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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04523675
Other study ID # NAC-SOCCER-2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date December 2016

Study information

Verified date August 2020
Source University of Thessaly
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 28 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Greece Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly Tríkala

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in total antioxidant capacity in serum At baseline and daily throughout the study, up to 11 days
Primary Change in protein carbonyls in serum At baseline and daily throughout the study, up to 11 days
Primary Change in thiobarbituric acid reactive substances in serum At baseline and daily throughout the study, up to 11 days
Primary Change in reduced glutathione in red blood cells At baseline and daily throughout the study, up to 11 days
Primary Change in oxidized glutathione in red blood cells At baseline and daily throughout the study, up to 11 days
Primary Change in creatine kinase in activity in plasma At baseline and daily throughout the study, up to 11 days
Primary Change in white blood cell count in blood At baseline and daily throughout the study, up to 11 days
Primary 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
Primary 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 Change in blood lactate concentration during the game During games 1, 2 and 3
Secondary Change in average heart rate during the game During games 1, 2 and 3
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