NCT06252922 Diet-Induced Changes in GEnetic Material
| NCT ID | NCT06252922 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pennington Biomedical Research Center |
| Condition | Diet, Healthy |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-11-11 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2023-11-11 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06252922 clinical trial?
This trial is open to male participants only, aged 20 Years or older, up to 35 Years, studying Diet, Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06252922 currently recruiting?
Yes, NCT06252922 is actively recruiting participants. Contact the research team at Emily.Flanagan@pbrc.edu for enrollment information.
Where is the NCT06252922 trial being conducted?
This trial is being conducted at Baton Rouge, United States.
Who is sponsoring the NCT06252922 clinical trial?
NCT06252922 is sponsored by Pennington Biomedical Research Center. The trial plans to enroll 10 participants.