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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05034380
• Other study ID #: AcuteExerciseNucleo
• Status: Completed
• Phase: N/A
• Start date: September 14, 2014
• Est. completion date: March 14, 2016

Study information

• Verified date: August 2021
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 14, 2016
• Est. primary completion date: October 6, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Exercise
• Cardiovascular Diseases
• Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• Acute exercise
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.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
East Carolina University	Louisiana State University Health Sciences Center Shreveport, Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Glucose	Commercially validated and available colorimetric used to determine plasma glucose levels.	Baseline and immediately after acute cycling exercise
Secondary	Insulin	Commercially validated and available ELISAs used to determine plasma insulin levels.	Baseline and immediately after acute cycling exercise
Secondary	Triglycerides	Commercially validated and available colorimetric kits used to determine plasma triglyceride levels.	Baseline and immediately after acute cycling exercise
Secondary	Free fatty acids	Commercially validated and available colorimetric kits used to determine plasma free fatty acid levels.	Baseline and immediately after acute cycling exercise
Secondary	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