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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05034380
Other study ID # AcuteExerciseNucleo
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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