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NCT Number: NCT02930031

Redox Status and Immune Function

In this investigation the investigators utilized N-acetylcysteine (NAC) supplementation to enhance reduced glutathione (GSH) stores during an 8-day recovery period from a strenuous eccentric exercise protocol in order to test the hypotheses: i) redox status perturbations in skeletal muscle are pivotal for the immune responses and ii) antioxidant supplementation may alter immune cell responses following exercise-induced muscle microtrauma.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Athens, Medical School, Department of Clinical Therapeutics

Athens, 11527, Greece

About this study

The major thiol-disulfide couple of GSH and oxidized glutathione (GSSG) is a crucial regulator of the main transcriptional pathways regulating aseptic inflammation and recovery of skeletal muscle following aseptic injury. Antioxidant supplementation may hamper exercise-induced inflammatory responses.

The objective was to examine how thiol-based antioxidant supplementation affects immune mobilization following exercise-induced skeletal muscle microtrauma. In a two-trial, double-blind, crossover, repeated measures design, 10 young men received either placebo or NAC (20 mg/kg/day) immediately after a muscle-damaging exercise protocol (300 eccentric contractions) and for eight consecutive days. Blood sampling and performance assessment were performed pre-exercise, 2h post-exercise and daily for 8 consecutive days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recreationally trained (VO2max > 45 ml/kg/min)
  • Engaged in regular exercise for ≥3 times/week for > 12 months
  • non-smokers
  • Abstain from exercise during the course of the two trials
  • No consumption of performance-enhancing substances, antioxidants, caffeine, alcohol and/or medications during the study.

Exclusion criteria

  • NAC intolerance
  • Recent musculoskeletal injuries of the lower limbs
  • Febrile illness
  • History of muscle lesion.

Treatment and study plan

N-acetylcysteine

Dietary Supplement

20 mg//kg/day, orally, daily for eight days following exercise

Other names: NAC

Placebo

Dietary Supplement

500 mL orally, daily for eight days following exercise

Primary outcomes

  1. Changes in protein carbonyls in red blood cells

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Concentration of protein carbonyls

  2. Changes in thiobarbituric acid reactive substances in red blood cells

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Thiobarbituric acid reactive substances concentration in red blood cells

  3. Changes in total antioxidant capacity in serum

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

  4. Changes in reduced glutathione in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Concentration of reduced glutathione in red blood cells

  5. Changes in oxidized glutathione in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Concentration of oxidized glutathione in red blood cells

  6. Changes in catalase activity in red blood cells

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

  7. Changes in creatine kinase activity in serum

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

  8. Changes in high sensitivity C-reactive protein in serum

    Time frame: Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise

  9. Changes in white blood cell count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

  10. Changes in adhesion molecule concentration in blood

    Time frame: Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise

    Measurement of soluble vascular cell adhesion molecule-1 (sVCAM-1) and soluble intercellular cell adhesion molecule-1 (sICAM-1) concentrations in plasma

  11. Changes in cytokine concentration in serum

    Time frame: Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise, 8 days post-exercise

    Measurement of interleukin-1β (IL-1β) and interleukin-6 (IL-6)

  12. Changes in neutrophil count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of neutrophil count in blood

  13. Changes in lymphocyte count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of lymphocyte count in blood

  14. Changes in monocyte count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of monocyte count in blood

  15. Changes in basophil count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of baseophil count in blood

  16. Changes in eosinophil count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of eosinophil count in blood

  17. Changes in T-helper cell count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of T-helper cell count in blood

  18. Changes in T cytotoxic cell count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of T cytotoxic cell count in blood

  19. Changes in natural killer-T (NK-T) cell count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of NK-T cell count in blood

  20. Changes in 62L macrophage count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of 62L macrophage count in blood

  21. Changes in B lympho cell count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of B lympho cell count in blood

  22. Changes in natural killer (NK) cell count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of natural killer cell count in blood

  23. Changes in macrophage count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of macrophage count in blood

  24. Changes in HLA+/Macr+ macrophage count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of HLA+/Macr+ count in blood

  25. Changes in 11B+ macrophage count in blood

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Cytofluorometric analysis of 11B+ macrophage count in blood

Secondary outcomes

  1. Changes in muscle performance

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Assessment of maximal knee extensor eccentric peak torque on an isokinetic dynamometer at 60o/s.

  2. Changes in delayed onset of muscle soreness

    Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

    Assessment of the delayed onset of muscle soreness by palpation of the vastus lateralis and rectus femoris following a squat motion

  3. Maximal aerobic capacity

    Time frame: One day before exercise

    Assessment of maximal oxygen consumption

  4. Body composition

    Time frame: One day before exercise

    Measurement of body composition by Dual Emission X-ray Absorptiometry (DXA)

  5. Changes in dietary intake profile

    Time frame: One day before exercise and daily for 8 consecutive days post-exercise

    Assessment of dietary intake with emphasis on antioxidant element intake

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

Evidence of a Redox-dependent Regulation of Immune Responses to Exercise-Induced Inflammation

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 11, 2016
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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