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

NCT ID: NCT05034380

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-14

Study Completion Date

2016-03-14

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.

Conditions

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Obesity Type 2 Diabetes Cardiovascular Diseases Acute Exercise

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

All participants underwent the same exact study protocol on random days throughout the study period.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
Investigators conducting molecular analysis were blinded to study samples/groups.

Study Groups

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Lean

males aged 18-30 years with BMI \< 25

Group Type ACTIVE_COMPARATOR

Acute exercise

Intervention Type 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.

Overweight/Obese

males aged 18-30 years with BMI \>= 25

Group Type EXPERIMENTAL

Acute exercise

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Purdue University

OTHER

Sponsor Role collaborator

Louisiana State University Health Sciences Center Shreveport

OTHER

Sponsor Role collaborator

East Carolina University

OTHER

Sponsor Role lead

Responsible Party

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Jessica Ellis

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tara Henagan, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University, Louisiana State University Medical School at Shreveport

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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AcuteExerciseNucleo

Identifier Type: -

Identifier Source: org_study_id

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