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

NCT05604586 | Unknown

• 1 other identifier: NAC/29112021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Skeletal Muscle Performance; Gene Polymorphisms

Keywords

Sport performance; gene polymorphism; N-acetylcysteine

Outcome Measures

Primary Outcomes (1)

• Assesment of change in results of time trial test

  (min/test) change within groups and between groups

  Baseline,1 week

Secondary Outcomes (18)

• Reduced glutathione (GSH)

  Baseline,1 week

• Oxidized glutathione (GSSG)

  Baseline,1 week

• Homocysteine (Hcy)

  Baseline,1 week

• Total cholesterol (TChol)

  Baseline,1 week

• Blood HDL-cholesterol (HDL-C)

  Baseline,1 week

Study Arms (2)

N-acetylcysteine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

N-acetylcysteine DIETARY_SUPPLEMENT

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

N-acetylcysteine

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

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

Sponsors & Collaborators

• Poznan University of Life Sciences: lead

Study Sites (1)

Poznan University of Life Science

Poznan, Poland

RECRUITING

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Marcin Sadowski, MSc

  Poznań University of Life Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agata Chmurzyńska, Professor

CONTACT

61 8466181; agata.chmurzynska@up.poznan.pl

Marcin Sadowski, MSc

CONTACT

61 8466179; marcin.sadowski@up.poznan.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant/investigator)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: November 3, 2022
• Study Start: May 1, 2022
• Primary Completion: March 15, 2025
• Study Completion: December 31, 2025
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)