Clinical trial NCT05604586: Assessment of the Impact of N-acetylcysteine Supplementation on Physical Performance
Official title: Assessment of the Impact of N-acetylcysteine Supplementation on Physical Performance Depending on the Polymorphism of Genes Related to Folate Metabolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skeletal Muscle Performance
Gene Polymorphisms
Keywords: Sport performance
gene polymorphism
N-acetylcysteine
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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 maltodextrin 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.

Eligibility criteria: 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 4 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

Primary outcomes:
measure: Assesment of change in results of time trial test
timeFrame: Baseline,1 week
Secondary outcomes:
measure: Reduced glutathione (GSH)
timeFrame: Baseline,1 week
measure: Oxidized glutathione (GSSG)
timeFrame: Baseline,1 week
measure: Homocysteine (Hcy)
timeFrame: Baseline,1 week
measure: Total cholesterol (TChol)
timeFrame: Baseline,1 week
measure: Blood HDL-cholesterol (HDL-C)
timeFrame: Baseline,1 week
measure: Blood LDL-cholesterol (LDL-C)
timeFrame: 1 week
measure: Blood triacylglycerol (TAG)
timeFrame: Baseline,1 week
measure: Dietary intake
timeFrame: Baseline,1 week
measure: aspartate aminotransferase (ASPAT)
timeFrame: 1 week
measure: Alanine transaminase (ALAT)
timeFrame: Baseline,1 week
measure: Oxygen volume (VO2)
timeFrame: Baseline,1 week
measure: Carbon dioxide volume (VCO2)
timeFrame: Baseline,1 week
measure: Testosterone (T)
timeFrame: Baseline,1 week
measure: Cortisol (C)
timeFrame: Baseline,1 week
measure: Body mass(BM)
timeFrame: Baseline, 1 week
measure: Fat Free Mass (FFM)
timeFrame: Baseline, 1 week
measure: Fat Mass% (FM%)
timeFrame: Baseline, 1 week
measure: Thiobarbituric Acid Reactive Species (TBARS)
timeFrame: 1 week
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Life Science
Study officials:
affiliation: Poznań University of Life Science
name: Marcin Sadowski, MSc
role: PRINCIPAL_INVESTIGATOR
References: