Metabolism and Nutrition DisorderNCT03697928
Markers of Carnitine Acetyltransferase (CrAT) Protein Activity and Carnitine Availability
An observational study of Metabolism and Nutrition Disorder and Metabolic Disturbance, run by Maastricht University at 1 site in Netherlands.
Trial summary
This study aims to measure skeletal muscle metabolism in vivo during exercise using the non-invasive Magnetic Resonance Spectroscopy (MRS) technique. Specifically, phosphocreatine (PCr) kinetic and Acetylcarnitine levels will be determined at resting, during exercise and during the recovery post exercise. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolism and Nutrition Disorder, Metabolic Disturbance
- What is being tested?
- Exercise metabolism
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Mar 2019to 1 Feb 2020
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: In this study, 13 healthy young males (BMI <25 kg/m2), aged 18-40yr with different maximal aerobic capacity will be included. Specifically, 4 volunteers with a VO2max <40 ml/kg/min, 5 volunteers with a VO2max between 41 and 50 ml/kg/min and 4 volunteers with a VO2max >50 ml/kg/min will be included.
Who may be able to join
- Males, Generally healthy
- Age 18-40 years old
- BMI 18 - 25 kg/m2
- No medication use that interfere with the aims of the study
- Stable level of daily physical activity or training for at least 6 months
Who cannot join
- Females
- Regular smokers, drug abuse
- Participation in other studies
- Weight gain/loss > 3 kg in the last 6 months
- Contraindications for MRS scans:
- Vegetarian eating behavior
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Searching for Non-invasive Magnetic Resonance-based Markers for CrAT Protein Activity and Carnitine Availability in Skeletal Muscle
This study aims to measure skeletal muscle metabolism in vivo during exercise using the non-invasive Magnetic Resonance Spectroscopy (MRS) technique. Specifically, phosphocreatine (PCr) kinetic and Acetylcarnitine levels will be determined at resting, during exercise and during the recovery post exercise. The target population is adult healthy men, with a wide range of maximal physical capacity.
Read the detailed description
Skeletal muscle mitochondrial activation during the transition from resting metabolism to exercise may modulated by CrAT activity. Furthermore, dynamic changes in acetylcarnitine during the transition from exercise to resting metabolism (acetylcarnitine off-kinetic) may also reflect the action of CrAT protein. To date, the only possibility to get information on CrAT activity is by taking a muscle biopsy and perform enzyme activity assays ex vivo. By dynamic MRS scanning, it might be possible to deduce information that reflects CrAT activity, thereby making the biopsy sampling unnecessary.
- Being tested
- Exercise metabolism
- Keywords
- Acetylcarnitine kinetic, Phosphocreatine (PCr) kinetic
- Medical subject headings
- Nutrition Disorders, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise metabolismOther
Participants will perform a series of exercises inside and outside the MRS/MRI scanner.
| Study group | Role | What they receive |
|---|---|---|
| CrAT subjects | 13 healthy adult men, with a wide range of maximal aerobic capacity will be included.
Subjects will be classified as trained, physical active and untrained according to their VO2max.
Subject will perform one-legged knee extension and flexion exercise inside the MRS scanner and cycling outside the scanner Receives: Other: Exercise metabolism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle PCr on-kinetic during exercise and carnitine acetyltransferase (CrAT) protein content/activity
The correlation between skeletal muscle PCr on-kinetic during one-legged exercise and CrAT protein activity will be determined.
Measured: MRS+Exercise test day 2
Secondary outcomes (5)
Skeletal muscle acetylcarnitine recovery after one-legged exercise and carnitine acetyltransferase (CrAT) protein content/activity
The correlation between skeletal muscle acetylcarnitine off-kinetic after one-legged exercise and CrAT protein activity will be determined.
Measured: MRS+Exercise test day 2
Skeletal muscle CrAT protein activity, from muscle biopsy, and PCr breakdown rate during one-legged exercise
The correlation between CrAT protein activity and PCr hydrolysis/breakdown will be determined
Measured: MRS+Exercise test day 1
Skeletal muscle acetylcarnitine formation capacity upon exercise and total carnitine availability in skeletal muscle
The correlation between acetylcarnitine formation upon exercise and total carnitine availability will be determined
Measured: MRS+Exercise test day 2
Skeletal muscle mitochondrial function in vitro
The association between Skeletal muscle mitochondrial function in vitro and in vivo
Measured: MRS+Exercise test day 2
Skeletal muscle oxygen availability
in vivo assessment of oxygen availability in muscle tissue upon hypoxic stimulus during resting
Measured: MRS test day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start12 Mar 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolism and Nutrition DisorderStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vera Schrauwen-Hinderling, Phd, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697928
- Sponsor's protocol ID
- NL63005.068.18
- Status last verified
- Oct 2020
- First submitted
- 3 Oct 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mancilla R, Pava-Mejia D, van Polanen N, de Wit V, Bergman M, Grevendonk L, Jorgensen J, Kornips E, Hoeks J, Hesselink MKC, Schrauwen-Hinderling VB. Invasive and noninvasive markers of human skeletal muscle mitochondrial function. Physiol Rep. 2023 Jun;11(12):e15734. doi: 10.14814/phy2.15734.
PubMed 37340318
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Searching for Non-invasive Magnetic Resonance-based Markers for CrAT Protein Activity and Carnitine Availability in Skeletal Muscle
- ClinicalTrials.gov ID
- NCT03697928
- Acronym / sponsor ID
- NL63005.068.18
- Keywords
- Acetylcarnitine kinetic, Phosphocreatine (PCr) kinetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 5 Oct 2018 (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.
This study aims to measure skeletal muscle metabolism in vivo during exercise using the non-invasive Magnetic Resonance Spectroscopy (MRS) technique. Specifically, phosphocreatine (PCr) kinetic and Acetylcarnitine levels will be determined at resting, during exercise and during the recovery post exercise. The target population is adult healthy men, with a wide range of maximal physical capacity.
Detailed description
Skeletal muscle mitochondrial activation during the transition from resting metabolism to exercise may modulated by CrAT activity. Furthermore, dynamic changes in acetylcarnitine during the transition from exercise to resting metabolism (acetylcarnitine off-kinetic) may also reflect the action of CrAT protein. To date, the only possibility to get information on CrAT activity is by taking a muscle biopsy and perform enzyme activity assays ex vivo. By dynamic MRS scanning, it might be possible to deduce information that reflects CrAT activity, thereby making the biopsy sampling unnecessary.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CrAT subjects | – | Other: Exercise metabolism13 healthy adult men, with a wide range of maximal aerobic capacity will be included. Subjects will be classified as trained, physical active and untrained according to their VO2max. Subject will perform one-legged knee extension and flexion exercise inside the MRS scanner and cycling outside the scanner |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In this study, 13 healthy young males (BMI <25 kg/m2), aged 18-40yr with different maximal aerobic capacity will be included. Specifically, 4 volunteers with a VO2max <40 ml/kg/min, 5 volunteers with a VO2max between 41 and 50 ml/kg/min and 4 volunteers with a VO2max >50 ml/kg/min will be included.
Key inclusion criteria (5 listed)
- Males, Generally healthy
- Age 18-40 years old
- BMI 18 - 25 kg/m2
- No medication use that interfere with the aims of the study
- Stable level of daily physical activity or training for at least 6 months
Key exclusion criteria (6 listed)
- Females
- Regular smokers, drug abuse
- Participation in other studies
- Weight gain/loss > 3 kg in the last 6 months
- Contraindications for MRS scans:
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 metabolismParticipants will perform a series of exercises inside and outside the MRS/MRI scanner. | Other | CrAT subjects |
Primary outcome
Skeletal muscle PCr on-kinetic during exercise and carnitine acetyltransferase (CrAT) protein content/activity
Time frame: MRS+Exercise test day 2
The correlation between skeletal muscle PCr on-kinetic during one-legged exercise and CrAT protein activity will be determined.
5 secondary outcomes
Skeletal muscle acetylcarnitine recovery after one-legged exercise and carnitine acetyltransferase (CrAT) protein content/activity
Time frame: MRS+Exercise test day 2
Skeletal muscle CrAT protein activity, from muscle biopsy, and PCr breakdown rate during one-legged exercise
Time frame: MRS+Exercise test day 1
Skeletal muscle acetylcarnitine formation capacity upon exercise and total carnitine availability in skeletal muscle
Time frame: MRS+Exercise test day 2
Skeletal muscle mitochondrial function in vitro
Time frame: MRS+Exercise test day 2
Skeletal muscle oxygen availability
Time frame: MRS test day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 37340318Mancilla R, Pava-Mejia D, van Polanen N, de Wit V, Bergman M, Grevendonk L, Jorgensen J, Kornips E, Hoeks J, Hesselink MKC, Schrauwen-Hinderling VB. Invasive and noninvasive markers of human skeletal muscle mitochondrial function. Physiol Rep. 2023 Jun;11(12):e15734. doi: 10.14814/phy2.15734.
- Individual participant dataSharing planned: Undecided
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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.
Vera Schrauwen-Hinderling, Phd principal investigator
Maastricht University
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 Metabolism and Nutrition Disorder and Metabolic Disturbance, run by Maastricht University at 1 site in Netherlands.
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 5 inclusion and 6 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 19 Oct 2020. 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 Netherlands. 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?
Skeletal muscle PCr on-kinetic during exercise and carnitine acetyltransferase (CrAT) protein content/activity (time frame: MRS+Exercise test day 2). 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 NCT03697928, which also lists 1 linked publication.
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 19 Oct 2020.