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CompletedNCT04523675Updated Aug 21, 2020

NAC Supplementation and Soccer Specific Performance

An interventional study of N-acetylcysteine and Placebo in Skeletal Muscle Damage, Exercise-induced Aseptic Inflammation and Skeletal Muscle Performance, sponsored by University of Thessaly. Completed at 1 site in Greece. Open to male participants aged 18 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-21.

Sponsored by University of Thessaly · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 4 years 2 months after the study started (first participant enrolled Apr 2016, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 28 Years
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Skeletal Muscle Damage
  • Exercise-induced Aseptic Inflammation
  • Skeletal Muscle Performance
  • Antioxidant Status

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03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.

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Lead sponsor

University of Thessaly is the lead sponsor of 188 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 28 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • A known NAC intolerance or allergy
  • A recent febrile illness
  • History of muscle lesion
  • Lower limb trauma
  • Metabolic diseases
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • Dietary supplementN-acetylcysteine

    Orally in three daily dosages (morning-midday-evening), at 20 mg/kg/day, for seven consecutive days.

    Also known as: NAC

  • Dietary supplementPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. Change in total antioxidant capacity in serum

    Time frame: At baseline and daily throughout the study, up to 11 days

  2. Change in protein carbonyls in serum

    Time frame: At baseline and daily throughout the study, up to 11 days

  3. Change in thiobarbituric acid reactive substances in serum

    Time frame: At baseline and daily throughout the study, up to 11 days

  4. Change in reduced glutathione in red blood cells

    Time frame: At baseline and daily throughout the study, up to 11 days

  5. Change in oxidized glutathione in red blood cells

    Time frame: At baseline and daily throughout the study, up to 11 days

  6. Change in creatine kinase in activity in plasma

    Time frame: At baseline and daily throughout the study, up to 11 days

  7. Change in white blood cell count in blood

    Time frame: At baseline and daily throughout the study, up to 11 days

  8. Change in repeated sprint ability

    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.

    Time frame: At baseline and daily throughout the study, up to 11 days

  9. Change in high intensity running during the game

    High intensity running (i.e. \> 14km/h) during the games was monitored by utilizing high time-resolution GPS devices.

    Time frame: During games 1, 2 and 3

Secondary outcomes

  1. Change in blood lactate concentration during the game

    Time frame: During games 1, 2 and 3

  2. Change in average heart rate during the game

    Time frame: During games 1, 2 and 3

07

Study locations

1 site
  • Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
    Tríkala, 42100, Greece
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04523675
Lead sponsor
University of Thessaly
Responsible party
Ioannis G. Fatouros (Associate Professor, University of Thessaly) — Principal investigator
First posted
Aug 21, 2020
Start date
Apr 2016
Primary completion
Jul 2016
Completion
Dec 2016
Last update
Aug 21, 2020

Study contacts

IOANNIS G FATOUROS, Ph.D.
principal investigator · UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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