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Completed

NCT Number: NCT03317704

Regulation of Metabolism and Ion Handling

This study investigates the relation between ion-handling (K+) and fatigue development during exercise. Before and after a 6-week period of high intensity interval training, performance and ion-handling is assessed in young adults. In addition, mitochondrial function is examined.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men
  • 45-55 ml/kg/min
  • BMI 19-26 kg/m2
  • Normal ECG (assessed by MD)

Exclusion criteria

  • Allergic to n-acetylcystine (NAC) or digoxin
  • Severe side effects from NAC or digoxin
  • Chronic diseases (assessed by MD to be a potential hazard or to interfere with outcome measures)

Treatment and study plan

Speed endurance training

Behavioral

Speed endurance training

Primary outcomes

  1. Quadriceps endurance

    Time frame: Change from before (baseline) to after 6 weeks of training (Week 6)

    Time to exhaustion during knee-extensor exercise

Secondary outcomes

  1. K+ release

    Time frame: Change from before (baseline) to after 6 weeks of training (Week 6)

    Net leg K+ release in mmol/min during knee-extensor exercise

Other outcomes

  1. Femoral venous plasma K+

    Time frame: Change from before (baseline) to after 6 weeks of training (Week 6)

    Femoral venous plasma K+ in mmol/L during knee-extensor exercise

  2. Femoral venous lactate

    Time frame: Change from before (baseline) to after 6 weeks of training (Week 6)

    Femoral venous lactate in mmol/L during knee-extensor exercise

  3. Muscle Na+/K+-ATPase subunit content

    Time frame: Change from before (baseline) to after 6 weeks of training (Week 6)

    Muscle Na+/K+-ATPase subunit content from vastus lateralis biopsies

  4. Muscle mitochondrial respiration

    Time frame: Change from before (baseline) to after 6 weeks of training (Week 6)

    Muscle mitochondrial respiration by high resolution respirometry (flux per mg muscle) from vastus lateralis biopsies

  5. Muscle mitochondrial content

    Time frame: Change from before (baseline) to after 6 weeks of training (Week 6)

    Muscle mitochondrial content of citrate synthase from vastus lateralis biopsies

Sponsors and collaborators

Lead sponsor

Morten Hostrup, PhD

Other

Registry information

Official study title

Regulation of Metabolism and Ion Handling - Effect of High Intensity Training and NAC-infusion in Young Men

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 23, 2017
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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