Actively Recruiting

Age: 20Years - 35Years
MALE
Healthy Volunteers
NCT06252922

Diet-Induced Changes in GEnetic Material

Led by Pennington Biomedical Research Center · Updated on 2025-05-31

10

Participants Needed

1

Research Sites

163 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Diet-Induced Changes in GEnetic Material

Who Can Participate

Age: 20Years - 35Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male based on biological sex
  • Age 20 to 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
  • 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
Not Eligible

You will not qualify if you...

  • Unstable weight in the last 3 months (±15% 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)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

Actively Recruiting

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Research Team

E

Emily Flanagan, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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