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Completed

NCT Number: NCT05034380

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

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.

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Key information

Conditions

Obesity Acute Exercise Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute exercise

Behavioral

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.

Primary outcomes

  1. Change from baseline in skeletal muscle acylcarnitines

    Time frame: Baseline and immediately after acute cycling exercise

    Metabolomics of skeletal muscle acylcarnitines is used as a measure of mitochondrial function by assessing long, medium and short chain acylcarnitine levels.

  2. Change from baseline in skeletal transcriptome

    Time frame: Baseline and immediately after acute cycling exercise

    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.

  3. Change from baseline in skeletal muscle whole genome nucleosome maps

    Time frame: Baseline and immediately after acute cycling exercise

    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.

Secondary outcomes

  1. Glucose

    Time frame: Baseline and immediately after acute cycling exercise

    Commercially validated and available colorimetric used to determine plasma glucose levels.

  2. Insulin

    Time frame: Baseline and immediately after acute cycling exercise

    Commercially validated and available ELISAs used to determine plasma insulin levels.

  3. Triglycerides

    Time frame: Baseline and immediately after acute cycling exercise

    Commercially validated and available colorimetric kits used to determine plasma triglyceride levels.

  4. Free fatty acids

    Time frame: Baseline and immediately after acute cycling exercise

    Commercially validated and available colorimetric kits used to determine plasma free fatty acid levels.

  5. Cholesterol

    Time frame: Baseline and immediately after acute cycling exercise

    Commercially validated and available colorimetric kits used to determine total cholesterol, HDL, LDL and VLDL levels in plasma.

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Collaborators

  • Louisiana State University Health Sciences Center Shreveport
  • Purdue University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Sep 5, 2021
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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