Regulation of Metabolism and Ion Handling

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Speed endurance training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: speed endurance training (SET); Training 6 weeks 3 times pr. week	Behavioral: Speed endurance training; Speed endurance training
No Intervention: Controls; Asked to continue their usual life style
Active Comparator: speed endurance training (SET) II; Training 6 weeks 3 times pr. week	Behavioral: Speed endurance training; Speed endurance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps endurance	Time to exhaustion during knee-extensor exercise	Change from before (baseline) to after 6 weeks of training (Week 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Morten Hostrup, PhD

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2017
• Primary Completion (Actual): December 18, 2019
• Study Completion (Actual): May 20, 2020

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SET-NAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No