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

Poznan University of Life Sciences

Status: Enrolling

Conditions: Skeletal Muscle Performance; Gene Polymorphisms

Treatments: Dietary Supplement: Placebo; Dietary Supplement: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT05604586

NAC/29112021

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

N-acetylcysteine

Experimental group

Description:

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.

Treatment:

Dietary Supplement: N-acetylcysteine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo