NCT01778309

Brief Summary

In this investigation the investigators utilized NAC administration to foster GSH availability during an 8-day period following eccentric exercise-induced muscle damage in order to test our hypotheses: i) antioxidant supplementation does not disturb performance and adaptations induced by exercise-induced muscle injury and ii) redox status perturbations in skeletal muscle are pivotal for the regulation of muscle' inflammatory response and repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

1.7 years

First QC Date

January 21, 2013

Last Update Submit

January 25, 2013

Conditions

Keywords

aseptic inflammationskeletal muscle functionexercise

Outcome Measures

Primary Outcomes (24)

  • Change in reduced glutathione in blood

    Concentration of reduced glutathione in red blood cells

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in reduced glutathione in muscle

    concentration of reduced glutathione in quadriceps skeletal muscle group

    one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise

  • Change in protein carbonyls in red blood cells and serum

    concentration of protein carbonyls

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in protein carbonyls in muscle

    protein carbonyl concentration in vastus lateralis skeletal muscle

    one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise

  • Change in thiobarbituric acid reactive substances in red blood cells and serum

    thiobarbituric acid reactive substances concentration in serum and red blood cells

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in thiobarbituric acid reactive substances in muscle

    thiobarbituric acid reactive substances concentration in vastus lateralis skeletal muscle

    one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise

  • Change in oxidized glutathione in red blood cells and blood

    Concentration of oxidized glutathione in red blood cells and whole blood

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in total antioxidant capacity in serum

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in oxidized glutathione in muscle

    concentration of oxidized glutathione in vastus lateralis skeletal muscle

    one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise

  • Change in catalase activity in red blood cells and serum

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in glutathione peroxidase activity in red blood cells

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in creatine kinase activity in plasma

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in C-reactive protein in plasma

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in macrophage infiltration in muscle

    one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise

  • Change in white blood cell count in blood

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in neutrophil count in blood

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in fatty acid binding protein in plasma

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in cortisol concentration in blood

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in testosterone concentration in plasma

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in cytokine concentration in plasma

    Measurement of IL-1β, IL-4, IL-6, TNF-α, IL-8, IL-10, IL-12p70 concentrations in plasma

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in adhesion molecule concentration in blood

    Measurement of ICAM-1, VCAM-1, sP-selectin, sE-selectin concentrations in plasma

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Change in intracellular signalling proteins in muscle

    Measurement of phosphorylation levels of protein kinase B (Akt), mammalian target of rapamycin (mTOR), serine/threonine kinase (p70S6K), ribosomal protein S6 (rpS6), nuclear factor κB (NFκB), serine⁄threonine mitogen activated protein kinase (p38-MAPK) in vastus lateralis muscle.

    one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise

  • Change in myogenic determination factor (MyoD) protein levels in muscle

    MyoD expression in vastus lateralis muscle

    one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise

  • Change in tumor necrosis factor α in muscle

    Protein levels of TNF-α in vastus lateralis muscle

    one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise

Secondary Outcomes (5)

  • Change in muscle function of knee extensor and flexor muscle

    one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise

  • Body composition

    One day before exercise

  • Maximal aerobic capacity

    One day before exercise

  • Change in profile of dietary intake

    one hour before exercise, daily for 8 days post-exercise

  • Change in side effect occurence

    one hour before exercise, daily for 8 days post-exercise

Study Arms (1)

n-acetylcysteine/placebo supplementation

EXPERIMENTAL

n-acetylcysteine supplementation, orally in three daily dosages, at 20 mg/kg/day, daily for eight days after exercise placebo, orally in three daily dosages, content: 500 mL drink that contained water (375 mL), sugar-free cordial (125 ml), and 2 g of low-calorie glucose/dextrose powder.

Dietary Supplement: n-acetylcysteine supplementation

Interventions

n-acetylcysteine administration: 20 mg//kg/day, orally, daily for eight days following exercise placebo administration: 500 mL orally, daily for eight days following exercise

Also known as: Exercise-induced skeletal muscle damage
n-acetylcysteine/placebo supplementation

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • a) recreationally trained as evidenced by their maximal oxygen consumption levels (VO2max \>45 ml/kg/min), b) were engaged in systematic exercise at least three times/week for ≥12 months), c) non-smokers, d) abstained from any vigorous physical activity during the study, e)abstained from consumption of caffeine, alcohol, performance-enhancing or antioxidant supplements, and medications during the study.

You may not qualify if:

  • a) a known NAC intolerance or allergy, b) a recent febrile illness, c) history of muscle lesion, d) lower limb trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Physical Education & Sport Performance

Komotini, Thrace, 69100, Greece

Location

Related Publications (1)

  • Michailidis Y, Karagounis LG, Terzis G, Jamurtas AZ, Spengos K, Tsoukas D, Chatzinikolaou A, Mandalidis D, Stefanetti RJ, Papassotiriou I, Athanasopoulos S, Hawley JA, Russell AP, Fatouros IG. Thiol-based antioxidant supplementation alters human skeletal muscle signaling and attenuates its inflammatory response and recovery after intense eccentric exercise. Am J Clin Nutr. 2013 Jul;98(1):233-45. doi: 10.3945/ajcn.112.049163. Epub 2013 May 29.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ioannis F Fatouros, Ph.D.

    Democritus University of Thrace, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 21, 2013

First Posted

January 29, 2013

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

April 1, 2012

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations