Human Body CompositionMRS VALIDATIONNCT02663362
Development and Validation of Multi-nuclear Magnetic Resonance Imaging and Spectroscopy for Whole Body Human Applications
An observational study of Human Body Composition and Human Body Function, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to develop and refine the techniques for using magnetic resonance imaging and magnetic resonance spectroscopy to understand the composition and function of the human body Read more about this study
- Who is it for?
- Ages 12 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Body Composition, Human Body Function
- What is being tested?
- To evaluate the reproducibility of acquiring multi-nuclear data on a new 3T Philips Magnet
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 89 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A healthy individual, who is willing and able to undergo MR imaging and spectroscopy for up to two hours at a time
Who may be able to join
- Male or female
- Age 12 - 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 MRI scan due to claustrophobia or other reason.
- Serious mental illness that might preclude subject's ability to comply with study treatment
- Life expectancy of less than 1 year
- Are pregnant or plan on becoming pregnant in the next 8 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
Recruitment Manager, 407-303-7100, tri@flhosp.org
Heather Cornnell, PhD
About this study
The purpose of this study is to develop and refine the techniques for using magnetic resonance imaging and magnetic resonance spectroscopy to understand the composition and function of the human body
- Conditions
- Human Body Composition, Human Body Function
- Being tested
- To evaluate the reproducibility of acquiring multi-nuclear data on a new 3T Philips Magnet
- Keywords
- magnetic resonance imaging, magnetic resonance spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To evaluate the reproducibility of acquiring multi-nuclear data on a new 3T Philips MagnetOther
Outside standard MR instrumentation there will be no interventions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body fat quantification
Measured: 1 hour
Secondary outcomes (1)
Fat Microstructure
A high resolution image of the structure of fat tissue.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startFeb 2012
- Primary completionJun 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Human Body CompositionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Cornnell, PhD, Principal investigator, Translational Research Institute for Metabolism and Diabetes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663362
- Sponsor's protocol ID
- TRIMD FH 306624
- Acronym
- MRS VALIDATION
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2016
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tyler DJ, Hudsmith LE, Clarke K, Neubauer S, Robson MD. A comparison of cardiac (31)P MRS at 1.5 and 3 T. NMR Biomed. 2008 Oct;21(8):793-8. doi: 10.1002/nbm.1255.
PubMed 18512846Muller HP, Raudies F, Unrath A, Neumann H, Ludolph AC, Kassubek J. Quantification of human body fat tissue percentage by MRI. NMR Biomed. 2011 Jan;24(1):17-24. doi: 10.1002/nbm.1549.
PubMed 20672389Price RR, Allison J, Massoth RJ, Clarke GD, Drost DJ; NMR Task Group #8. Practical aspects of functional MRI (NMR Task Group #8). Med Phys. 2002 Aug;29(8):1892-912. doi: 10.1118/1.1494990.
PubMed 12201436Noseworthy MD, Bulte DP, Alfonsi J. BOLD magnetic resonance imaging of skeletal muscle. Semin Musculoskelet Radiol. 2003 Dec;7(4):307-15. doi: 10.1055/s-2004-815678.
PubMed 14735429Lebon 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 11544279Roser W, Beckmann N, Wiesmann U, Seelig J. Absolute quantification of the hepatic glycogen content in a patient with glycogen storage disease by 13C magnetic resonance spectroscopy. Magn Reson Imaging. 1996;14(10):1217-20. doi: 10.1016/s0730-725x(96)00243-3.
PubMed 9065913Beckmann N, Fried R, Turkalj I, Seelig J, Keller U, Stalder G. Noninvasive observation of hepatic glycogen formation in man by 13C MRS after oral and intravenous glucose administration. Magn Reson Med. 1993 May;29(5):583-90. doi: 10.1002/mrm.1910290502.
PubMed 8505893van der Meer RW, Doornbos J, Kozerke S, Schar M, Bax JJ, Hammer S, Smit JW, Romijn JA, Diamant M, Rijzewijk LJ, de Roos A, Lamb HJ. Metabolic imaging of myocardial triglyceride content: reproducibility of 1H MR spectroscopy with respiratory navigator gating in volunteers. Radiology. 2007 Oct;245(1):251-7. doi: 10.1148/radiol.2451061904.
PubMed 17885193Schar M, Kozerke S, Boesiger P. Navigator gating and volume tracking for double-triggered cardiac proton spectroscopy at 3 Tesla. Magn Reson Med. 2004 Jun;51(6):1091-5. doi: 10.1002/mrm.20123.
PubMed 15170826Hudsmith LE, Tyler DJ, Emmanuel Y, Petersen SE, Francis JM, Watkins H, Clarke K, Robson MD, Neubauer S. (31)P cardiac magnetic resonance spectroscopy during leg exercise at 3 Tesla. Int J Cardiovasc Imaging. 2009 Dec;25(8):819-26. doi: 10.1007/s10554-009-9492-8. Epub 2009 Aug 21.
PubMed 19697152Shen W, Mao X, Wang Z, Punyanitya M, Heymsfield SB, Shungu DC. Measurement of intramyocellular lipid levels with 2-D magnetic resonance spectroscopic imaging at 1.5 T. Acta Diabetol. 2003 Oct;40 Suppl 1(Suppl 1):S51-4. doi: 10.1007/s00592-003-0026-x.
PubMed 14618433Shen W, Mao X, Wolper C, Heshka S, Dashnaw S, Hirsch J, Heymsfield SB, Shungu DC. Reproducibility of single- and multi-voxel 1H MRS measurements of intramyocellular lipid in overweight and lean subjects under conditions of controlled dietary calorie and fat intake. NMR Biomed. 2008 Jun;21(5):498-506. doi: 10.1002/nbm.1218.
PubMed 17955571Larson-Meyer DE, Newcomer BR, Hunter GR. Influence of endurance running and recovery diet on intramyocellular lipid content in women: a 1H NMR study. Am J Physiol Endocrinol Metab. 2002 Jan;282(1):E95-E106. doi: 10.1152/ajpendo.2002.282.1.E95.
PubMed 11739089Larson-Meyer DE, Smith SR, Heilbronn LK, Kelley DE, Ravussin E, Newcomer BR; Look AHEAD Adipose Research Group. Muscle-associated triglyceride measured by computed tomography and magnetic resonance spectroscopy. Obesity (Silver Spring). 2006 Jan;14(1):73-87. doi: 10.1038/oby.2006.10.
PubMed 16493125Positano V, Gastaldelli A, Sironi AM, Santarelli MF, Lombardi M, Landini L. An accurate and robust method for unsupervised assessment of abdominal fat by MRI. J Magn Reson Imaging. 2004 Oct;20(4):684-9. doi: 10.1002/jmri.20167.
PubMed 15390229
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Multi-nuclear Magnetic Resonance Imaging and Spectroscopy for Whole Body Human Applications
- ClinicalTrials.gov ID
- NCT02663362
- Acronym / sponsor ID
- MRS VALIDATION / TRIMD FH 306624
- Conditions
- Human Body Composition, Human Body Function
- Keywords
- magnetic resonance imaging, magnetic resonance spectroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Jan 2016 (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.
The purpose of this study is to develop and refine the techniques for using magnetic resonance imaging and magnetic resonance spectroscopy to understand the composition and function of the human body
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A healthy individual, who is willing and able to undergo MR imaging and spectroscopy for up to two hours at a time
Key inclusion criteria (8 listed)
- Male or female
- Age 12 - 89
- Healthy (self assessed)
- Weight under 350lbs
- Able to walk 50 yards without stopping
Key exclusion criteria (5 listed)
- 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 MRI scan due to claustrophobia or other reason.
- Serious mental illness that might preclude subject's ability to comply with study treatment
- Life expectancy of less than 1 year
- Are pregnant or plan on becoming pregnant in the next 8 weeks.
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 |
|---|---|---|
| To evaluate the reproducibility of acquiring multi-nuclear data on a new 3T Philips MagnetOutside standard MR instrumentation there will be no interventions. | Other | – |
Primary outcome
Whole body fat quantification
Time frame: 1 hour
1 secondary outcome
Fat Microstructure
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 18512846Tyler DJ, Hudsmith LE, Clarke K, Neubauer S, Robson MD. A comparison of cardiac (31)P MRS at 1.5 and 3 T. NMR Biomed. 2008 Oct;21(8):793-8. doi: 10.1002/nbm.1255.
- Background: PubMed 20672389Muller HP, Raudies F, Unrath A, Neumann H, Ludolph AC, Kassubek J. Quantification of human body fat tissue percentage by MRI. NMR Biomed. 2011 Jan;24(1):17-24. doi: 10.1002/nbm.1549.
- Background: PubMed 12201436Price RR, Allison J, Massoth RJ, Clarke GD, Drost DJ; NMR Task Group #8. Practical aspects of functional MRI (NMR Task Group #8). Med Phys. 2002 Aug;29(8):1892-912. doi: 10.1118/1.1494990.
- Background: PubMed 14735429Noseworthy MD, Bulte DP, Alfonsi J. BOLD magnetic resonance imaging of skeletal muscle. Semin Musculoskelet Radiol. 2003 Dec;7(4):307-15. doi: 10.1055/s-2004-815678.
- Background: PubMed 11544279Lebon 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.
- Background: PubMed 9065913Roser W, Beckmann N, Wiesmann U, Seelig J. Absolute quantification of the hepatic glycogen content in a patient with glycogen storage disease by 13C magnetic resonance spectroscopy. Magn Reson Imaging. 1996;14(10):1217-20. doi: 10.1016/s0730-725x(96)00243-3.
- Background: PubMed 8505893Beckmann N, Fried R, Turkalj I, Seelig J, Keller U, Stalder G. Noninvasive observation of hepatic glycogen formation in man by 13C MRS after oral and intravenous glucose administration. Magn Reson Med. 1993 May;29(5):583-90. doi: 10.1002/mrm.1910290502.
- Background: PubMed 17885193van der Meer RW, Doornbos J, Kozerke S, Schar M, Bax JJ, Hammer S, Smit JW, Romijn JA, Diamant M, Rijzewijk LJ, de Roos A, Lamb HJ. Metabolic imaging of myocardial triglyceride content: reproducibility of 1H MR spectroscopy with respiratory navigator gating in volunteers. Radiology. 2007 Oct;245(1):251-7. doi: 10.1148/radiol.2451061904.
- Background: PubMed 15170826Schar M, Kozerke S, Boesiger P. Navigator gating and volume tracking for double-triggered cardiac proton spectroscopy at 3 Tesla. Magn Reson Med. 2004 Jun;51(6):1091-5. doi: 10.1002/mrm.20123.
- Background: PubMed 19697152Hudsmith LE, Tyler DJ, Emmanuel Y, Petersen SE, Francis JM, Watkins H, Clarke K, Robson MD, Neubauer S. (31)P cardiac magnetic resonance spectroscopy during leg exercise at 3 Tesla. Int J Cardiovasc Imaging. 2009 Dec;25(8):819-26. doi: 10.1007/s10554-009-9492-8. Epub 2009 Aug 21.
- Background: PubMed 14618433Shen W, Mao X, Wang Z, Punyanitya M, Heymsfield SB, Shungu DC. Measurement of intramyocellular lipid levels with 2-D magnetic resonance spectroscopic imaging at 1.5 T. Acta Diabetol. 2003 Oct;40 Suppl 1(Suppl 1):S51-4. doi: 10.1007/s00592-003-0026-x.
- Background: PubMed 17955571Shen W, Mao X, Wolper C, Heshka S, Dashnaw S, Hirsch J, Heymsfield SB, Shungu DC. Reproducibility of single- and multi-voxel 1H MRS measurements of intramyocellular lipid in overweight and lean subjects under conditions of controlled dietary calorie and fat intake. NMR Biomed. 2008 Jun;21(5):498-506. doi: 10.1002/nbm.1218.
- Individual participant dataSharing planned: No
Related trials for Human Body Composition
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Active, not recruitingObservational study
Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70)
Geriatric Assessment, Advanced Cancer
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
RecruitingObservational study
Multimodal Assessment of Sarcopenia Using Shear Wave Elastography, Dual-Energy X-ray Absorptiometry, Bioelectrical Impedance Analysis, and Physical Performance Measures
Sacropenia
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.
Heather Cornnell, PhD principal investigator
Translational Research Institute for Metabolism and Diabetes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Body Composition and Human Body Function, 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 5 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: looking for participants now, as of the sponsor's last update on 30 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Recruitment Department (407-303-7100, tri@flhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body fat quantification (time frame: 1 hour). 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 NCT02663362, which also lists 18 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 30 Mar 2026.