ObesityNCT03411681
Resistance Exercise and Muscle Protein Synthesis in Obese Adults
A study testing Resistance Exercise in people with Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Resistance Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Resistance Exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseOther
Participants will perform 4 sets of 12 repetitions of moderate intensity leg extension
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight | Active comparator | Not described Receives: Other: Resistance Exercise |
| Obese | Experimental | Not described Receives: Other: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myofibrillar protein synthesis
Fractional synthesis rate of myofibrillar proteins
Measured: change over a 300 minute postprandial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Jan 2017
- Primary completion1 Feb 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411681
- Sponsor's protocol ID
- 16699
- Status last verified
- Nov 2017
- First submitted
- 12 Dec 2017
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Exercise as a Strategy to Enhance Postprandial Muscle Protein Synthesis in Obese Adults
- ClinicalTrials.gov ID
- NCT03411681
- Acronym / sponsor ID
- 16699
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Weight | Active comparator | Other: Resistance Exercise |
| Obese | Experimental | Other: Resistance Exercise |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance ExerciseParticipants will perform 4 sets of 12 repetitions of moderate intensity leg extension | Other | Normal Weight, Obese |
Primary outcome
Myofibrillar protein synthesis
Time frame: change over a 300 minute postprandial period
Fractional synthesis rate of myofibrillar proteins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise in people with Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myofibrillar protein synthesis (time frame: change over a 300 minute postprandial period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.