Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000546550
Ethics application status
Approved
Date submitted
8/01/2024
Date registered
30/04/2024
Date last updated
30/04/2024
Date data sharing statement initially provided
30/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute effect of a single dose of N-acetylcysteine (NAC) on prooxidant/antioxidant balance, intestinal barrier permeability and markers of skeletal muscle damage in physically active men.
Scientific title
Acute effect of a single dose of N-acetylcysteine (NAC) on prooxidant/antioxidant balance, intestinal barrier permeability and markers of skeletal muscle damage in physically active men (amateur long distance runners).
Secondary ID [1] 311262 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxidative stress 332484 0
Inflammation 332485 0
Muscle damage 332486 0
Condition category
Condition code
Inflammatory and Immune System 329176 329176 0 0
Normal development and function of the immune system
Blood 329177 329177 0 0
Normal development and function of platelets and erythrocytes
Oral and Gastrointestinal 329178 329178 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is controlled, double-blind, parallel intervention trial in healthy men (amateur long distance runners). The purpose of this intervention is to evaluate the effect of a single dose (600 mg) of N-acetylcysteine (NAC) on prooxidant/antioxidant balance, intestinal barrier permeability and markers of skeletal muscle damage.

The study will be carried out in four stages:
Stage I
In the first stage, blood will be drawn in all subjects at rest to assess blood coagulation indices. An echocardiogram will also be performed to assess acquired and/or congenital heart defects. If symptoms suggestive of blood clotting abnormalities and/or heart defects are confirmed by the physician caring for the subjects, such subjects will be excluded from the study. The process and results will be assessed by a medical doctor and nurse.
Subjects who meet the inclusion criteria will undergo an assessment of anthropometric indices using the InBody Data Management System and will be subjected to a nutritional analysis using food diaries and the Diet 6 computer software. The process and results will be assessed by a nutritionist.
Subsequently, the subjects will perform a running test with gradually increasing load on a moving treadmill (Cosmed, Germany) to assess aerobic capacity. During the test, the running speed will be increased by 2km/h every 3 min until a running speed of 14 km/h is reached, and then the angle of the treadmill to the ground will be increased by 2.5º until the body's maximum muscle workload is reached individually. During the run, continuous measurement of oxygen uptake will be carried out using a gas analyser (Oxycon, Jaeger, Germany), heart rate will be measured using a Polar-3500PE sports-tester (Finland). Blood lactate concentration will be measured by enzyme-amperometry using an analyser from EKF Biosen C-Line. The process and results will be assessed by a medical doctor and nurse. The interval between the first and second stage will be at least 7 days.
The approximate time taken for stage 1 is 1,5h for each subject.

Stage II
The subjects will perform a 60-minute running test on a treadmill with an incline angle of -10º (this type of exercise induces eccentric muscle contractions and causes muscle microtrauma and fatigue) at 60% of their individually determined VO2max. Blood for the study will be collected before the start of the exercise test, 3 min post-exercise, at 1 h and 24 h post-exercise restitution. The total blood volume will be: approximately 21 ml. The process and results will be assessed by a medical doctor and nurse.
The approximate time taken for stage 2 is 2h for each subject.

Stage III
At least 3 weeks rest period.

Stage IV
In the fourth stage, the subjects will be randomly allocated to two groups: consuming NAC or placebo. One hour after taking a dose of NAC or placebo, they will perform a 60-minute running test on a -10º treadmill at 60% of their VO2max. Blood for biochemical testing will be collected 4 times i.e. before the start of the exercise test, 3-5 min after the end of the test, at 1 h post-exercise restitution and 24 h post-exercise. The total blood volume will be 21 ml.
NAC will be administered by oral tablet by nurse.
To assess compliance with the intervention, NAC or placebo will be administered to subjects one hour before the exercise test. Subjects will consume NAC or placebo in the presence of a nurse.
The process and results will be assessed by a medical doctor and nurse. The approximate time taken for stage 4 is 4h for each subject.
Intervention code [1] 327716 0
Treatment: Drugs
Comparator / control treatment
The placebo group participants received identical capsules but with different contents. According to the information from manufacturer, the contents of the placebo capsule are: filler - microcrystalline cellulose, capsule (gelatin, E171 dye), anti-caking agent - magnesium salts of fatty acids, silicon dioxide. The dose of placebo was the same as when using the supplement.
Control group
Placebo

Outcomes
Primary outcome [1] 337046 0
Activity of antioxidant enzyme - SOD.
Timepoint [1] 337046 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Primary outcome [2] 337047 0
Indicator of intestinal permeability: fatty acid binding protein (I-FABP)
Timepoint [2] 337047 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Primary outcome [3] 337048 0
Muscle damage marker activity - CK
Timepoint [3] 337048 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [1] 430467 0
Blood morphology - haemoglobin
Timepoint [1] 430467 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [2] 430468 0
Inflammatory marker - TNF-alpha
Timepoint [2] 430468 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [3] 430469 0
Markers of oxidative stress - 8-OHdG
Timepoint [3] 430469 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [4] 430470 0
Brain-derived neurotrophic factor (BDNF)
Timepoint [4] 430470 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [5] 434007 0
Activity of antioxidant enzyme - GPx.
Timepoint [5] 434007 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [6] 434008 0
Activity of antioxidant enzyme - GR
Timepoint [6] 434008 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [7] 434009 0
Activity of antioxidant enzyme - CAT
Timepoint [7] 434009 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [8] 434010 0
Activity of antioxidant enzyme - TAS
Timepoint [8] 434010 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [9] 434011 0
Activity of antioxidant enzyme – PerOx
Timepoint [9] 434011 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [10] 434012 0
Indicator of intestinal permeability: zonulin.
Timepoint [10] 434012 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [11] 434013 0
Muscle damage marker activity - LDH
Timepoint [11] 434013 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [12] 434014 0
Liver marker activity - AST
Timepoint [12] 434014 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [13] 434015 0
Liver marker activity - ALT
Timepoint [13] 434015 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [14] 434016 0
Liver marker activity - GGT
Timepoint [14] 434016 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [15] 434017 0
Liver marker activity - mioglobin
Timepoint [15] 434017 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [16] 434018 0
Blood morphology - haematocrit
Timepoint [16] 434018 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [17] 434019 0
Blood morphology - red cell indicator
Timepoint [17] 434019 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [18] 434020 0
Inflammatory marker - CRP
Timepoint [18] 434020 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [19] 434021 0
Inflammatory marker - IL-1ß
Timepoint [19] 434021 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [20] 434022 0
Inflammatory markers - IL-6
Timepoint [20] 434022 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [21] 434023 0
Inflammatory markers - IL-10
Timepoint [21] 434023 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [22] 434024 0
Markers of oxidative stress - MDA
Timepoint [22] 434024 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Secondary outcome [23] 434025 0
Markers of oxidative stress - AOPP
Timepoint [23] 434025 0
Stage 2 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.
Stage 4 - before the start of the exercise test, 3 min. after the end of exercise, at 1 h and 24 h post-exercise restitution.

Eligibility
Key inclusion criteria
Selection of individuals for the study will be conditional on meeting the following criteria:
- absence of symptoms suggestive of blood clotting disorders,
- absence of congenital and acquired heart defects confirmed by echocardiography performed at the Academic Medical Centre prior to the study,
- voluntary consent for the examination,
- having a permission to take part in the examination issued by a doctor belonging to the research team,
- experiance of sports training for at least 3 years,
- men of full age, physically active,
- not taking antibiotics, nitroglycerin, nitrates or cough suppressants in the period preceding (at least 2 months) and during the study,
- no sensitivity to any ingredient of the preparation, no diseases, i.e. acute asthma attack, gastric ulcer and/or duodenal ulcer,
- subjects not taking antioxidant supplements and/or anti-inflammatory drugs in the period preceding (at least 2 months) the study and during their implementation.
- no previous injuries in the musculoskeletal system involving the lower limbs.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers are randomly assigned to the groups. Allocation of the participants will be conceal using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated simple randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical analysis will be performed in IBM Statistics 26.0 (IBM Corporation, Ar-monk, NY, USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/05/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 26064 0
Poland
State/province [1] 26064 0
Silesia Poland

Funding & Sponsors
Funding source category [1] 315517 0
University
Name [1] 315517 0
University of Physical Education in Katowice
Country [1] 315517 0
Poland
Primary sponsor type
University
Name
University of Physical Education in Katowice
Address
40-065 Katowice, Mikolowska 72A
Country
Poland
Secondary sponsor category [1] 317601 0
Individual
Name [1] 317601 0
Prof. Ewa Sadowska-Krepa
Address [1] 317601 0
40-065 Katowice, Mikolowska 72A
Country [1] 317601 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314420 0
University Bioethics Committee for Scientific Research at the Academy of Physical Education in Katowice
Ethics committee address [1] 314420 0
Ethics committee country [1] 314420 0
Poland
Date submitted for ethics approval [1] 314420 0
10/07/2023
Approval date [1] 314420 0
19/10/2023
Ethics approval number [1] 314420 0
Certificate no. 4-X/2023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131514 0
Mr Dariusz Ozner
Address 131514 0
University of Physical Education in Katowice, 40-065 Katowice, Mikolowska 72A
Country 131514 0
Poland
Phone 131514 0
+48500277175
Fax 131514 0
Email 131514 0
[email protected]
Contact person for public queries
Name 131515 0
Dariusz Ozner
Address 131515 0
University of Physical Education in Katowice, 40-065 Katowice, Mikolowska 72A
Country 131515 0
Poland
Phone 131515 0
+48500277175
Fax 131515 0
Email 131515 0
[email protected]
Contact person for scientific queries
Name 131516 0
Ewa Sadowska-Krepa
Address 131516 0
University of Physical Education in Katowice, 40-065 Katowice, Mikolowska 72A
Country 131516 0
Poland
Phone 131516 0
+48 32 207 51 47
Fax 131516 0
Email 131516 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.