Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)MITAPNCT07925944
Subgrouping Patients With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Linking the Powerhouses of Cells to the Autonomic Nervous System
A study testing Exercise test and Active standing test in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The goal of this study is to investigate whether mitochondrial dysfunction is present in patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) by subgrouping them into autonomic phenotypes. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
- What is being tested?
- Exercise test and Active standing test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Oct 2024to 1 May 2027
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 70
- Speak Dutch
- ME/CFS syndrome (confirmed by a medical diagnosis)
- Healthy individuals wishing to participate must be currently pain-free and healthy (i.e., participants must not be ill during the period of study participation)
Who cannot join
- Pregnant women or women who were pregnant in the past year
- Persons with a chronic illness such as a rheumatological, endocrine, neurological or psychiatric condition
- Persons with a history of cancer or heart disease
- Persons taking medications that affect the autonomic nervous system such as beta blockers
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel
Jette, 1090
About this study
Official title: Mitochondrial Dysfunction in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Are Autonomic Phenotypes Necessary to Clear Conflicting Results?
The goal of this study is to investigate whether mitochondrial dysfunction is present in patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) by subgrouping them into autonomic phenotypes. The main questions it aims to answer are:
- When patients with ME/CFS are exposed to situations stressing the mitochondria and autonomic nervous system, is the response of their mitochondria and autonomic nervous system dependent on to which autonomic profile the patients belong?
- Is the presence of mitochondrial dysfunction dependent on to which autonomic profile a patient with ME/CFS belongs? Researchers will compare healthy control subjects because very little is known about the link between mitochondria and the autonomic nervous system. It is therefore important that this is also investigated in healthy control subjects to gain a better understanding of which biological changes are normal and which changes may be involved in the symptoms of patients with ME/CFS.
Read more
Participants will:
- Undergo an exercise test (to stress the mitochondria) and an orthostatic test (to stress the autonomic nervous system)
- Fill in questionnaires
- Undergo blood collection
Read the detailed description
ME/CFS is a debilitating disease with unknown pathophysiology. Mitochondrial dysfunction has been proposed as a potential pathophysiological mechanism because the mitochondria are important for energy metabolism. Moreover, patients with mitochondrial diseases experience similar symptoms as patients with ME/CFS, including fatigue, pain and autonomic symptoms. However, literature reports conflicting results regarding mitochondrial dysfunction in patients with ME/CFS. As ME/CFS patients present with a broad range of symptoms, subgrouping them might provide new insights.
Next to mitochondrial dysfunction, the involvement of the autonomic nervous system (ANS) has been proposed as it can be linked to common symptoms such as autonomic symptoms, post-exertional malaise (PEM) and cognitive impairments. Recently, ME/CFS patients were subgrouped into autonomic phenotypes. The presence of autonomic symptoms in patients with mitochondrial diseases highlights that there is a link between the mitochondria and ANS. Although the nature of this link remains unclear, a recent animal study showed that activation of adrenergic receptors - the binding sites of catecholamines (i.e. messengers of the ANS) - increased the production of reactive oxidative species, which are in turn known to influence autonomic function, damage the mitochondria, and regulate mitochondrial DNA methyltransferase (DNMT) expression. Mitochondrial DNMTs are responsible for mtDNA methylation (mtDNAm), which directly affects mitochondrial gene expression and could thus have a major impact on mitochondrial function. Interestingly, Buyn et al. reported that heart rate variability, an important marker to subgroup patients with ME/CFS into autonomic phenotypes, was associated with mtDNAm in a study investigating air pollution in 48 healthy males.
This raises the question whether mitochondrial dysfunction in patients with ME/CFS depends on to which autonomic phenotype they belong and whether this relation can be explained by mtDNAm, which is influenced by reactive oxygen species production upon adrenergic receptor activation. Consequently, this relation may lead to autonomic phenotype-dependent mitochondrial dysfunction. Hence, this project entails a cross-over study designed to clear the conflicting results regarding mitochondrial dysfunction in patients with ME/CFS by subgrouping them into autonomic phenotypes.
The investigators will perform an experimental cross-over study, in which the autonomic phenotypes will be validated and linked to additional biological information (i.e., mitochondrial (dys)function and mitochondrial DNA methylation). Study participants will visit the hospital twice with two weeks in between the visits. During each visit, autonomic, clinical and biological outcomes will be assessed before and after the experimental procedure, which include a single bout of submaximal exercise (Aerobic Power Index) to create a high-energy demand situation and stress the mitochondria, and an orthostatic test (Active Standing test) to stress the autonomic nervous system (ANS). The order of these experimental procedures is defined by randomly dividing all participants into two groups. Additionally, this project will assess the presence and severity of post-exertional malaise (PEM) 24h and 7 days after the experimental procedure via online assessments allowing the investigators to determine whether autonomic phenotype and mitochondrial function can predict PEM severity.
- Being tested
- Exercise test, Active standing test
- Keywords
- Mitochondrial function, Autonomic Nervous System, Epigenetics, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise testOther
Also called Aerobic Power Index
The Aerobic Power Index (API) will be used to create a high-energy demand situation and stress the mitochondria. Briefly, cycling starts at a constant rate of 70 cycles/min and workload of 25 Watt/min, increasing 25 Watt/min until the patient reaches 75% of the age-predicted maximal heart rate.
Active standing testOther
Also called orthostatic test
The ANS will be stressed via an Active Standing (AS) test, an ecological valid orthostatic test. Subjects will start in a supine position followed by standing up within five seconds, these instructions will be explained to the subjects prior to the start of the AS test. After standing up, the subjects need to maintain an upright posture quietly for seven minutes, afterwards the patients will be returned to the supine position.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Experimental | Study participants will visit the hospital twice with two weeks in between the visits. During each visit, autonomic, clinical and biological outcomes will be assessed before and after the experimental procedure, which include a single bout of submaximal exercise (Aerobic Power Index) to create a high-energy demand situation and stress the mitochondria, and an orthostatic test (Active Standing test) to stress the autonomic nervous system (ANS). The order of these experimental procedures is defined by randomly dividing all participants into two groups. Additionally, this project will assess the presence and severity of post-exertional malaise (PEM) 24h and 7 days after the experimental procedure via online assessments allowing us to determine whether autonomic phenotype and mitochondrial function can predict PEM severity. Receives: Other: Exercise test; Other: Active standing test |
| ME/CFS patients | Experimental | Study participants will visit the hospital twice with two weeks in between the visits. During each visit, autonomic, clinical and biological outcomes will be assessed before and after the experimental procedure, which include a single bout of submaximal exercise (Aerobic Power Index) to create a high-energy demand situation and stress the mitochondria, and an orthostatic test (Active Standing test) to stress the autonomic nervous system (ANS). The order of these experimental procedures is defined by randomly dividing all participants into two groups. Additionally, this project will assess the presence and severity of post-exertional malaise (PEM) 24h and 7 days after the experimental procedure via online assessments allowing us to determine whether autonomic phenotype and mitochondrial function can predict PEM severity. Receives: Other: Exercise test; Other: Active standing test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial function will be investigated in patients with ME/CFS compaired to healthy controls at baseline and after a physical exercise test.
The primary objective is to examine the difference in mitochondrial function between 75 ME/CFS patients and 30 healthy controls. Mitochondrial function will be determined in isolated peripheral blood mononuclear cells (PBMCs). Following the manufacturer's instructions, the Seahorse XF Cell Mito Stress Test Kit (Agilent) will be used to determine the oxygen consumption rate (OCR).
Measured: Blood collection immediatly before procedure and after
Autonomic nervous system (ANS) function will be explored in patients with ME/CFS and healthy controls at baseline and after an orthostatic test.
The investigators will explore autonomc nervous system (ANS) function, enabling clinical stratification of 75 patients with ME/CFS. During the othostatic test or active standing test, the ANS will be monitored with the SOMNOTouch NIBP device, providing a non-invasive continuous blood pressure monitoring.
Measured: During intervention (approximately 45 mins) in hospital
Autonomic nervous system (ANS) function will be explored in patients with ME/CFS and healthy controls at baseline and after an orthostatic test.
The investigators will explore autonomc nervous system (ANS) function, enabling clinical stratification of 75 patients with ME/CFS. During the othostatic test or active standing test, the ANS will be monitored with the SOMNOTouch NIBP device, providing a non-invasive continuous heart rate monitoring.
Measured: During intervention (approximately 45 mins) in hospital
Autonomic nervous system (ANS) function will be explored in patients with ME/CFS and healthy controls at baseline and after an orthostatic test.
The investigators will explore autonomc nervous system (ANS) function, enabling clinical stratification of 75 patients with ME/CFS. During the othostatic test or active standing test, the ANS will be monitored with the SOMNOTouch NIBP device, providing a non-invasive continuous arterial stiffness measurement.
Measured: During intervention (approximately 45 mins) in hospital
Secondary outcomes (2)
Prediction of severity of post-exertional malaise in patients with ME/CFS.
Prediction of the severity of early- (24h) post-exertional malaise (PEM) in 75 patients with ME/CFS via online assessments including the Chronic Fatigue Syndrome Symptom List.
Measured: 24hours after both study visits
Prediction of severity of post-exertional malaise in patients with ME/CFS.
Prediction of the severity of late-onset (7 days) PEM in 75 patients with ME/CFS via online assessments including the Quality of Life Scale (quality of life, health and other areas of life, min score = not at all, max score=absolutely), Fatigue Severity Scale (min score 0=strongly disagree, max score 6=strongly agree), International Physical Activity Questionnaire and Chronic Fatigue Syndrome Symptom List.
Measured: 7 days after both study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start21 Oct 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)Studies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jente Van Campenhout, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07925944
- Sponsor's protocol ID
- EC-2023-391
- Acronym
- MITAP
- Status last verified
- Nov 2026
- First submitted
- 18 Jul 2024
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Dysfunction in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Are Autonomic Phenotypes Necessary to Clear Conflicting Results?
- ClinicalTrials.gov ID
- NCT07925944
- Acronym / sponsor ID
- MITAP / EC-2023-391
- Keywords
- Mitochondrial function, Autonomic Nervous System, Epigenetics, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 9 Nov 2026 (actual)
- 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 goal of this study is to investigate whether mitochondrial dysfunction is present in patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) by subgrouping them into autonomic phenotypes. The main questions it aims to answer are:
- When patients with ME/CFS are exposed to situations stressing the mitochondria and autonomic nervous system, is the response of their mitochondria and autonomic nervous system dependent on to which autonomic profile the patients belong?
- Is the presence of mitochondrial dysfunction dependent on to which autonomic profile a patient with ME/CFS belongs? Researchers will compare healthy control subjects because very little is known about the link between mitochondria and the autonomic nervous system. It is therefore important that this is also investigated in healthy control subjects to gain a better understanding of which biological changes are normal and which changes may be involved in the symptoms of patients with ME/CFS.
Participants will:
- Undergo an exercise test (to stress the mitochondria) and an orthostatic test (to stress the autonomic nervous system)
- Fill in questionnaires
- Undergo blood collection
Detailed description
ME/CFS is a debilitating disease with unknown pathophysiology. Mitochondrial dysfunction has been proposed as a potential pathophysiological mechanism because the mitochondria are important for energy metabolism. Moreover, patients with mitochondrial diseases experience similar symptoms as patients with ME/CFS, including fatigue, pain and autonomic symptoms. However, literature reports conflicting results regarding mitochondrial dysfunction in patients with ME/CFS. As ME/CFS patients present with a broad range of symptoms, subgrouping them might provide new insights.
Next to mitochondrial dysfunction, the involvement of the autonomic nervous system (ANS) has been proposed as it can be linked to common symptoms such as autonomic symptoms, post-exertional malaise (PEM) and cognitive impairments. Recently, ME/CFS patients were subgrouped into autonomic phenotypes. The presence of autonomic symptoms in patients with mitochondrial diseases highlights that there is a link between the mitochondria and ANS. Although the nature of this link remains unclear, a recent animal study showed that activation of adrenergic receptors - the binding sites of catecholamines (i.e. messengers of the ANS) - increased the production of reactive oxidative species, which are in turn known to influence autonomic function, damage the mitochondria, and regulate mitochondrial DNA methyltransferase (DNMT) expression. Mitochondrial DNMTs are responsible for mtDNA methylation (mtDNAm), which directly affects mitochondrial gene expression and could thus have a major impact on mitochondrial function. Interestingly, Buyn et al. reported that heart rate variability, an important marker to subgroup patients with ME/CFS into autonomic phenotypes, was associated with mtDNAm in a study investigating air pollution in 48 healthy males.
This raises the question whether mitochondrial dysfunction in patients with ME/CFS depends on to which autonomic phenotype they belong and whether this relation can be explained by mtDNAm, which is influenced by reactive oxygen species production upon adrenergic receptor activation. Consequently, this relation may lead to autonomic phenotype-dependent mitochondrial dysfunction. Hence, this project entails a cross-over study designed to clear the conflicting results regarding mitochondrial dysfunction in patients with ME/CFS by subgrouping them into autonomic phenotypes.
The investigators will perform an experimental cross-over study, in which the autonomic phenotypes will be validated and linked to additional biological information (i.e., mitochondrial (dys)function and mitochondrial DNA methylation). Study participants will visit the hospital twice with two weeks in between the visits. During each visit, autonomic, clinical and biological outcomes will be assessed before and after the experimental procedure, which include a single bout of submaximal exercise (Aerobic Power Index) to create a high-energy demand situation and stress the mitochondria, and an orthostatic test (Active Standing test) to stress the autonomic nervous system (ANS). The order of these experimental procedures is defined by randomly dividing all participants into two groups. Additionally, this project will assess the presence and severity of post-exertional malaise (PEM) 24h and 7 days after the experimental procedure via online assessments allowing the investigators to determine whether autonomic phenotype and mitochondrial function can predict PEM severity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Experimental | Other: Exercise test, Other: Active standing testStudy participants will visit the hospital twice with two weeks in between the visits. During each visit, autonomic, clinical and biological outcomes will be assessed before and after the experimental procedure, which include a single bout of submaximal exercise (Aerobic Power Index) to create a high-energy demand situation and stress the mitochondria, and an orthostatic test (Active Standing test) to stress the autonomic nervous system (ANS). The order of these experimental procedures is defined by randomly dividing all participants into two groups. Additionally, this project will assess the presence and severity of post-exertional malaise (PEM) 24h and 7 days after the experimental procedure via online assessments allowing us to determine whether autonomic phenotype and mitochondrial function can predict PEM severity. |
| ME/CFS patients | Experimental | Other: Exercise test, Other: Active standing testStudy participants will visit the hospital twice with two weeks in between the visits. During each visit, autonomic, clinical and biological outcomes will be assessed before and after the experimental procedure, which include a single bout of submaximal exercise (Aerobic Power Index) to create a high-energy demand situation and stress the mitochondria, and an orthostatic test (Active Standing test) to stress the autonomic nervous system (ANS). The order of these experimental procedures is defined by randomly dividing all participants into two groups. Additionally, this project will assess the presence and severity of post-exertional malaise (PEM) 24h and 7 days after the experimental procedure via online assessments allowing us to determine whether autonomic phenotype and mitochondrial function can predict PEM severity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 18 and 70
- Speak Dutch
- ME/CFS syndrome (confirmed by a medical diagnosis)
- Healthy individuals wishing to participate must be currently pain-free and healthy (i.e., participants must not be ill during the period of study participation)
Key exclusion criteria (4 listed)
- Pregnant women or women who were pregnant in the past year
- Persons with a chronic illness such as a rheumatological, endocrine, neurological or psychiatric condition
- Persons with a history of cancer or heart disease
- Persons taking medications that affect the autonomic nervous system such as beta blockers
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 |
|---|---|---|
| Exercise testAlso: Aerobic Power IndexThe Aerobic Power Index (API) will be used to create a high-energy demand situation and stress the mitochondria. Briefly, cycling starts at a constant rate of 70 cycles/min and workload of 25 Watt/min, increasing 25 Watt/min until the patient reaches 75% of the age-predicted maximal heart rate. | Other | Healthy controls, ME/CFS patients |
| Active standing testAlso: orthostatic testThe ANS will be stressed via an Active Standing (AS) test, an ecological valid orthostatic test. Subjects will start in a supine position followed by standing up within five seconds, these instructions will be explained to the subjects prior to the start of the AS test. After standing up, the subjects need to maintain an upright posture quietly for seven minutes, afterwards the patients will be returned to the supine position. | Other | Healthy controls, ME/CFS patients |
Primary outcome
Mitochondrial function will be investigated in patients with ME/CFS compaired to healthy controls at baseline and after a physical exercise test.
Time frame: Blood collection immediatly before procedure and after
The primary objective is to examine the difference in mitochondrial function between 75 ME/CFS patients and 30 healthy controls. Mitochondrial function will be determined in isolated peripheral blood mononuclear cells (PBMCs). Following the manufacturer's instructions, the Seahorse XF Cell Mito Stress Test Kit (Agilent) will be used to determine the oxygen consumption rate (OCR).
Autonomic nervous system (ANS) function will be explored in patients with ME/CFS and healthy controls at baseline and after an orthostatic test.
Time frame: During intervention (approximately 45 mins) in hospital
The investigators will explore autonomc nervous system (ANS) function, enabling clinical stratification of 75 patients with ME/CFS. During the othostatic test or active standing test, the ANS will be monitored with the SOMNOTouch NIBP device, providing a non-invasive continuous blood pressure monitoring.
Autonomic nervous system (ANS) function will be explored in patients with ME/CFS and healthy controls at baseline and after an orthostatic test.
Time frame: During intervention (approximately 45 mins) in hospital
The investigators will explore autonomc nervous system (ANS) function, enabling clinical stratification of 75 patients with ME/CFS. During the othostatic test or active standing test, the ANS will be monitored with the SOMNOTouch NIBP device, providing a non-invasive continuous heart rate monitoring.
Autonomic nervous system (ANS) function will be explored in patients with ME/CFS and healthy controls at baseline and after an orthostatic test.
Time frame: During intervention (approximately 45 mins) in hospital
The investigators will explore autonomc nervous system (ANS) function, enabling clinical stratification of 75 patients with ME/CFS. During the othostatic test or active standing test, the ANS will be monitored with the SOMNOTouch NIBP device, providing a non-invasive continuous arterial stiffness measurement.
2 secondary outcomes
Prediction of severity of post-exertional malaise in patients with ME/CFS.
Time frame: 24hours after both study visits
Prediction of severity of post-exertional malaise in patients with ME/CFS.
Time frame: 7 days after both study visits
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 9 Nov 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 test and Active standing test in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), run by Vrije Universiteit Brussel at 1 site in Belgium.
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 4 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 9 Nov 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 Belgium. 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?
Mitochondrial function will be investigated in patients with ME/CFS compaired to healthy controls at baseline and after a physical exercise test. (time frame: Blood collection immediatly before procedure and after). The study lists 4 primary outcomes in all. 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 9 Nov 2026.