💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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)
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