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 Folate Metabolism

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

Study Overview

• Status: Recruiting
• Conditions: Skeletal Muscle Performance; Gene Polymorphisms
• Intervention / Treatment: Dietary supplement: N-acetylcysteine; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agata Chmurzyńska, Professor; Phone Number: +48 61 8466181; Email: agata.chmurzynska@up.poznan.pl
• Study Contact Backup: Name: Marcin Sadowski, MSc; Phone Number: +48 61 8466179; Email: marcin.sadowski@up.poznan.pl

Study Locations

• Poland
  • Poznań, Poland
    • Recruiting
    • Poznan University of Life Science
    • Contact: Agata Chmurzynska, Professor; Phone Number: +48 61 8466179; Email: agata.chmurzynska@up.poznan.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: N-acetylcysteine; 100 women and men supplementing 1200 mg of N-acetylcysteine daily in three equal doses. Supplementation will last for 7 days.
Placebo Comparator: Placebo; Supplement: Placebo Participants will undergo two exercise tests and daily supplementation with placebo orally in three doses a day for seven consecutive days.	Dietary supplement: Placebo; 100 women and men supplementing 1200 mg of placebo daily in three equal doses. Supplementation will last for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assesment of change in results of time trial test	(min/test) change within groups and between groups	Baseline,1 week

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Poznan University of Life Sciences
• Investigators: Principal Investigator: Marcin Sadowski, MSc, Poznan University of Life Science

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): March 15, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: N-acetylcysteine; gene polymorphism; Sport performance
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: NAC/29112021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No