Recruiting

Genetic Material

Sponsor:

Pennington Biomedical Research Center

Code:

NCT06252922

Conditions

Diet, Healthy

Body Weight

Metabolic Disturbance

Eligibility Criteria

Sex: Male

Age: 20 - 35

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Diet, Healthy

Body Weight

Metabolic Disturbance

Study ID

NCT06252922

Start date

Nov 11, 2023

Status verified date

May, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 20 - 35

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Sperm DNA methylation [ Time Frame: Baseline, Immediately after the healthy diet, Immediately after the high-fat diet ]

Central Contacts and Locations

Central contacts

Emily Flanagan, PhD

(225) 763-2828Emily.Flanagan@pbrc.edu

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Emily Flanagan, PhD

225-763-2828Emily.Flanagan@pbrc.edu

Principal Investigator:

Emily Flanagan, PhD

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

May 31, 2025

Last verified

May, 2025

Keywords

  • Healthy Weight
  • High-Fat Diet
  • Sperm DNA Methylation
  • Metabolic Flexibility
  • DNA Damage
  • Substrate Flux
  • Preconception

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2025-05-31.