Diet-Induced Changes in Genetic Material Study

This observational study is looking at how different diets affect the genetic material (DNA) in sperm. Researchers want to see if eating a healthy diet versus a high-fat diet changes the DNA in sperm that is linked to obesity and heart problems. They will measure these changes at the beginning of the study, after a healthy diet, and again after a high-fat diet. This study is for men aged 20-35 who are healthy and have a normal body weight. The goal is to understand how diet might impact the health of future generations. The study is currently unclear on its recruitment status and plans to enroll 10 participants.

Study design
This is an observational study with 10 participants. It is not specified if it is randomized or blinded.
What's involved
You would need to consume pre-prepared meals, wear an accelerometer and continuous glucose monitor, track your diet, and stay overnight in a research clinic for 24 hours. You would also provide blood and sperm samples.
Compensation
Not stated in the trial record.
Follow-up
Sperm DNA methylation will be measured at baseline, immediately after the healthy diet, and immediately after the high-fat diet.

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NCT06252922

Diet-Induced Changes in GEnetic Material

Recruiting
Not specifiedAges 20–35Observational
Pennington Biomedical Research Center
~10 participants
Updated 2025-05-31 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sperm DNA methylation
Measured over Baseline, Immediately after the healthy diet, Immediately after the high-fat diet
Diet, Healthy
Body Weight
Metabolic Disturbance
1 sites across 1 states
Louisiana1

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Eligibility criteria

Inclusion

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

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)
  • Sperm DNA methylationBaseline, Immediately after the healthy diet, Immediately after the high-fat diet

    Incidence of DNA methylation (whole genome/epigenome wide) of genes in sperm measured using bisulphate sequencing