Diet-Induced Changes in GEnetic Material

NCT06252922 | Recruiting

• 1 other identifier: PBRC 2023-043
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sperm DNA methylation

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

  Baseline, Immediately after the healthy diet, Immediately after the high-fat diet

Secondary Outcomes (1)

• Sperm DNA Damage

  Baseline, Immediately after the healthy diet, Immediately after the high-fat diet

Other Outcomes (4)

• Metabolic Flexibility (indirect)

  Immediately after the healthy diet, Immediately after the high-fat diet

• Metabolic Flexibility (direct)

  Immediately after the healthy diet, Immediately after the high-fat diet

• Continuous glucose monitoring

  Immediately after the healthy diet, Immediately after the high-fat diet

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study will enroll healthy men from the greater Baton Rouge area who meet the above eligibility criteria and are willing to participate in this research trial.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Related Links

• Official Study Landing Page

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Emily Flanagan, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: February 12, 2024
• Study Start: November 11, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)