RecruitingNCT06252922

Diet-Induced Changes in GEnetic Material

A Pilot Study to Examine Metabolic Flexibility as a Mechanism for Diet- Induced Epigenetic Alterations in Male Gametes

Sponsor

Pennington Biomedical Research Center

Enrollment

10 participants

Start Date

Nov 11, 2023

Study Type

OBSERVATIONAL

Conditions

Metabolic Disturbance Diet, Healthy Body Weight

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

Sex: MALEMin Age: 20 YearsMax Age: 35 Years

Inclusion Criteria10

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 Criteria12

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)