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

Skeletal Muscle Performance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05604586
• Other study ID #: NAC/29112021
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2022
• Source: Poznan University of Life Sciences
• Contact: Agata Chmurzynska, Professor
• Phone: 61 8466181
• Email: agata.chmurzynska[@]up.poznan.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Skeletal Muscle Performance

Intervention

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

Locations

Country	Name	City	State
Poland	Poznan University of Life Science	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Life Sciences

Country where clinical trial is conducted

Poland, 

Outcome

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