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Diet-Induced Changes in GEnetic Material

Pennington Biomedical Research Center · NCT06252922

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 20–35 · Men only
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
10
US sites recruiting
1
Study start
November 11, 2023
Record last updated
May 31, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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: Diet, Healthy; Body Weight; Metabolic Disturbance

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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)

Recruiting US locations

  • Pennington Biomedical Research Center

    Baton Rouge, LA 70808

    Site contact: Emily Flanagan, PhD · 225-763-2828 · Emily.Flanagan@pbrc.edu

Study contacts (from the official record)

  • Emily Flanagan, PhD · (225) 763-2828 · Emily.Flanagan@pbrc.edu
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Diet-Induced Changes in GEnetic Material (NCT06252922) | Bored Studies