Diet-Induced Changes in GEnetic Material
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age20-35
SponsorPennington Biomedical Research Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male based on biological sex
Age 20-35 years
BMI between 18.5 and 24.9 kg/m2
White/Caucasian
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Sperm DNA methylation
Incidence of DNA methylation (whole genome/epigenome wide) of genes in sperm measured using bisulphate sequencing
Time frame
Baseline, Immediately after the healthy diet, Immediately after the high-fat dietSecondary outcomes
1
Sperm DNA Damage
Comet Assay to determine DNA fragmentation in sperm.
Time frame
Baseline, Immediately after the healthy diet, Immediately after the high-fat dietOther outcomes
1
Metabolic Flexibility (indirect)
Change in respiratory quotient (RQ) from a fasted to a fed state using a metabolic chamber.
Time frame
Immediately after the healthy diet, Immediately after the high-fat diet2
Metabolic Flexibility (direct)
Changes to circulating glucose from a fasted (0 minutes) to a fed state (240 minutes).
Time frame
Immediately after the healthy diet, Immediately after the high-fat diet3
Continuous glucose monitoring
Mean Amplitude of Glycemic Excursions (MAGE) in response to healthy and high fat diets.
Time frame
Immediately after the healthy diet, Immediately after the high-fat diet4
Insulin sensitivity
Mean 24hr glucose and total 24hr c-peptide excretion
Time frame
Immediately after the healthy diet, Immediately after the high-fat dietSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov