AzTrials
AzTrials

Validation StudiesNCT01827527

Magnetic Resonance & Optical Spectroscopy Validation

An observational study of Validation Studies and Magnetic Resonance Spectroscopy, run by AdventHealth Translational Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to develop and refine techniques for using magnetic resonance and optical spectroscopy to investigate how your body uses energy. Read more about this study

Who is it for?
Ages 18 to 89 yearsHealthy volunteers can take part
How many people
31 participants
Where
1 siteUnited States
Study dates
Mar 2013to 30 Dec 2024
Phase
Observational
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 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Healthy adult volunteers

Who may be able to join

  • Male or female
  • Age 18 - 89
  • Healthy (self assessed)
  • Weight under 350lbs
  • Able to walk 50 yards without stopping
  • Able to travel to hospital for study visits
  • Able to follow a 3-step command
  • Able to remain in magnetic resonance (MR) scanner for up to 2 hours

Who cannot join

  • Have internal metal medical devices, including cardiac pacemakers, aortic or cerebral aneurysm clips, artificial heart valves, ferromagnetic implants, shrapnel, wire sutures, joint replacements, bone or joint pins/rods/screws, metal fragments in your eye, or non-removable jewelry such as rings.
  • Are unwilling or unable to complete the imaging procedures for the duration of the magnetic resonance imaging (MRI) scan due to claustrophobia or other reason.
  • Serious mental illness that might preclude subject's ability to comply with study treatment
  • Are pregnant or plan on becoming pregnant in the next 8 weeks.
  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
  • Varicose Veins
Show all 12Show fewer
  • Known genetic factor (Factor V Leiden, etc.) or hypercoagulable state, including cancer, leukemia - such as chronic myelocytic leukemia (CML), hemoglobinopathies - such as sickle-cell disease and multiple myeloma and other proteinopathies.
  • Diagnosed peripheral arterial or vascular disease
  • Family history of primary DVT or PE
  • Peripheral neuropathy
  • History of chronic venous stasis or lower extremity edema
  • Female taking hormonal birth control (oral or otherwise) AND smoker

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Translational Research Institute for Metabolism and Diabetes

    Orlando, Florida, 32804

Other trials in United States

About this study

Official title: Development and Validation of 31P Magnetic Resonance and Optical Spectroscopy for the Characterization of ATP in Whole Body Human Applications

The purpose of this study is to develop and refine techniques for using magnetic resonance and optical spectroscopy to investigate how your body uses energy.

Read the detailed description

Primary Study Objective:

To evaluate the reproducibility of acquiring multi-nuclear data on a new 3T Philips Magnet in conjunction with Optical Spectroscopy.

Keywords
Adenosine Triphosphate, Validation, Magnetic Resonance Spectroscopy, Optical Spectroscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01827527
Study groupRoleWhat they receive
Healthy AdultThis is a protocol development study, with no interventions or treatments.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of phosphocreatine (PCr) decay

    The PCr decay (rate of PCr breakdown during ischemia) will be used to measure the ATP turnover rates (ATPase).

    After the baseline is established, the volunteer will be asked to perform contractions of the quadriceps (by slight kicking) for up to 45 seconds.

    . After kicking is stopped, the volunteer will remain still for an additional 5 minutes in order to allow the PCr peak to return to baseline. The ATPase experiment will also be performed by acquiring 31P Spectra every 6 seconds.

    Measured: Hour 2

  2. Rate of oxygen uptake

    OS will be used to measure the oxygen (O2) uptake by following the rate of Hb-O2 and Mb-O2 deoxygenation during ischemia. The rate of the depletion of these O2 stores measures the rate of O2 uptake by the mitochondria. The Horbia Jobin Yvon optical system will be used. The OS acquisition procedure has been thoroughly described by Marcinek et.al

    Measured: Hour 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2013 (estimated)
  2. Study startMar 2013
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01827527
Sponsor's protocol ID
TRIMDFH 422234
Status last verified
Apr 2026
First submitted
4 Apr 2013
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Amara CE, Shankland EG, Jubrias SA, Marcinek DJ, Kushmerick MJ, Conley KE. Mild mitochondrial uncoupling impacts cellular aging in human muscles in vivo. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):1057-62. doi: 10.1073/pnas.0610131104. Epub 2007 Jan 10.

    PubMed 17215370

  • Conley KE, Jubrias SA, Amara CE, Marcinek DJ. Mitochondrial dysfunction: impact on exercise performance and cellular aging. Exerc Sport Sci Rev. 2007 Apr;35(2):43-9. doi: 10.1249/JES.0b013e31803e88e9.

    PubMed 17417049

  • Jubrias SA, Esselman PC, Price LB, Cress ME, Conley KE. Large energetic adaptations of elderly muscle to resistance and endurance training. J Appl Physiol (1985). 2001 May;90(5):1663-70. doi: 10.1152/jappl.2001.90.5.1663.

    PubMed 11299253

  • Larson-Meyer DE, Newcomer BR, Hunter GR, Joanisse DR, Weinsier RL, Bamman MM. Relation between in vivo and in vitro measurements of skeletal muscle oxidative metabolism. Muscle Nerve. 2001 Dec;24(12):1665-76. doi: 10.1002/mus.1202.

    PubMed 11745976

  • Larson-Meyer DE, Newcomer BR, Hunter GR, Hetherington HP, Weinsier RL. 31P MRS measurement of mitochondrial function in skeletal muscle: reliability, force-level sensitivity and relation to whole body maximal oxygen uptake. NMR Biomed. 2000 Jan;13(1):14-27. doi: 10.1002/(sici)1099-1492(200002)13:13.0.co;2-0.

    PubMed 10668050

  • Blei ML, Conley KE, Kushmerick MJ. Separate measures of ATP utilization and recovery in human skeletal muscle. J Physiol. 1993 Jun;465:203-22. doi: 10.1113/jphysiol.1993.sp019673.

    PubMed 8024651

  • Larson-Meyer DE, Newcomer BR, Hunter GR, McLean JE, Hetherington HP, Weinsier RL. Effect of weight reduction, obesity predisposition, and aerobic fitness on skeletal muscle mitochondrial function. Am J Physiol Endocrinol Metab. 2000 Jan;278(1):E153-61. doi: 10.1152/ajpendo.2000.278.1.E153.

    PubMed 10644550

  • Newcomer BR, Boska MD, Hetherington HP. Non-P(i) buffer capacity and initial phosphocreatine breakdown and resynthesis kinetics of human gastrocnemius/soleus muscle groups using 0.5 s time-resolved (31)P MRS at 4.1 T. NMR Biomed. 1999 Dec;12(8):545-51. doi: 10.1002/(sici)1099-1492(199912)12:83.0.co;2-j.

    PubMed 10668047

  • Lebon V, Dufour S, Petersen KF, Ren J, Jucker BM, Slezak LA, Cline GW, Rothman DL, Shulman GI. Effect of triiodothyronine on mitochondrial energy coupling in human skeletal muscle. J Clin Invest. 2001 Sep;108(5):733-7. doi: 10.1172/JCI11775.

    PubMed 11544279

  • Johannsen DL, Conley KE, Bajpeyi S, Punyanitya M, Gallagher D, Zhang Z, Covington J, Smith SR, Ravussin E. Ectopic lipid accumulation and reduced glucose tolerance in elderly adults are accompanied by altered skeletal muscle mitochondrial activity. J Clin Endocrinol Metab. 2012 Jan;97(1):242-50. doi: 10.1210/jc.2011-1798. Epub 2011 Nov 2.

    PubMed 22049170

  • Jubrias SA, Crowther GJ, Shankland EG, Gronka RK, Conley KE. Acidosis inhibits oxidative phosphorylation in contracting human skeletal muscle in vivo. J Physiol. 2003 Dec 1;553(Pt 2):589-99. doi: 10.1113/jphysiol.2003.045872. Epub 2003 Sep 26.

    PubMed 14514869

  • Buchli R, Boesiger P. Comparison of methods for the determination of absolute metabolite concentrations in human muscles by 31P MRS. Magn Reson Med. 1993 Nov;30(5):552-8. doi: 10.1002/mrm.1910300505.

    PubMed 8259055

  • Kemper WF, Lindstedt SL, Hartzler LK, Hicks JW, Conley KE. Shaking up glycolysis: Sustained, high lactate flux during aerobic rattling. Proc Natl Acad Sci U S A. 2001 Jan 16;98(2):723-8. doi: 10.1073/pnas.98.2.723. Epub 2000 Dec 19.

    PubMed 11120879

  • Blei ML, Conley KE, Odderson IB, Esselman PC, Kushmerick MJ. Individual variation in contractile cost and recovery in a human skeletal muscle. Proc Natl Acad Sci U S A. 1993 Aug 1;90(15):7396-400. doi: 10.1073/pnas.90.15.7396.

    PubMed 8346262

  • Marcinek DJ, Schenkman KA, Ciesielski WA, Conley KE. Mitochondrial coupling in vivo in mouse skeletal muscle. Am J Physiol Cell Physiol. 2004 Feb;286(2):C457-63. doi: 10.1152/ajpcell.00237.2003. Epub 2003 Oct 1.

    PubMed 14522819

Questions about this trial

What is this clinical trial studying?

An observational study of Validation Studies and Magnetic Resonance Spectroscopy, run by AdventHealth Translational Research Institute 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 8 inclusion and 12 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 17 Apr 2026. 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?

Rate of phosphocreatine (PCr) decay (time frame: Hour 2). The study lists 2 primary outcomes in all. 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 NCT01827527, which also lists 15 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 17 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in