Clinical trial NCT02930031: Redox Status and Immune Function
Official title: Evidence of a Redox-dependent Regulation of Immune Responses to Exercise-Induced Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skeletal Muscle Damage
Aseptic Inflammation
Skeletal Muscle Function
Keywords: muscle injury
exercise
redox status
immune cells
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in protein carbonyls in red blood cells
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in thiobarbituric acid reactive substances in red blood cells
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in total antioxidant capacity in serum
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in reduced glutathione in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in oxidized glutathione in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in catalase activity in red blood cells
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in creatine kinase activity in serum
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in high sensitivity C-reactive protein in serum
timeFrame: Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise
measure: Changes in white blood cell count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in adhesion molecule concentration in blood
timeFrame: Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise
measure: Changes in cytokine concentration in serum
timeFrame: Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise, 8 days post-exercise
measure: Changes in neutrophil count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in lymphocyte count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in monocyte count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in basophil count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in eosinophil count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in T-helper cell count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in T cytotoxic cell count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in natural killer-T (NK-T) cell count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in 62L macrophage count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in B lympho cell count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in natural killer (NK) cell count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in macrophage count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in HLA+/Macr+ macrophage count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in 11B+ macrophage count in blood
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Secondary outcomes:
measure: Changes in muscle performance
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Changes in delayed onset of muscle soreness
timeFrame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
measure: Maximal aerobic capacity
timeFrame: One day before exercise
measure: Body composition
timeFrame: One day before exercise
measure: Changes in dietary intake profile
timeFrame: One day before exercise and daily for 8 consecutive days post-exercise
Other outcomes:
Locations:
city: Athens
country: Greece
facility: University of Athens, Medical School, Department of Clinical Therapeutics
Study officials:
affiliation: Department of Diabetes and Metabolism Unit of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens
name: Asimina Mitrakou, Associate Prof.
role: STUDY_DIRECTOR
References: