NCT04523675

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

June 22, 2020

Last Update Submit

August 20, 2020

Conditions

Outcome Measures

Primary Outcomes (9)

  • Change in total antioxidant capacity in serum

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

  • Change in protein carbonyls in serum

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

  • Change in thiobarbituric acid reactive substances in serum

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

  • Change in reduced glutathione in red blood cells

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

  • Change in oxidized glutathione in red blood cells

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

  • Change in creatine kinase in activity in plasma

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

  • Change in white blood cell count in blood

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

  • 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.

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

  • 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.

    During games 1, 2 and 3

Secondary Outcomes (2)

  • Change in blood lactate concentration during the game

    During games 1, 2 and 3

  • Change in average heart rate during the game

    During games 1, 2 and 3

Study Arms (4)

EXP-NAC

EXPERIMENTAL

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

EXP-Pla

EXPERIMENTAL

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

CON-NAC

ACTIVE COMPARATOR

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

CON-Pla

ACTIVE COMPARATOR

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

N-acetylcysteineDIETARY_SUPPLEMENT

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

Also known as: NAC
CON-NACEXP-NAC
PlaceboDIETARY_SUPPLEMENT

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.

CON-PlaEXP-Pla

Eligibility Criteria

Age18 Years - 28 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly

Trikala, 42100, Greece

Location

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • IOANNIS G FATOUROS, Ph.D.

    UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 22, 2020

First Posted

August 21, 2020

Study Start

April 1, 2016

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

August 21, 2020

Record last verified: 2020-08

Locations