NCT03697928

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

October 3, 2018

Last Update Submit

October 13, 2020

Conditions

Metabolism and Nutrition DisorderMetabolic Disturbance

Keywords

Acetylcarnitine kineticPhosphocreatine (PCr) kinetic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Skeletal muscle acetylcarnitine recovery after one-legged exercise and carnitine acetyltransferase (CrAT) protein content/activity

    MRS+Exercise test day 2

  • Skeletal muscle CrAT protein activity, from muscle biopsy, and PCr breakdown rate during one-legged exercise

    MRS+Exercise test day 1

  • Skeletal muscle acetylcarnitine formation capacity upon exercise and total carnitine availability in skeletal muscle

    MRS+Exercise test day 2

  • Skeletal muscle mitochondrial function in vitro

    MRS+Exercise test day 2

  • Skeletal muscle oxygen availability

    MRS test day 1

Study Arms (1)

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

Other: Exercise metabolism

Interventions

Exercise metabolismOTHER

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

CrAT subjects

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 37340318DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

muscle biopsies

MeSH Terms

Conditions

Nutrition DisordersPathologic Complete Response

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vera Schrauwen-Hinderling, Phd

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 5, 2018

Study Start

March 12, 2019

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

NL(1)