Resistance Exercise and Muscle Protein Synthesis in Obese Adults

April 30, 2018 updated by: University of Illinois at Urbana-Champaign

Resistance Exercise as a Strategy to Enhance Postprandial Muscle Protein Synthesis in Obese Adults

Obesity has numerous comorbidities that are associated with exceedingly high healthcare costs. In addition to well- characterized impairments in lipid and glucose metabolism, obesity is associated with altered protein metabolism. We have recently observed that obese individuals are essentially nonresponsive to protein ingestion with respect to myofibrillar protein synthesis. This suggests that skeletal muscle remodeling in obese individuals is impaired possibly contributing to a poor metabolic quality of muscle. Resistance exercise is known to strongly augment muscle protein synthesis in response to protein ingestion. The purpose of this research is to determine the muscle protein synthetic response during post-exercise recovery in obese individuals. Using stable isotope methodology, we will determine the postprandial muscle protein synthetic response in 14 male and female obese adults (Age: 20-45, BMI: 30-39.9 kg/m2) immediately after an acute bout of resistance exercise. Participants will be sedentary (< 60 min exercise/ week) and weight stable for a minimum of 6 months. During the testing blood and muscle samples will be collected. In addition participants will be asked to perform moderate intensity resistance exercise. Completion of the proposed research will identify the role of resistance exercise in the maintenance of skeletal muscle tissue after the consumption of a protein-dense meal in obese people.

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.

Detailed Description

Baseline procedures:

A parallel group design will be used for this study. Prior to the infusion trial, participants will reported to the laboratory on two separate occasions in the morning. On the first visit, we will determine participants' body weight and height as well as body composition by dual-energy X-ray absorptiometry. Finally, participants will be familiarized with unilateral leg extension and the ten repetition maximum (10RM) procedure. On a separate occasion, each subject will arrive to the lab after an overnight fast for the determination of oral glucose tolerance in response to the consumption of 75 g glucose dissolved in 500 mL of water. At the end of this visit, we will assess participant's unilateral 10RM for leg extension. In addition, participants will be instructed to refrain from vigorous physical activity and alcohol for three days prior to the tracer infusion.

Infusion protocol On the day of the infusion trial, participants will report to the laboratory at ~0700 h after a 10 h fast. An intravenous catheter will be inserted into an antecubital vein for baseline blood sample collection, after which a primed (2 μmol·kg-1), continuous infusion (0.05 μmol·kg Lean Body Mass-1·min-1) of L-[ring-13C6]phenylalanine will be initiated (t=-180 min) and maintained until the end of the trial. A second intravenous catheter placed in a contralateral dorsal hand vein will be placed in a heated blanket for repeated arterialized blood sampling. In the post-absorptive state, muscle biopsies of the vastus lateralis are to be collected at 0 min of infusion from a non-exercised control leg (CON). Subsequently, participants will perform moderate intensity unilateral leg extension exercise. Upon completion, participants will consume 170 g of lean ground pork (36 g protein). Additional muscle biopsies will be collected from both the exercised (EX) and CON legs at 120 and 300 min after pork ingestion. Arterialized blood samples will be collected every 30 or 60 min during the post-absorptive and postprandial-states and placed in pre-chilled EDTA tubes.

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.
19

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 Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Freer Hall

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

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  1. Inclusion criteria

    • Healthy-weight adults: BMI 18-24.9 kg/m2
    • Obese adults: BMI 30-39.9 kg/m2
    • Aged between 20-45 years
    • Healthy
    • Sedentary

  2. Exclusion criteria

    • Smoking
    • Allergies to pork consumption
    • Unusually high protein consumption
    • Vegetarians
    • Phenylketonuria (PKU)
    • Diagnosed GI tract diseases
    • Arthritic conditions
    • A history of neuromuscular problems
    • Previous participation in amino acid tracer studies
    • Predisposition to hypertrophic scarring or keloid formation
    • Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
    • Irregular menstrual cycles during the previous year
    • Pregnancy
    • High BMI that is not representative of being obese (e.g. resistance trained individuals, football players)
    • Contraindications for exercise

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: 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: Obese
Other: Resistance Exercise
Participants will perform 4 sets of 12 repetitions of moderate intensity leg extension
Active Comparator: Normal Weight
Other: Resistance Exercise
Participants will perform 4 sets of 12 repetitions of moderate intensity leg extension

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
Myofibrillar protein synthesis
Time Frame: change over a 300 minute postprandial period
Fractional synthesis rate of myofibrillar proteins
change over a 300 minute postprandial period

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 Illinois at Urbana-Champaign

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.
January 1, 2017

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.
February 1, 2018

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.
May 1, 2018

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).
December 12, 2017

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.
January 19, 2018

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.
January 26, 2018

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.
May 1, 2018

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.
April 30, 2018

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.
November 1, 2017

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.
  • 16699

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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