NAC Supplementation and Soccer Specific Performance

August 20, 2020 updated by: Ioannis G. Fatouros, University of Thessaly

Effects of NAC Supplementation on Immune Function, Inflammatory and Performance Responses of Elite Soccer Players Participated in Three Repetitive Games.

In this investigation the investigators utilized NAC supplementation to boost GSH availability during an one-week-microcycle consisting of three soccer games, in order to test the hypotheses that: i) antioxidant supplementation may enhance the recovery of performance and physiological stress variables following multiple match-plays and ii) redox status perturbations are critical in regulating the inflammatory response and repair in skeletal muscle, following repetitive exercise-induced muscle injuries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After exercise-induced muscle microtrauma the thiol/disulfide couple of reduced (GSH) and oxidized glutathione (GSSG) is a key regulator of important transcriptional pathways that control the inflammatory response and recovery of skeletal muscle.

The objective was to examine how thiol-based antioxidant supplementation affects the muscle damage, oxidative stress, inflammatory and immune responses, as well as the level of post-game fatigue and muscle's recovery kinetics in response to three soccer games within a week. Participants were randomly assigned to one of four groups: i) Experimental-NAC [EXP-NAC, N=10, participated in daily training sessions and three games and received NAC (20 mg/kg/day)], ii) Experimental-Placebo (EXP-Pla, N=10, participated in daily training sessions and three games and received Placebo), iii) Control-NAC [CON-NAC, N=10, participated in daily training sessions only and received NAC(20 mg/kg/day)] and iv) Control-Placebo (CON-Pla, N=10, participated in daily training sessions only and received Placebo). Blood samples were collected at baseline, post-games and daily during recovery. Performance was assessed at baseline and daily during recovery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Tríkala, Greece, 42100
        • Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Participation at elite level (top three division leagues) of soccer competition for at least five years
  • Abstained from consumption of performance-enhancing supplements, antioxidant supplements and medications (for at least 6 months before and during the study)
  • Participation in at least six two-hour training sessions and one match per week
  • Non-smokers

Exclusion Criteria:

  • A known NAC intolerance or allergy
  • A recent febrile illness
  • History of muscle lesion
  • Lower limb trauma
  • Metabolic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EXP-NAC
Participated in daily training sessions and three games, and supplemented daily with N-acetylcysteine, orally in three daily dosages (morning-midday-evening),for seven consecutive days.
Dietary supplement: N-acetylcysteine
Orally in three daily dosages (morning-midday-evening), at 20 mg/kg/day, for seven consecutive days.
Other Names:
  • NAC
Experimental: EXP-Pla
Participated in daily training sessions and three games, and supplemented daily with Placebo, orally in three daily dosages (morning-midday-evening), for seven consecutive days.
Dietary supplement: Placebo
500 mL drink that contained water (375 mL), sugar-free cordial (125 ml), and 2 g of low-calorie glucose/dextrose powder. Orally in three daily dosages (morning-midday-evening), for seven consecutive days.
Active Comparator: CON-NAC
Participated in daily training sessions only and supplemented daily with N-acetylcysteine, orally in three daily dosages (morning-midday-evening),for seven consecutive days.
Dietary supplement: N-acetylcysteine
Orally in three daily dosages (morning-midday-evening), at 20 mg/kg/day, for seven consecutive days.
Other Names:
  • NAC
Active Comparator: CON-Pla
Participated in daily training sessions only and supplemented daily with Placebo, orally in three daily dosages (morning-midday-evening), for seven consecutive days.
Dietary supplement: Placebo
500 mL drink that contained water (375 mL), sugar-free cordial (125 ml), and 2 g of low-calorie glucose/dextrose powder. Orally in three daily dosages (morning-midday-evening), for seven consecutive days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in total antioxidant capacity in serum
Time Frame: At baseline and daily throughout the study, up to 11 days
At baseline and daily throughout the study, up to 11 days
Change in protein carbonyls in serum
Time Frame: At baseline and daily throughout the study, up to 11 days
At baseline and daily throughout the study, up to 11 days
Change in thiobarbituric acid reactive substances in serum
Time Frame: At baseline and daily throughout the study, up to 11 days
At baseline and daily throughout the study, up to 11 days
Change in reduced glutathione in red blood cells
Time Frame: At baseline and daily throughout the study, up to 11 days
At baseline and daily throughout the study, up to 11 days
Change in oxidized glutathione in red blood cells
Time Frame: At baseline and daily throughout the study, up to 11 days
At baseline and daily throughout the study, up to 11 days
Change in creatine kinase in activity in plasma
Time Frame: At baseline and daily throughout the study, up to 11 days
At baseline and daily throughout the study, up to 11 days
Change in white blood cell count in blood
Time Frame: At baseline and daily throughout the study, up to 11 days
At baseline and daily throughout the study, up to 11 days
Change in repeated sprint ability
Time Frame: At baseline and daily throughout the study, up to 11 days
Players' repeated sprint ability was assessed via a repeared sprint test. Each player performed 5 x 30 meters sprints interspersed by 25 seconds of active recovery. Sprint time was recorded by using infrared photoelectrical gates.
At baseline and daily throughout the study, up to 11 days
Change in high intensity running during the game
Time Frame: During games 1, 2 and 3
High intensity running (i.e. > 14km/h) during the games was monitored by utilizing high time-resolution GPS devices.
During games 1, 2 and 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in blood lactate concentration during the game
Time Frame: During games 1, 2 and 3
During games 1, 2 and 3
Change in average heart rate during the game
Time Frame: During games 1, 2 and 3
During games 1, 2 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Thessaly

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: IOANNIS G FATOUROS, Ph.D., UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NAC-SOCCER-2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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