- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05034380
Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome
August 28, 2021 updated by: Jessica Ellis, East Carolina University
Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome in Lean and Overweight or Obese Subjects
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Lean
males aged 18-30 years with BMI < 25
|
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.
|
|
Experimental: Overweight/Obese
males aged 18-30 years with BMI >= 25
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and immediately after acute cycling exercise
|
|
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.
|
Baseline and immediately after acute cycling exercise
|
|
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.
|
Baseline and immediately after acute cycling exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glucose
Time Frame: Baseline and immediately after acute cycling exercise
|
Commercially validated and available colorimetric used to determine plasma glucose levels.
|
Baseline and immediately after acute cycling exercise
|
|
Insulin
Time Frame: Baseline and immediately after acute cycling exercise
|
Commercially validated and available ELISAs used to determine plasma insulin levels.
|
Baseline and immediately after acute cycling exercise
|
|
Triglycerides
Time Frame: Baseline and immediately after acute cycling exercise
|
Commercially validated and available colorimetric kits used to determine plasma triglyceride levels.
|
Baseline and immediately after acute cycling exercise
|
|
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.
|
Baseline and immediately after acute cycling exercise
|
|
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.
|
Baseline and immediately after acute cycling exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tara Henagan, PhD, Purdue University, Louisiana State University Medical School at Shreveport
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2014
Primary Completion (Actual)
October 6, 2015
Study Completion (Actual)
March 14, 2016
Study Registration Dates
First Submitted
September 16, 2020
First Submitted That Met QC Criteria
August 28, 2021
First Posted (Actual)
September 5, 2021
Study Record Updates
Last Update Posted (Actual)
September 5, 2021
Last Update Submitted That Met QC Criteria
August 28, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AcuteExerciseNucleo
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Hull University Teaching Hospitals NHS TrustNot yet recruitingCardiovascular Surgery | Cardiovascular Diseases (CVD)United Kingdom
-
Weill Medical College of Cornell UniversityAmerican Heart AssociationRecruitingCardiovascular | Cardiovascular Health | Cardiovascular (CV) Risk | Cardiovascular Disease (CVD) Risk FactorsUnited States
-
Fu Jen Catholic UniversityRecruitingCardiovascular Disease | Cardiovascular SurgeryTaiwan
-
Medical College of WisconsinNational Center for Complementary and Integrative Health (NCCIH)CompletedCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
IRCCS Policlinico S. DonatoIRCCS San Raffaele; Fondazione Policlinico Universitario Agostino Gemelli IRCCS and other collaboratorsRecruitingCardiovascular Risk | Genetic Cardiovascular RiskItaly
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
Children's Hospital Medical Center, CincinnatiRecruitingCardiovascular Diseases (CVD)United States
Clinical Trials on Acute exercise
-
Instituto de Cardiologia do Rio Grande do SulCompleted
-
Pennington Biomedical Research CenterNutrition Obesity Research CenterCompleted
-
Milton S. Hershey Medical CenterTerminatedWomen In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology (WISER-WIN)Breast CancerUnited States
-
Turku University HospitalUnknownCardiac FunctionFinland
-
Dalarna UniversityKarolinska Institutet; Swedish Council for Working Life and Social Research; Dalarna... and other collaboratorsCompletedChronic Pain, Widespread | Chronic Musculoskeletal DiseaseSweden
-
Université Blaise Pascal, Clermont-FerrandUnknownPediatric Obesity
-
Hospital de Clinicas de Porto AlegreCompletedDiabetes Mellitus, Type 2 | Exercise | TreatmentBrazil
-
University of HoustonCompleted
-
Towson UniversityCompletedEndothelial Dysfunction | Arterial StiffnessUnited States
-
VA Office of Research and DevelopmentCompletedSpinal Cord InjuryUnited States