Regulation of Metabolism and Ion Handling

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317704
• Other study ID #: SET-NAC
• Status: Completed
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: May 20, 2020

Study information

• Verified date: September 2020
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 20, 2020
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Speed endurance training
Speed endurance training

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Morten Hostrup, PhD

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Femoral venous plasma K+	Femoral venous plasma K+ in mmol/L during knee-extensor exercise	Change from before (baseline) to after 6 weeks of training (Week 6)
Other	Femoral venous lactate	Femoral venous lactate in mmol/L during knee-extensor exercise	Change from before (baseline) to after 6 weeks of training (Week 6)
Other	Muscle Na+/K+-ATPase subunit content	Muscle Na+/K+-ATPase subunit content from vastus lateralis biopsies	Change from before (baseline) to after 6 weeks of training (Week 6)
Other	Muscle mitochondrial respiration	Muscle mitochondrial respiration by high resolution respirometry (flux per mg muscle) from vastus lateralis biopsies	Change from before (baseline) to after 6 weeks of training (Week 6)
Other	Muscle mitochondrial content	Muscle mitochondrial content of citrate synthase from vastus lateralis biopsies	Change from before (baseline) to after 6 weeks of training (Week 6)
Primary	Quadriceps endurance	Time to exhaustion during knee-extensor exercise	Change from before (baseline) to after 6 weeks of training (Week 6)
Secondary	K+ release	Net leg K+ release in mmol/min during knee-extensor exercise	Change from before (baseline) to after 6 weeks of training (Week 6)