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Diet-Induced Changes in GEnetic Material
RecruitingObservational studyHealthy volunteers welcome
A Pilot Study to Examine Metabolic Flexibility as a Mechanism for Diet- Induced Epigenetic Alterations in Male Gametes
Who can join
Ages 20 to 35 · Men · Healthy volunteers welcome
Full 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)
About the study
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.
Sponsor: Pennington Biomedical Research Center · Participants: 10 · Started: Nov 11, 2023
Contact the study team
- Emily Flanagan, PhD · Phone: (225) 763-2828
Official record on ClinicalTrials.gov — NCT06252922
Locations in the U.S.
| Louisiana | Pennington Biomedical Research Center, Baton Rouge |
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.