ObesityPhase 1NCT01824173
Muscle Protein Metabolism in Obesity
A Phase 1 study testing Increase in the levels of plasma amino acids and Aerobic exercise in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
Obesity is associated with reduced adenosine triphosphate (ATP) turnover in skeletal muscle, a condition that can impair muscle metabolism. The proposed research will discover mechanisms responsible for decreased content in mitochondrial proteins as well as in protein β-F1-ATPase, which is directly responsible for ATP… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Increase in the levels of plasma amino acids and Aerobic exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 7 Feb 2020
- Phase
- Phase 1
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI): lean, 19-26 kg/m2; obese, 30-40 kg/m2
- Availability of transportation
- Ability to sign informed consent form
Who cannot join
- Medication or supplements (i.e. amino acids, protein) known to affect protein metabolism
- Presence of acute illness
- History of liver disease
- Uncontrolled metabolic disease
- ECG documented abnormalities, atrial fibrillation, history of syncope, limiting or unstable angina, or congestive heart failure
- Chronically elevated blood pressure (systolic, >140 mmHg; diastolic, >100 mmHg)
Show all 11Show fewer
- Cardiac pacemaker or other medical device implanted in the body
- Low hemoglobin or hematocrit
- Current participation in a weight-loss regimen, including extreme dietary practices
- Smoking
- Use of anabolic steroids or corticosteroids (within 3 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regulation of Muscle ATP Synthase Beta Subunit Metabolism in Obesity
Obesity is associated with reduced adenosine triphosphate (ATP) turnover in skeletal muscle, a condition that can impair muscle metabolism. The proposed research will discover mechanisms responsible for decreased content in mitochondrial proteins as well as in protein β-F1-ATPase, which is directly responsible for ATP assembly, in the muscle of obese individuals. This research will further examine the effectiveness of interventions, such as increased plasma amino acid availability and exercise, to increase the rate of production of mitochondrial proteins as well as that of β-F1-ATPase in the muscle of obese individuals. The findings will help to develop appropriate interventions to improve muscle ATP turnover and metabolism in obese people.
- Conditions
- Obesity
- Being tested
- Increase in the levels of plasma amino acids, Aerobic exercise
- Keywords
- muscle, mitochondria, amino acids, exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase in the levels of plasma amino acidsOther
Aminosyn 15%; 160 mg/kg FFM/h for 4 hours
Aerobic exerciseOther
Moderate intensity for 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Amino Acid Infusion in Lean | Experimental | Amino Acid Infusion in Lean Receives: Other: Increase in the levels of plasma amino acids |
| Amino acid Infusion in Obese | Experimental | Amino acid Infusion in Obese Receives: Other: Increase in the levels of plasma amino acids |
| Exercise in lean | Experimental | Exercise in lean Receives: Other: Aerobic exercise |
| Exercise in Obese | Experimental | Exercise in Obese Receives: Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of synthesis of muscle proteins (mixed muscle proteins, mitochondrial proteins, β-F1-ATPase)
Measured: Measured during a 9-hour infusion study
Secondary outcomes (1)
β-F1-ATPase mRNA expression; PGC-1 expression
Measured: Measured during a 9-hour infusion study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startOct 2012
- Primary completion9 Feb 2017
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori R. Roust, Mayo Clinic
- Investigators
- Lori Roust, MD, Principal investigator, Mayo ClinicChristos S Katsanos, PhD, Principal investigator, Arizona State University/Mayo Clinic Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824173
- Sponsor's protocol ID
- 12-004000
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2013
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Serrano N, Tran L, Hoffman N, Roust L, De Filippis EA, Carroll CC, Patel SH, Kras KA, Buras M, Katsanos CS. Lack of Increase in Muscle Mitochondrial Protein Synthesis During the Course of Aerobic Exercise and Its Recovery in the Fasting State Irrespective of Obesity. Front Physiol. 2021 Aug 2;12:702742. doi: 10.3389/fphys.2021.702742. eCollection 2021.
PubMed 34408662Kras KA, Langlais PR, Hoffman N, Roust LR, Benjamin TR, De Filippis EA, Dinu V, Katsanos CS. Obesity modifies the stoichiometry of mitochondrial proteins in a way that is distinct to the subcellular localization of the mitochondria in skeletal muscle. Metabolism. 2018 Dec;89:18-26. doi: 10.1016/j.metabol.2018.09.006. Epub 2018 Sep 22.
PubMed 30253140Tran L, Kras KA, Hoffman N, Ravichandran J, Dickinson JM, D'Lugos A, Carroll CC, Patel SH, Mandarino LJ, Roust L, Katsanos CS. Lower Fasted-State but Greater Increase in Muscle Protein Synthesis in Response to Elevated Plasma Amino Acids in Obesity. Obesity (Silver Spring). 2018 Jul;26(7):1179-1187. doi: 10.1002/oby.22213. Epub 2018 Jun 12.
PubMed 29896930Kras KA, Hoffman N, Roust LR, Patel SH, Carroll CC, Katsanos CS. Plasma Amino Acids Stimulate Uncoupled Respiration of Muscle Subsarcolemmal Mitochondria in Lean but Not Obese Humans. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4515-4525. doi: 10.1210/jc.2017-01201.
PubMed 29029131
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Muscle ATP Synthase Beta Subunit Metabolism in Obesity
- ClinicalTrials.gov ID
- NCT01824173
- Acronym / sponsor ID
- 12-004000
- Conditions
- Obesity
- Keywords
- muscle, mitochondria, amino acids, exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2012 (actual)
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 4 Apr 2013 (estimated)
- 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 is associated with reduced adenosine triphosphate (ATP) turnover in skeletal muscle, a condition that can impair muscle metabolism. The proposed research will discover mechanisms responsible for decreased content in mitochondrial proteins as well as in protein β-F1-ATPase, which is directly responsible for ATP assembly, in the muscle of obese individuals. This research will further examine the effectiveness of interventions, such as increased plasma amino acid availability and exercise, to increase the rate of production of mitochondrial proteins as well as that of β-F1-ATPase in the muscle of obese individuals. The findings will help to develop appropriate interventions to improve muscle ATP turnover and metabolism in obese people.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Amino Acid Infusion in Lean | Experimental | Other: Increase in the levels of plasma amino acidsAmino Acid Infusion in Lean |
| Amino acid Infusion in Obese | Experimental | Other: Increase in the levels of plasma amino acidsAmino acid Infusion in Obese |
| Exercise in lean | Experimental | Other: Aerobic exerciseExercise in lean |
| Exercise in Obese | Experimental | Other: Aerobic exerciseExercise in Obese |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI): lean, 19-26 kg/m2; obese, 30-40 kg/m2
- Availability of transportation
- Ability to sign informed consent form
Key exclusion criteria (11 listed)
- Medication or supplements (i.e. amino acids, protein) known to affect protein metabolism
- Presence of acute illness
- History of liver disease
- Uncontrolled metabolic disease
- ECG documented abnormalities, atrial fibrillation, history of syncope, limiting or unstable angina, or congestive heart failure
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 |
|---|---|---|
| Increase in the levels of plasma amino acidsAminosyn 15%; 160 mg/kg FFM/h for 4 hours | Other | Amino Acid Infusion in Lean, Amino acid Infusion in Obese |
| Aerobic exerciseModerate intensity for 45 minutes | Other | Exercise in Obese, Exercise in lean |
Primary outcome
Rate of synthesis of muscle proteins (mixed muscle proteins, mitochondrial proteins, β-F1-ATPase)
Time frame: Measured during a 9-hour infusion study
1 secondary outcome
β-F1-ATPase mRNA expression; PGC-1 expression
Time frame: Measured during a 9-hour infusion study
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 3 Apr 2020.
- Derived from this study: PubMed 34408662Serrano N, Tran L, Hoffman N, Roust L, De Filippis EA, Carroll CC, Patel SH, Kras KA, Buras M, Katsanos CS. Lack of Increase in Muscle Mitochondrial Protein Synthesis During the Course of Aerobic Exercise and Its Recovery in the Fasting State Irrespective of Obesity. Front Physiol. 2021 Aug 2;12:702742. doi: 10.3389/fphys.2021.702742. eCollection 2021.
- Derived from this study: PubMed 30253140Kras KA, Langlais PR, Hoffman N, Roust LR, Benjamin TR, De Filippis EA, Dinu V, Katsanos CS. Obesity modifies the stoichiometry of mitochondrial proteins in a way that is distinct to the subcellular localization of the mitochondria in skeletal muscle. Metabolism. 2018 Dec;89:18-26. doi: 10.1016/j.metabol.2018.09.006. Epub 2018 Sep 22.
- Derived from this study: PubMed 29896930Tran L, Kras KA, Hoffman N, Ravichandran J, Dickinson JM, D'Lugos A, Carroll CC, Patel SH, Mandarino LJ, Roust L, Katsanos CS. Lower Fasted-State but Greater Increase in Muscle Protein Synthesis in Response to Elevated Plasma Amino Acids in Obesity. Obesity (Silver Spring). 2018 Jul;26(7):1179-1187. doi: 10.1002/oby.22213. Epub 2018 Jun 12.
- Derived from this study: PubMed 29029131Kras KA, Hoffman N, Roust LR, Patel SH, Carroll CC, Katsanos CS. Plasma Amino Acids Stimulate Uncoupled Respiration of Muscle Subsarcolemmal Mitochondria in Lean but Not Obese Humans. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4515-4525. doi: 10.1210/jc.2017-01201.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Lori Roust, MD principal investigator
Mayo Clinic
Christos S Katsanos, PhD principal investigator
Arizona State University/Mayo Clinic Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Increase in the levels of plasma amino acids and Aerobic exercise in people with Obesity, run by Mayo Clinic 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?
The sponsor lists 3 inclusion and 11 exclusion criteria. 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 3 Apr 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of synthesis of muscle proteins (mixed muscle proteins, mitochondrial proteins, β-F1-ATPase) (time frame: Measured during a 9-hour infusion study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01824173, which also lists 4 linked publications.
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 3 Apr 2020.