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Assessment of the Impact of N-acetylcysteine Supplementation on Physical Performance

Assessment of the Impact of N-acetylcysteine Supplementation on Physical Performance Depending on the Polymorphism of Genes Related to Glutathione Metabolism

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05604586
Enrollment
77
Registered
2022-11-03
Start date
2022-05-01
Completion date
2025-09-30
Last updated
2026-06-10

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

Conditions

Gene Polymorphisms, Skeletal Muscle Performance

Keywords

Sport performance, gene polymorphism, N-acetylcysteine

Brief summary

Study aims to verify the hypothesis: * N-acetylcysteine (NAC) supplementation improves exercise capacity in people training endurance sports and the effectiveness of this supplementation depends on the polymorphism of genes related to folate and glutathione metabolism. * NAC supplementation affects the parameters of oxidative stress among women and men training endurance disciplines

Detailed description

* Glutathione depletion caused by a combination of intense physical exertion associated with the generation of significant amounts of reactive oxygen species (ROS), and possibly with having an unfavorable variant of the methylenetetrahydrofolate reductase (MTHFR), glutamate-cysteine ligase catalytic subunit (GCLC); glutamate-cysteine ligase modifier subunit (GCLM); glutathione S-transferase Pi 1 (GSTP1); glutathione synthetase (GSS) or cystathionine-β-synthase (CBS) genes may contribute to lower adaptation to exercise, but also to deterioration of health of people training endurance sports. * The main objective of the study is to verify the hypothesis that NAC supplementation has a beneficial effect on regeneration between intense exercise tests simulating a race characteristic for a given discipline. In addition, this study is aimed at checking whether genotype may modify the effectiveness of the supplementation measured as exercise and biochemical parameters . A double-blind study involving 100 women and men supplementing 1200 mg of N-acetylcysteine daily or 1200 mg of rice flour in three equal doses. Supplementation will last for 7 days. Blood sampling and body composition testing will be performed in the morning of the exercise test day. Discipline-specific exercise testing will be performed before and after the intervention.

Interventions

DIETARY_SUPPLEMENTN-acetylcysteine

100 women and men supplementing 1200 mg of N-acetylcysteine daily in three equal doses. Supplementation will last for 7 days.

DIETARY_SUPPLEMENTPlacebo

100 women and men supplementing 1200 mg of placebo daily in three equal doses. Supplementation will last for 7 days.

Sponsors

Poznan University of Life Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Masking description

Double (Participant/investigator)

Intervention model description

Eligible volunteers will be randomly assigned to one of the research groups. One of the groups will be taking the supplement for a period of 7 days, while the other group will be taking a placebo. Then a 3 week washout period will be performed. After that the groups will be exchanged and each participant will be assigned to a different group than it was in the first period of the study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Consent to participate in the study and acceptance of the established scheme for conducting the intervention * age range between 18 and 45 years old * regular training with a frequency of at least 3 times a week during the last year,

Exclusion criteria

* no consent to participate in the study and no acceptance of the established scheme of the conducted intervention * existing diseases of the blood system and neoplastic diseases * respiratory system diseases * obesity * any medical contraindications to exercise * Results obtained from exercise tests that do not meet the inclusion criteria * use of NAC during the last month * allergy to NAC * smoking * pregnancy and lactation

Design outcomes

Primary

MeasureTime frameDescription
Assesment of change in results of time trial testBaseline,1 week(min/test) change within groups and between groups

Secondary

MeasureTime frameDescription
Reduced glutathione (GSH)Baseline,1 weekGSH (µM) concentrations change within the group and between the groups
Oxidized glutathione (GSSG)Baseline,1 weekGSSG (µM) concentrations change within the group and between the groups
Homocysteine (Hcy)Baseline,1 weekHcy (µmol/l) concentrations change within the group and between the groups
Total cholesterol (TChol)Baseline,1 weekTChol (mg/dl) concentrations change within the group and between the groups
Blood HDL-cholesterol (HDL-C)Baseline,1 weekHDL-C (mg/dl) concentrations change within the group and between the groups
Blood LDL-cholesterol (LDL-C)1 weekLDL-C (mg/dl) concentrations change within the group and between the groups
Blood triacylglycerol (TAG)Baseline,1 weekTAG (mg/dl) concentrations change within the group and between the groups
Dietary intakeBaseline,1 weekmacro and micronutrient intake (g,mg,ug)
aspartate aminotransferase (ASPAT)1 weekASPAT \[U/l\] Changes within groups and between groups
Alanine transaminase (ALAT)Baseline,1 weekALAT \[U/l\] change within groups and between groups
Oxygen volume (VO2)Baseline,1 weekVO2 (ml/kg bw./min) change within groups and between groups
Carbon dioxide volume (VCO2)Baseline,1 weekVCO2 (ml/kgm.c./min) change within groups and between groups
Testosterone (T)Baseline,1 weekT (ng/dL) concentrations change within the group and between the groups
Cortisol (C)Baseline,1 weekC (ng/dL) concentrations change within the group and between the groups
Body mass(BM)Baseline, 1 weekChange in BM (kg) within groups and between groups
Fat Free Mass (FFM)Baseline, 1 weekFFM change within (kg) groups and between groups
Fat Mass% (FM%)Baseline, 1 weekFM% change within groups and between groups
Thiobarbituric Acid Reactive Species (TBARS)1 weekTBARS concentrations change within the group and between the groups

Countries

Poland

Contacts

PRINCIPAL_INVESTIGATORMarcin Sadowski, MSc

Poznań University of Life Science

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026