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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.

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).

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000546550
Enrollment
40
Registered
2024-04-30
Start date
2024-05-31
Completion date
2024-06-30
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The main aim of the study will be to evaluate the effect of a single dose of NAC on the balance of prooxidant/antioxidant balance, intestinal barrier permeability and markers of damage to skeletal muscle damage in subjects performing exercise with predominantly eccentric contractions (long distance runners). The research hypothesis assumes a reduction in the permeability of the intestinal barrier, skeletal muscle damage and improvement of antioxidant capacity after NAC supplementation compared to the placebo group.

Interventions

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 echocar

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.

Sponsors

University of Physical Education in Katowice
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026