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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise

NCT02937376

G6PD Deficiency

UNKNOWN EARLY_PHASE1

NAC Supplementation and Soccer Specific Performance

NCT04523675

Skeletal Muscle Damage Exercise-induced Aseptic Inflammation Skeletal Muscle Performance +1 more

COMPLETED NA

NAC Supplementation and Skeletal Muscle Performance

NCT01778309

Skeletal Muscle Damage Skeletal Muscle Performance Intgracellular Signaling in Skeletal Muscle +1 more

COMPLETED NA

Pharmacokinetic Profile of N-Acetyl Cysteine

NCT06252519

Pharmacokinetics

COMPLETED NA

Redox Status and Immune Function

NCT02930031

Skeletal Muscle Damage Aseptic Inflammation Skeletal Muscle Function

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Skeletal Muscle Performance Gene Polymorphisms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Double (Participant/investigator)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Supplement: Placebo Participants will undergo two exercise tests and daily supplementation with placebo orally in three doses a day for seven consecutive days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N-acetylcysteine

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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,

* use of NAC during the last month
* allergy to NAC
* smoking
* pregnancy and lactation

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes