ObesityColumbusNCT01911091
Identification of Novel Skeletal Muscle-derived Factors That Promote Lipid Oxidation (Columbus)
A study testing Exercise in people with Obesity and Disorder of Lipid Storage and Metabolism, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to collect data to help researchers identify factors, such as certain proteins or genetic codes, that are secreted from muscle that are associated with the beneficial effects of exercise. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Disorder of Lipid Storage and Metabolism, Lipid Metabolism Disorders
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2026
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Applicable to all Groups
- Healthy men and women, aged 18 - 40, inclusive.
- Willing to stop alcohol and caffeine consumption for 48 hours preceding each blood draw
- Applicable to Group 1
- BMI between 22 and 29.9 kg/m2
- Not involved in regular exercise program
Show all 15Show fewer
- Willing to exercise every day for the study period
- Applicable to Group 2
- BMI between 22 and 29.9 kg/m2
- Maximal oxygen uptake (VO2max) ≥ 45 ml/kg fat-free mass
- /min
- Engaged in a minimum of 1.5 h of moderate to vigorous intensity aerobic exercise 3 times/ week
- Applicable to Group 3
- BMI ≥ 30 kg/m2 and weight ≤ 350 lbs
- Not involved in a regular exercise program
Who cannot join
- Applicable to All Groups
- History of Type 2 Diabetes
- "Unfavorable anatomy" for continuous venous blood sample collection
- Abnormal resting ECG
- Significant renal, cardiac, liver, lung, or neurological disease (controlled hypertension is acceptable if baseline bp < 140/90 on medications)
- Use of drugs known to affect energy metabolism or body weight: including, but not limited to: orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc
Show all 38Show fewer
- Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures
- New onset (<3 months on a stable regime) use of oral contraceptives or hormone replacement therapy
- Alcohol or other drug abuse
- Smoking within the past 3 months
- Females that are currently or have been pregnant or are currently or have nursed a child within the last 12 months (minimum).
- Parental enrollment into the study that compromises the well being of the child [no partner or connected caregiver]
- Unwilling or unable to abstain from caffeine or alcohol 48 hours prior to metabolic rate measurements
- Increased liver function tests
- Metal objects that would interfere with the measurement of body composition /magnetic resonance spectroscopy such as implanted rods, surgical clips, etc
- Any New York Heart Association class of congestive heart failure
- History of deep vein thrombosis or pulmonary embolism
- Significant varicose veins
- Abnormal blood count/Anemia, or blood donation within the last 2 months
- Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
- Bariatric surgery or liposuction within the previous 3 years
- Cancer (active malignancy with or without concurrent chemotherapy)
- Rheumatoid disease
- Bypass graft in limb
- Known genetic factor (Factor V Leiden, etc) or hypercoagulable state
- Diagnosed peripheral arterial or vascular disease, or intermittent claudication
- Family history of primary deep vein thrombosis or pulmonary embolism
- Peripheral neuropathy
- Claustrophobia
- Frequent nocturnal urination and/or sleep apnea
- Presence of any condition that, in the opinion of the investigator, compromises participant safety or data integrity or the participants' ability to complete the training protocol
- Applicable to Group 2
- Gait problems
- Major Depression
- Presence of an eating disorder or eating attitudes/behaviors that could interfere with the study completion
- Unwilling or unable to complete the protocol
- Applicable to Group 3
- HbA1c ≥ 6.5% (O)
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
About this study
Official title: Identification of Novel Skeletal Muscle-derived Factors That Promote Lipid Oxidation in Both Skeletal Muscle and Adipose Tissue
The purpose of this study is to collect data to help researchers identify factors, such as certain proteins or genetic codes, that are secreted from muscle that are associated with the beneficial effects of exercise.
Read the detailed description
Study Objectives:
- To identify specific changes in messenger ribonucleic acid (mRNA)/micro ribonucleic acid (miRNA) expression in muscle associated with higher or lower relative measures of mitochondrial capacity and fat oxidation.
- To identify secreted factors/miRNAs that specifically relate to the metabolic response of muscle and that are present after a single initial bout of exercise.
- To collect the appropriate clinical samples (muscle and adipose tissue, plasma/serum) to enable validation of myokines associated with changes in oxygen consumption/mitochondrial content via in vivo and in vitro discovery efforts.
- Conditions
- Obesity, Disorder of Lipid Storage and Metabolism, Lipid Metabolism Disorders, Metabolic Disorder
- Being tested
- Exercise
- Keywords
- skeletal muscle, adipose tissue, metabolism, oxidation, mitochondrial capacity
- Medical subject headings
- Obesity, Lipid Metabolism Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
A 5-minute warm-up and a 5-minute cool-down prior to and following each exercise session, respectively. There will be alternating days of interval training and aerobic training. The interval training will be performed on an upright stationary bike, while the aerobic training will be performed on a treadmill. The interval training will consist of five-minute bouts of higher intensity alternated with 4 minutes of lower intensity for a total duration of 45 minutes. Intensity will increase each week. The aerobic training component will be fixed at a moderate intensity, but will increase in duration each week from 45 minutes to 75 minutes to 90 minutes during the third and final week.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Regular exercise | Experimental | Alternate interval training and aerobic training and exercise Receives: Behavioral: Exercise |
| Group 2 - Athlete exercise | No intervention | Athletes are not given any intervention |
| Group 3 - Obese No Exercise | No intervention | The Obese group will not receive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure change in mitochondrial capacity
The difference will be measured in obese, lean and athletic participants.
The Phosphocreatine (PCr) recovery time constant and the PCr level in oxygenated muscle at rest will be used to calculate maximum mitochondrial capacity.
Measured: Baseline (Day -6), Day 18
Secondary outcomes (2)
Measure change of expression of proteins
The difference will be measured in obese, lean and athletic participants.
This will be taken from muscle biopsy and/or blood plasma samples obtained at baseline, before and after exercise.
Measured: Baseline (Day -6), Day 0, Day 5, Day 12, Day 18
Measure change in mRNA/miRNA levels
The difference will be measured in obese, lean and athletic participants.
This will be taken from muscle biopsy and/or blood plasma samples obtained at baseline, before and after exercise.
Measured: Baseline (Day -6), Day 0, Day 5, Day 12, Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (82)Papers the sponsor has linked to this study.
- 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sanford-Burnham Medical Research Institute, Takeda
- Responsible party
- Sponsor
- Investigators
- Lauren Sparks, PhD, Principal investigator, Translational Research Institute for Metabolism and Diabetes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911091
- Sponsor's protocol ID
- TRIMDFH 460196
- Acronym
- Columbus
- Status last verified
- Mar 2026
- First submitted
- 24 Jul 2013
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
PubMed 11333990Nocon M, Hiemann T, Muller-Riemenschneider F, Thalau F, Roll S, Willich SN. Association of physical activity with all-cause and cardiovascular mortality: a systematic review and meta-analysis. Eur J Cardiovasc Prev Rehabil. 2008 Jun;15(3):239-46. doi: 10.1097/HJR.0b013e3282f55e09.
PubMed 18525377Pedersen BK, Febbraio MA. Muscles, exercise and obesity: skeletal muscle as a secretory organ. Nat Rev Endocrinol. 2012 Apr 3;8(8):457-65. doi: 10.1038/nrendo.2012.49.
PubMed 22473333Pedersen BK, Febbraio MA. Muscle as an endocrine organ: focus on muscle-derived interleukin-6. Physiol Rev. 2008 Oct;88(4):1379-406. doi: 10.1152/physrev.90100.2007.
PubMed 18923185Pedersen BK, Fischer CP. Beneficial health effects of exercise--the role of IL-6 as a myokine. Trends Pharmacol Sci. 2007 Apr;28(4):152-6. doi: 10.1016/j.tips.2007.02.002. Epub 2007 Feb 28.
PubMed 17331593Pedersen BK, Steensberg A, Fischer C, Keller C, Keller P, Plomgaard P, Febbraio M, Saltin B. Searching for the exercise factor: is IL-6 a candidate? J Muscle Res Cell Motil. 2003;24(2-3):113-9. doi: 10.1023/a:1026070911202.
PubMed 14609022MacIntyre DL, Sorichter S, Mair J, Berg A, McKenzie DC. Markers of inflammation and myofibrillar proteins following eccentric exercise in humans. Eur J Appl Physiol. 2001 Mar;84(3):180-6. doi: 10.1007/s004210170002.
PubMed 11320633Nielsen AR, Pedersen BK. The biological roles of exercise-induced cytokines: IL-6, IL-8, and IL-15. Appl Physiol Nutr Metab. 2007 Oct;32(5):833-9. doi: 10.1139/H07-054.
PubMed 18059606Matthews VB, Astrom MB, Chan MH, Bruce CR, Krabbe KS, Prelovsek O, Akerstrom T, Yfanti C, Broholm C, Mortensen OH, Penkowa M, Hojman P, Zankari A, Watt MJ, Bruunsgaard H, Pedersen BK, Febbraio MA. Brain-derived neurotrophic factor is produced by skeletal muscle cells in response to contraction and enhances fat oxidation via activation of AMP-activated protein kinase. Diabetologia. 2009 Jul;52(7):1409-18. doi: 10.1007/s00125-009-1364-1. Epub 2009 Apr 22.
PubMed 19387610Krabbe KS, Nielsen AR, Krogh-Madsen R, Plomgaard P, Rasmussen P, Erikstrup C, Fischer CP, Lindegaard B, Petersen AM, Taudorf S, Secher NH, Pilegaard H, Bruunsgaard H, Pedersen BK. Brain-derived neurotrophic factor (BDNF) and type 2 diabetes. Diabetologia. 2007 Feb;50(2):431-8. doi: 10.1007/s00125-006-0537-4. Epub 2006 Dec 7.
PubMed 17151862Arner P, Pettersson A, Mitchell PJ, Dunbar JD, Kharitonenkov A, Ryden M. FGF21 attenuates lipolysis in human adipocytes - a possible link to improved insulin sensitivity. FEBS Lett. 2008 May 28;582(12):1725-30. doi: 10.1016/j.febslet.2008.04.038. Epub 2008 May 5.
PubMed 18460341Badman MK, Pissios P, Kennedy AR, Koukos G, Flier JS, Maratos-Flier E. Hepatic fibroblast growth factor 21 is regulated by PPARalpha and is a key mediator of hepatic lipid metabolism in ketotic states. Cell Metab. 2007 Jun;5(6):426-37. doi: 10.1016/j.cmet.2007.05.002.
PubMed 17550778Coskun T, Bina HA, Schneider MA, Dunbar JD, Hu CC, Chen Y, Moller DE, Kharitonenkov A. Fibroblast growth factor 21 corrects obesity in mice. Endocrinology. 2008 Dec;149(12):6018-27. doi: 10.1210/en.2008-0816. Epub 2008 Aug 7.
PubMed 18687777Inagaki T, Dutchak P, Zhao G, Ding X, Gautron L, Parameswara V, Li Y, Goetz R, Mohammadi M, Esser V, Elmquist JK, Gerard RD, Burgess SC, Hammer RE, Mangelsdorf DJ, Kliewer SA. Endocrine regulation of the fasting response by PPARalpha-mediated induction of fibroblast growth factor 21. Cell Metab. 2007 Jun;5(6):415-25. doi: 10.1016/j.cmet.2007.05.003.
PubMed 17550777Kharitonenkov A, Shiyanova TL, Koester A, Ford AM, Micanovic R, Galbreath EJ, Sandusky GE, Hammond LJ, Moyers JS, Owens RA, Gromada J, Brozinick JT, Hawkins ED, Wroblewski VJ, Li DS, Mehrbod F, Jaskunas SR, Shanafelt AB. FGF-21 as a novel metabolic regulator. J Clin Invest. 2005 Jun;115(6):1627-35. doi: 10.1172/JCI23606. Epub 2005 May 2.
PubMed 15902306
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
- Identification of Novel Skeletal Muscle-derived Factors That Promote Lipid Oxidation in Both Skeletal Muscle and Adipose Tissue
- ClinicalTrials.gov ID
- NCT01911091
- Acronym / sponsor ID
- Columbus / TRIMDFH 460196
- Conditions
- Obesity, Disorder of Lipid Storage and Metabolism, Lipid Metabolism Disorders, Metabolic Disorder
- Keywords
- skeletal muscle, adipose tissue, metabolism, oxidation, mitochondrial capacity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Collaborators
- Sanford-Burnham Medical Research Institute, Takeda
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jul 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.
The purpose of this study is to collect data to help researchers identify factors, such as certain proteins or genetic codes, that are secreted from muscle that are associated with the beneficial effects of exercise.
Detailed description
Study Objectives:
- To identify specific changes in messenger ribonucleic acid (mRNA)/micro ribonucleic acid (miRNA) expression in muscle associated with higher or lower relative measures of mitochondrial capacity and fat oxidation.
- To identify secreted factors/miRNAs that specifically relate to the metabolic response of muscle and that are present after a single initial bout of exercise.
- To collect the appropriate clinical samples (muscle and adipose tissue, plasma/serum) to enable validation of myokines associated with changes in oxygen consumption/mitochondrial content via in vivo and in vitro discovery efforts.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Regular exercise | Experimental | Behavioral: ExerciseAlternate interval training and aerobic training and exercise |
| Group 2 - Athlete exercise | No intervention | –Athletes are not given any intervention |
| Group 3 - Obese No Exercise | No intervention | –The Obese group will not receive intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Applicable to all Groups
- Healthy men and women, aged 18 - 40, inclusive.
- Willing to stop alcohol and caffeine consumption for 48 hours preceding each blood draw
- Applicable to Group 1
- BMI between 22 and 29.9 kg/m2
Key exclusion criteria (38 listed)
- Applicable to All Groups
- History of Type 2 Diabetes
- "Unfavorable anatomy" for continuous venous blood sample collection
- Abnormal resting ECG
- Significant renal, cardiac, liver, lung, or neurological disease (controlled hypertension is acceptable if baseline bp < 140/90 on medications)
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 |
|---|---|---|
| ExerciseA 5-minute warm-up and a 5-minute cool-down prior to and following each exercise session, respectively. There will be alternating days of interval training and aerobic training. The interval training will be performed on an upright stationary bike, while the aerobic training will be performed on a treadmill. The interval training will consist of five-minute bouts of higher intensity alternated with 4 minutes of lower intensity for a total duration of 45 minutes. Intensity will increase each week. The aerobic training component will be fixed at a moderate intensity, but will increase in duration each week from 45 minutes to 75 minutes to 90 minutes during the third and final week. | Behavioural | Group 1 - Regular exercise |
Primary outcome
Measure change in mitochondrial capacity
Time frame: Baseline (Day -6), Day 18
The difference will be measured in obese, lean and athletic participants. The Phosphocreatine (PCr) recovery time constant and the PCr level in oxygenated muscle at rest will be used to calculate maximum mitochondrial capacity.
2 secondary outcomes
Measure change of expression of proteins
Time frame: Baseline (Day -6), Day 0, Day 5, Day 12, Day 18
Measure change in mRNA/miRNA levels
Time frame: Baseline (Day -6), Day 0, Day 5, Day 12, Day 18
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 11333990Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
- Background: PubMed 18525377Nocon M, Hiemann T, Muller-Riemenschneider F, Thalau F, Roll S, Willich SN. Association of physical activity with all-cause and cardiovascular mortality: a systematic review and meta-analysis. Eur J Cardiovasc Prev Rehabil. 2008 Jun;15(3):239-46. doi: 10.1097/HJR.0b013e3282f55e09.
- Background: PubMed 22473333Pedersen BK, Febbraio MA. Muscles, exercise and obesity: skeletal muscle as a secretory organ. Nat Rev Endocrinol. 2012 Apr 3;8(8):457-65. doi: 10.1038/nrendo.2012.49.
- Background: PubMed 18923185Pedersen BK, Febbraio MA. Muscle as an endocrine organ: focus on muscle-derived interleukin-6. Physiol Rev. 2008 Oct;88(4):1379-406. doi: 10.1152/physrev.90100.2007.
- Background: PubMed 17331593Pedersen BK, Fischer CP. Beneficial health effects of exercise--the role of IL-6 as a myokine. Trends Pharmacol Sci. 2007 Apr;28(4):152-6. doi: 10.1016/j.tips.2007.02.002. Epub 2007 Feb 28.
- Background: PubMed 14609022Pedersen BK, Steensberg A, Fischer C, Keller C, Keller P, Plomgaard P, Febbraio M, Saltin B. Searching for the exercise factor: is IL-6 a candidate? J Muscle Res Cell Motil. 2003;24(2-3):113-9. doi: 10.1023/a:1026070911202.
- Background: PubMed 11320633MacIntyre DL, Sorichter S, Mair J, Berg A, McKenzie DC. Markers of inflammation and myofibrillar proteins following eccentric exercise in humans. Eur J Appl Physiol. 2001 Mar;84(3):180-6. doi: 10.1007/s004210170002.
- Background: PubMed 18059606Nielsen AR, Pedersen BK. The biological roles of exercise-induced cytokines: IL-6, IL-8, and IL-15. Appl Physiol Nutr Metab. 2007 Oct;32(5):833-9. doi: 10.1139/H07-054.
- Background: PubMed 19387610Matthews VB, Astrom MB, Chan MH, Bruce CR, Krabbe KS, Prelovsek O, Akerstrom T, Yfanti C, Broholm C, Mortensen OH, Penkowa M, Hojman P, Zankari A, Watt MJ, Bruunsgaard H, Pedersen BK, Febbraio MA. Brain-derived neurotrophic factor is produced by skeletal muscle cells in response to contraction and enhances fat oxidation via activation of AMP-activated protein kinase. Diabetologia. 2009 Jul;52(7):1409-18. doi: 10.1007/s00125-009-1364-1. Epub 2009 Apr 22.
- Background: PubMed 17151862Krabbe KS, Nielsen AR, Krogh-Madsen R, Plomgaard P, Rasmussen P, Erikstrup C, Fischer CP, Lindegaard B, Petersen AM, Taudorf S, Secher NH, Pilegaard H, Bruunsgaard H, Pedersen BK. Brain-derived neurotrophic factor (BDNF) and type 2 diabetes. Diabetologia. 2007 Feb;50(2):431-8. doi: 10.1007/s00125-006-0537-4. Epub 2006 Dec 7.
- Background: PubMed 18460341Arner P, Pettersson A, Mitchell PJ, Dunbar JD, Kharitonenkov A, Ryden M. FGF21 attenuates lipolysis in human adipocytes - a possible link to improved insulin sensitivity. FEBS Lett. 2008 May 28;582(12):1725-30. doi: 10.1016/j.febslet.2008.04.038. Epub 2008 May 5.
- Background: PubMed 17550778Badman MK, Pissios P, Kennedy AR, Koukos G, Flier JS, Maratos-Flier E. Hepatic fibroblast growth factor 21 is regulated by PPARalpha and is a key mediator of hepatic lipid metabolism in ketotic states. Cell Metab. 2007 Jun;5(6):426-37. doi: 10.1016/j.cmet.2007.05.002.
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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.
Lauren Sparks, 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?
A study testing Exercise in people with Obesity and Disorder of Lipid Storage and Metabolism, 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 15 inclusion and 38 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: under way, not looking for participants, 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?
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?
Measure change in mitochondrial capacity (time frame: Baseline (Day -6), Day 18). 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 NCT01911091, which also lists 82 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.