Skeletal Muscle and Adipose Tissue Responses After Acute Exercise: Comparing Effects of Three Different Intensities (3X)

July 25, 2024 updated by: Jeffrey F Horowitz, University of Michigan
The study will assess the exercise-induced changes in chromatin accessibility and gene expression in a cell type-specific manner in skeletal muscle from healthy adults in response to exercise at three different intensities - 1) low-intensity continuous exercise, 2) moderate-intensity continuous exercise, and 3) high-intensity interval exercise.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age:18-40
  • Body Mass Index: 20-30 kg/m2
  • Must engage in regularly planned aerobic-type exercise at moderate-vigorous intensity, 3 times per week for at least 30-60 minutes/session
  • Women must have regularly occurring menses and must be premenopausal
  • Subject willingness to opt-in for the Michigan Genomics Initiative (MGI) Repository

Exclusion Criteria:

  • Evidence/history of cardiovascular or metabolic disease.
  • Taking anti-coagulate medications or medications known to affect metabolism or inflammation
  • Weight instability ≥ ±3kg in the last 6 months
  • Tobacco or e-cigarette users
  • Women must not be pregnant or actively lactating

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: low-intensity continuous exercise
subjects will exercise at 30% maximal oxygen consumption (VO2max) for 45-60 minutes
Behavioral: Low intensity exercise session
subjects will exercise at 30% maximal oxygen consumption (VO2max) for 45-60 minutes
Experimental: moderate-intensity continuous exercise
subjects will exercise at 65% maximal oxygen consumption (VO2max) for 30-45 minutes
Behavioral: Moderate intensity exercise session
subjects will exercise at 65% maximal oxygen consumption (VO2max) for 30-45 minutes
Experimental: high-intensity interval exercise
subjects will completed 10x1minute exercise intervals at maximal oxygen consumption (VO2max) with 1 minute active recovery between
Behavioral: High intensity exercise session
subjects will completed 10x1minute exercise intervals at maximal oxygen consumption (VO2max) with 1 minute active recovery between

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
post-translational modifications of skeletal muscle oxidative enzymes
Time Frame: 30 minutes before exercise
Western blot
30 minutes before exercise
post-translational modifications of skeletal muscle oxidative enzymes
Time Frame: immediately after exercise
Western blot
immediately after exercise
post-translational modifications of skeletal muscle oxidative enzymes
Time Frame: 60 minutes after exercise
Western blot
60 minutes after exercise
post-translational modifications of Adipose tissue metabolic proteins
Time Frame: 15 minutes before exercise
Western blot
15 minutes before exercise
post-translational modifications of Adipose tissue metabolic proteins
Time Frame: 75 minutes after exercise
Western blot
75 minutes after exercise
mRNA expression of skeletal muscle oxidative enzymes
Time Frame: 30 minutes before exercise
qPCR
30 minutes before exercise
mRNA expression of skeletal muscle oxidative enzymes
Time Frame: immediately after exercise
qPCR
immediately after exercise
mRNA expression of skeletal muscle oxidative enzymes
Time Frame: 60 minutes after exercise
qPCR
60 minutes after exercise
mRNA expression of adipose tissue metabolic enzymes
Time Frame: 15 minutes before exercise
qPCR
15 minutes before exercise
mRNA expression of adipose tissue metabolic enzymes
Time Frame: 75 minutes after exercise
qPCR
75 minutes after exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00204857

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.

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