Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome

Study Overview
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Brief Summary
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The purpose of this study is to determine the ability of acute exercise to regulate fat metabolism in muscle of overweight and obese people compared to lean people.

Detailed Description
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After being informed about the study details and possible risks and benefits, 15 overweight/obese and 15 lean participants gave written informed consent and were then screened and enrolled in the study. All participants then gave a muscle sample and ate a calorically controlled breakfast. Participants completed  1 hour of cycling exercise on a stationary bike and gave a second muscle sample 4 hours after eating breakfast.

Official Title
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Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome in Lean and Overweight or Obese Subjects

Conditions
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Obesity, Type 2 Diabetes, Cardiovascular Diseases, Acute Exercise

Intervention / Treatment
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* Behavioral: Acute exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy males that completed a physical examination with a State Licensed M.D. or D.O. within the past 2 years and completed a physical activity readiness questionnaire (PARQ), the International Physical Activity Questionnaires (IPAQ) and and a medical history questionnaire prior to the study Exclusion Criteria: any participants that had not had a physical examination by a State Licensed M.D. or D.O. within the past 2 years persons not considered healthy (with any previous medical diagnoses) or not medically cleared by a M.D. or D.O. to perform physical activity/exercise persons who are regularly physically active

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All participants underwent the same exact study protocol on random days throughout the study period.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lean<br>males aged 18-30 years with BMI < 25 | Behavioral: Acute exercise<br>* All participants consumed a standardized, high carbohydrate meal (7 kcal/kg; 60% carbohydrate, 25% fat, 15% protein) and completed an exercise testing trial, expending a total of 650 kcal upon completion 4h later.<br>|
| Experimental: Overweight/Obese<br>males aged 18-30 years with BMI >= 25 | Behavioral: Acute exercise<br>* All participants consumed a standardized, high carbohydrate meal (7 kcal/kg; 60% carbohydrate, 25% fat, 15% protein) and completed an exercise testing trial, expending a total of 650 kcal upon completion 4h later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in skeletal muscle acylcarnitines | Metabolomics of skeletal muscle acylcarnitines is used as a measure of mitochondrial function by assessing long, medium and short chain acylcarnitine levels. | Baseline and immediately after acute cycling exercise | 
| Change from baseline in skeletal transcriptome | RNA-seq is a method used to quantify changes in all known messenger RNA levels in the genome, giving an assessment of whole genome gene transcription changes. | Baseline and immediately after acute cycling exercise | 
| Change from baseline in skeletal muscle whole genome nucleosome maps | MNase-seq is a method used to determine the occupancy/location of nucleosomes throughout the entire genome, supporting evidence of alterations in epigenetic modifications occurring at specific genomic loci that affect nucleosome occupancy/location and possibly gene transcription or silencing. | Baseline and immediately after acute cycling exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | Commercially validated and available colorimetric used to determine plasma glucose levels. | Baseline and immediately after acute cycling exercise | 
| Insulin | Commercially validated and available ELISAs used to determine plasma insulin levels. | Baseline and immediately after acute cycling exercise | 
| Triglycerides | Commercially validated and available colorimetric kits used to determine plasma triglyceride levels. | Baseline and immediately after acute cycling exercise | 
| Free fatty acids | Commercially validated and available colorimetric kits used to determine plasma free fatty acid levels. | Baseline and immediately after acute cycling exercise | 
| Cholesterol | Commercially validated and available colorimetric kits used to determine total cholesterol, HDL, LDL and VLDL levels in plasma. | Baseline and immediately after acute cycling exercise |