Diet-Induced Changes in GEnetic Material

Launched by PENNINGTON BIOMEDICAL RESEARCH CENTER · Feb 1, 2024

Keywords

ClinConnect Summary

This clinical trial is examining how a high-fat diet might affect the genetic material in men, specifically looking at changes in DNA that could relate to obesity and heart health. The study aims to understand if changes in metabolism during this diet can influence the way genes in sperm are modified, which could have implications for future health.

To participate, men aged 20 to 35 who are healthy and have a normal body weight (BMI between 18.5 and 24.9) may be eligible. Participants will need to stay overnight at the research clinic and will be asked to follow a specific meal plan, wear devices to monitor their activity and glucose levels, and provide blood and sperm samples. It’s important for potential participants to be aware that they should not have any significant weight changes recently, must avoid certain health conditions, and should not be following restrictive diets. This study will help researchers learn more about the relationship between diet and genetic changes, which could lead to better health strategies in the future.

Gender

MALE

Eligibility 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)