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

Not Applicable

Recruiting

• Conditions: Skeletal Muscle Performance; Gene Polymorphisms
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: N-acetylcysteine

• Registration Number: NCT05604586
• Lead Sponsor: Poznan University of Life Sciences

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.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-07-07
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-02
• Last Update Submitted: 2022-11-02
• Study First Posted: 2022-11-03
• Last Update Posted: 2022-11-03
• Primary Completion: 2025-03-15
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Supplement: Placebo Participants will undergo two exercise tests and daily supplementation with placebo orally in three doses a day for seven consecutive days.
N-acetylcysteine	N-acetylcysteine	Intervention: Dietary Supplement: N-acetylcysteine Participants will undergo two exercise tests and daily supplementation with N-acetylcysteine orally in three doses a day for seven consecutive days.

Primary Outcome Measures

Name	Time	Method
Assesment of change in results of time trial test	Baseline,1 week	(min/test) change within groups and between groups

Secondary Outcome Measures

Name	Time	Method
Oxidized glutathione (GSSG)	Baseline,1 week	GSSG (µM) concentrations change within the group and between the groups
Homocysteine (Hcy)	Baseline,1 week	Hcy (µmol/l) concentrations change within the group and between the groups
Blood HDL-cholesterol (HDL-C)	Baseline,1 week	HDL-C (mg/dl) concentrations change within the group and between the groups
Blood triacylglycerol (TAG)	Baseline,1 week	TAG (mg/dl) concentrations change within the group and between the groups
Dietary intake	Baseline,1 week	macro and micronutrient intake (g,mg,ug)
Carbon dioxide volume (VCO2)	Baseline,1 week	VCO2 (ml/kgm.c./min) change within groups and between groups
Cortisol (C)	Baseline,1 week	C (ng/dL) concentrations change within the group and between the groups
Fat Free Mass (FFM)	Baseline, 1 week	FFM change within (kg) groups and between groups
aspartate aminotransferase (ASPAT)	1 week	ASPAT \[U/l\] Changes within groups and between groups
Alanine transaminase (ALAT)	Baseline,1 week	ALAT \[U/l\] change within groups and between groups
Reduced glutathione (GSH)	Baseline,1 week	GSH (µM) concentrations change within the group and between the groups
Total cholesterol (TChol)	Baseline,1 week	TChol (mg/dl) concentrations change within the group and between the groups
Testosterone (T)	Baseline,1 week	T (ng/dL) concentrations change within the group and between the groups
Body mass(BM)	Baseline, 1 week	Change in BM (kg) within groups and between groups
Blood LDL-cholesterol (LDL-C)	1 week	LDL-C (mg/dl) concentrations change within the group and between the groups
Oxygen volume (VO2)	Baseline,1 week	VO2 (ml/kg bw./min) change within groups and between groups
Fat Mass% (FM%)	Baseline, 1 week	FM% change within groups and between groups
Thiobarbituric Acid Reactive Species (TBARS)	1 week	TBARS concentrations change within the group and between the groups

Trial Locations

Locations (1)

Poznan University of Life Science; 🇵🇱 Poznań, Poland