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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03697928
Other study ID # NL63005.068.18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 12, 2019
Est. completion date February 1, 2020

Study information

Verified date October 2020
Source Maastricht University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The target population is adult healthy men, with a wide range of maximal physical capacity.


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date February 1, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise metabolism
Participants will perform a series of exercises inside and outside the MRS/MRI scanner.

Locations

Country Name City State
Netherlands Maastricht University Maastricht Limburg

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. MRS+Exercise test day 2
Secondary 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. MRS+Exercise test day 2
Secondary 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 MRS+Exercise test day 1
Secondary 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 MRS+Exercise test day 2
Secondary Skeletal muscle mitochondrial function in vitro The association between Skeletal muscle mitochondrial function in vitro and in vivo MRS+Exercise test day 2
Secondary Skeletal muscle oxygen availability in vivo assessment of oxygen availability in muscle tissue upon hypoxic stimulus during resting MRS test day 1
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