AgingPhase 1NCT00945256
Muscle Perfusion and Protein Metabolism in Elderly
A Phase 1 study testing Aerobic Exercise, Sodium Nitroprusside and Amino Acid Drink in people with Aging, run by The University of Texas Medical Branch, Galveston.
Trial summary
The purpose of this study was to examine the role skeletal muscle perfusion plays in mediating muscle protein synthesis in healthy older and younger individuals. The investigators hypothesized that normalization of muscle perfusion in older men and women via exercise or infusion of a vasodilator would enhance… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Aerobic Exercise, Sodium Nitroprusside and Amino Acid Drink
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- May 2003to May 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All inclusion criteria must be fulfilled throughout the study. At enrollment, subjects must fit the following criteria:
- Age: young 18-40 yrs; elderly 60-85 yrs.
- Availability of transportation (i.e., subjects must be able to provide their own transportation to UTMB).
- Ability to sign informed consent (score >24 on 30 item mini-mental status exam and no errors on assessment of judgment).
Who cannot join
- None of the following exclusion criteria should be present at enrollment or throughout the study:
- Patients with limiting or unstable angina or who demonstrate cardiac abnormalities such as > 0.2 mV horizontal or downsloping ST segment depression, frequent arrhythmias (>10 PVC/min), or valvular disease.
- Any patient with atrial fibrillation, history of syncope, angina, or congestive heart failure.
- Patients with vascular disease, as determined by the presence of risk factors of peripheral atherosclerosis (i.e., hypertension, obesity, uncontrolled diabetes, and evidence of venous or arterial insufficiency upon palpation of femoral, popliteal, and pedal arteries).
- Peripheral vascular disease as determined by history or abnormal ankle-brachial index by Doppler (< 1.0).
- Any subject with blood pressure on three consecutive measurements taken at rest on separate occasions that has a systolic pressure >170 mm Hg or a diastolic blood pressure >100 mm Hg will be excluded. Subjects will not be included if they are taking blood pressure medication and have a blood pressure above these criteria.
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- Any person HIV-seropositive, with active hepatitis, or any other immunosuppressive or autoimmune disease.
- Any patient taking beta blockers, vasodilators, angiotensin-converting enzyme inhibitors, calcium channel blockers, or alpha blockers.
- Any patient with uncontrolled metabolic diseases including any patient with liver or renal disease.
- Glucose intolerance: fasting plasma glucose concentration 110-126 mg/dL (6.1-7 mmol/L) and/or 2-h plasma glucose 140-200 mg/dL (7.8-11.1 mmol/L) during oral glucose tolerance test (OGTT).
- Currently in muscle strengthening program.
- Total knee replacement or moderate to severe degenerative joint disease of knees.
- Anemia (hemoglobin <13 g/dL in males or <12 g/dL in females).
- Any history of hypo- or hyper-coagulation disorders, including patients taking Coumadin or with a history of deep venous thrombosis (DVT) or pulmonary embolism (PE) at any point in their lifetimes.
- Currently taking aspirin and cannot stop for 7 days (i.e., medical indication for continued aspirin such as transient ischemic attacks).
- Presence of acute illness or metabolically unstable chronic illness.
- Heart disease requiring therapy or recent myocardial infarction (less than 1 year)
- Currently on weight-loss diet.
- Active cancer or in short-term remission (less than 3 years).
- Alcohol or drug abuse.
- History of >20 packs per year cigarette smoking.
- Recent (within 6 months) ingestion or injection or transdermal administration of anabolic steroids, corticosteroids, estrogens, or progestagens.
- History of falls (1 fall in the past year which required medical attention, or more than 2 falls/year regardless of severity).
- Allergy to iodides, penicillin or shellfish.
- Any subject with a know hypersensitivity to octafluoropropane.
- Any subject with a cardiac shunt.
- Any subject with chronic obstructive pulmonary disease (COPD).
About this study
Official title: A Phase I Trial Examining Muscle Perfusion and Protein Metabolism in Elderly and Young
The purpose of this study was to examine the role skeletal muscle perfusion plays in mediating muscle protein synthesis in healthy older and younger individuals. The investigators hypothesized that normalization of muscle perfusion in older men and women via exercise or infusion of a vasodilator would enhance nutritive flow and skeletal muscle protein synthesis in the elderly similar to that of their younger counterparts.
Read the detailed description
The purpose of this study was to examine muscle protein metabolism in healthy young and elderly subjects during pharmacologic vasodilation of the lower limb vasculature in combination with increased amino acids delivery. We obtained femoral arteriovenous blood samples and v. lateralis muscle biopsies during a primed continuous infusion of L-[ring-13C6] Phenylalanine. Muscle protein kinetics were measured in the basal state and during a 180 min infusion of sodium nitroprusside (SNP) and amino acids (Premsol 10%) (SNP+AA). Skeletal muscle microvascular recruitment and flow were measured during the basal state and SNP+AA using contrast-enhanced ultrasound (CEU).
- Conditions
- Aging
- Being tested
- Aerobic Exercise, Sodium Nitroprusside, Amino Acid Drink
- Keywords
- metabolism, exercise, sodium nitroprusside
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
45 minuties of treadmill walking was completed at 40% VO2 peak
Sodium NitroprussideDrug
Also called Nitropress
Sodium Nitroprusside was given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min
Amino Acid DrinkDietary supplement
7.5 gram Amino Acid drink
| Study group | Role | What they receive |
|---|---|---|
| Young Aerobic Exercise | Active comparator | 45 minutes of treadmill walking at 40% VO2 peak Receives: Other: Aerobic Exercise |
| Elderly Aerobic Exercise | Active comparator | 45 minutes of treadmill walking at 40% VO2 peak Receives: Other: Aerobic Exercise |
| Young Sodium Nitroprusside | Active comparator | Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min Receives: Drug: Sodium Nitroprusside |
| Elderly Sodium Nitoprusside | Active comparator | Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min Receives: Drug: Sodium Nitroprusside |
| Elderly Sodium Nitroprusside and Amino Acid Drink | Active comparator | Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5g amino acid drink taken orally Receives: Drug: Sodium Nitroprusside; Dietary Supplement: Amino Acid Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mixed Muscle Fractional Synthesis Rate (FSR)
The rate at which the body makes new muscle was assessed by determining the fractional synthesis rate (FSR). This technique determines how quickly new amino acids are used to make muscle. In this technique, a special (but natural and non-radioactive) version of an amino acid is infused into the blood. This special version of the amino acid is heavier than the most common version the same amino acid. This property allows it to be identified in a muscle sample. By determining how much of the special amino acid has accumulated over time in a muscle sample, the fractional synthesis rate can be determined. For example, if the rate were such that 1 of every 100 amino acids were of the special type after 1 day, the fractional synthesis rate would be 1% per day. In other words, 1/100 of the muscle would be newly made each day.
Measured: Acute ( 8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startMay 2003
- Primary completionMay 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Melinda Sheffield-Moore, PhD, Principal investigator, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945256
- Sponsor's protocol ID
- 03-213
- Other IDs
- R01AG021539
- Status last verified
- Apr 2014
- First submitted
- 22 Jul 2009
- Last updated
- 3 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial Examining Muscle Perfusion and Protein Metabolism in Elderly and Young
- ClinicalTrials.gov ID
- NCT00945256
- Acronym / sponsor ID
- 03-213
- Conditions
- Aging
- Keywords
- metabolism, exercise, sodium nitroprusside
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Posted 5 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to examine the role skeletal muscle perfusion plays in mediating muscle protein synthesis in healthy older and younger individuals. The investigators hypothesized that normalization of muscle perfusion in older men and women via exercise or infusion of a vasodilator would enhance nutritive flow and skeletal muscle protein synthesis in the elderly similar to that of their younger counterparts.
Detailed description
The purpose of this study was to examine muscle protein metabolism in healthy young and elderly subjects during pharmacologic vasodilation of the lower limb vasculature in combination with increased amino acids delivery. We obtained femoral arteriovenous blood samples and v. lateralis muscle biopsies during a primed continuous infusion of L-[ring-13C6] Phenylalanine. Muscle protein kinetics were measured in the basal state and during a 180 min infusion of sodium nitroprusside (SNP) and amino acids (Premsol 10%) (SNP+AA). Skeletal muscle microvascular recruitment and flow were measured during the basal state and SNP+AA using contrast-enhanced ultrasound (CEU).
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Young Aerobic Exercise | Active comparator | Other: Aerobic Exercise45 minutes of treadmill walking at 40% VO2 peak |
| Elderly Aerobic Exercise | Active comparator | Other: Aerobic Exercise45 minutes of treadmill walking at 40% VO2 peak |
| Young Sodium Nitroprusside | Active comparator | Drug: Sodium NitroprussideSodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min |
| Elderly Sodium Nitoprusside | Active comparator | Drug: Sodium NitroprussideSodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min |
| Elderly Sodium Nitroprusside and Amino Acid Drink | Active comparator | Drug: Sodium Nitroprusside, Dietary Supplement: Amino Acid DrinkSodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5g amino acid drink taken orally |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All inclusion criteria must be fulfilled throughout the study. At enrollment, subjects must fit the following criteria:
- Age: young 18-40 yrs; elderly 60-85 yrs.
- Availability of transportation (i.e., subjects must be able to provide their own transportation to UTMB).
- Ability to sign informed consent (score >24 on 30 item mini-mental status exam and no errors on assessment of judgment).
Key exclusion criteria (27 listed)
- None of the following exclusion criteria should be present at enrollment or throughout the study:
- Patients with limiting or unstable angina or who demonstrate cardiac abnormalities such as > 0.2 mV horizontal or downsloping ST segment depression, frequent arrhythmias (>10 PVC/min), or valvular disease.
- Any patient with atrial fibrillation, history of syncope, angina, or congestive heart failure.
- Patients with vascular disease, as determined by the presence of risk factors of peripheral atherosclerosis (i.e., hypertension, obesity, uncontrolled diabetes, and evidence of venous or arterial insufficiency upon palpation of femoral, popliteal, and pedal arteries).
- Peripheral vascular disease as determined by history or abnormal ankle-brachial index by Doppler (< 1.0).
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 |
|---|---|---|
| Aerobic Exercise45 minuties of treadmill walking was completed at 40% VO2 peak | Other | Elderly Aerobic Exercise, Young Aerobic Exercise |
| Sodium NitroprussideAlso: NitropressSodium Nitroprusside was given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min | Drug | Elderly Sodium Nitoprusside, Elderly Sodium Nitroprusside and Amino Acid Drink, Young Sodium Nitroprusside |
| Amino Acid Drink7.5 gram Amino Acid drink | Dietary supplement | Elderly Sodium Nitroprusside and Amino Acid Drink |
Primary outcome
Mixed Muscle Fractional Synthesis Rate (FSR)
Time frame: Acute ( 8 hours)
The rate at which the body makes new muscle was assessed by determining the fractional synthesis rate (FSR). This technique determines how quickly new amino acids are used to make muscle. In this technique, a special (but natural and non-radioactive) version of an amino acid is infused into the blood. This special version of the amino acid is heavier than the most common version the same amino acid. This property allows it to be identified in a muscle sample. By determining how much of the special amino acid has accumulated over time in a muscle sample, the fractional synthesis rate can be determined. For example, if the rate were such that 1 of every 100 amino acids were of the special type after 1 day, the fractional synthesis rate would be 1% per day. In other words, 1/100 of the muscle would be newly made each day.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Melinda Sheffield-Moore, PhD principal investigator
UTMB
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aerobic Exercise, Sodium Nitroprusside and Amino Acid Drink in people with Aging, run by The University of Texas Medical Branch, Galveston.
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 4 inclusion and 27 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 5 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mixed Muscle Fractional Synthesis Rate (FSR) (time frame: Acute ( 8 hours)). 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 3 Feb 2016; AzTrials last refreshed its copy on 6 Nov 2026.