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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

Official record on ClinicalTrials.gov — NCT06252922

Locations in the U.S.

LouisianaPennington 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.