obesity and cardiometabolic dysfunction.
View original scientific description
This is a pilot study in 10 men to test the hypothesis that perturbations in substrate flux and the circulating metabolic and pro-inflammatory milieus during a high-fat diet paradigm will modulate DNA methylation of genes in sperm associated with obesity and cardiometabolic dysfunction.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Baton Rouge, Louisiana
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 31, 2025 · Source of record for eligibility and locations