Redox Status and Immune Function

Skeletal Muscle Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930031
• Other study ID #: NACEXERCISE2016
• Status: Completed
• Phase: N/A
• First received: October 4, 2016
• Last updated: October 7, 2016
• Start date: January 2015
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Aseptic Inflammation
• Inflammation
• Skeletal Muscle Damage
• Skeletal Muscle Function

Intervention

Dietary Supplement:
• n-acetylcysteine
20 mg//kg/day, orally, daily for eight days following exercise
• Placebo
500 mL orally, daily for eight days following exercise

Locations

Country	Name	City	State
Greece	University of Athens, Medical School, Department of Clinical Therapeutics	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in protein carbonyls in red blood cells	Concentration of protein carbonyls	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in thiobarbituric acid reactive substances in red blood cells	Thiobarbituric acid reactive substances concentration in red blood cells	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in total antioxidant capacity in serum		Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in reduced glutathione in blood	Concentration of reduced glutathione in red blood cells	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in oxidized glutathione in blood	Concentration of oxidized glutathione in red blood cells	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in catalase activity in red blood cells		Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in creatine kinase activity in serum		Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in high sensitivity C-reactive protein in serum		Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise	No
Primary	Changes in white blood cell count in blood		Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in adhesion molecule concentration in blood	Measurement of soluble vascular cell adhesion molecule-1 (sVCAM-1) and soluble intercellular cell adhesion molecule-1 (sICAM-1) concentrations in plasma	Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise	No
Primary	Changes in cytokine concentration in serum	Measurement of interleukin-1ß (IL-1ß) and interleukin-6 (IL-6)	Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise, 8 days post-exercise	No
Primary	Changes in neutrophil count in blood	Cytofluorometric analysis of neutrophil count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in lymphocyte count in blood	Cytofluorometric analysis of lymphocyte count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in monocyte count in blood	Cytofluorometric analysis of monocyte count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in basophil count in blood	Cytofluorometric analysis of baseophil count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in eosinophil count in blood	Cytofluorometric analysis of eosinophil count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in T-helper cell count in blood	Cytofluorometric analysis of T-helper cell count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in T cytotoxic cell count in blood	Cytofluorometric analysis of T cytotoxic cell count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in natural killer-T (NK-T) cell count in blood	Cytofluorometric analysis of NK-T cell count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in 62L macrophage count in blood	Cytofluorometric analysis of 62L macrophage count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in B lympho cell count in blood	Cytofluorometric analysis of B lympho cell count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in natural killer (NK) cell count in blood	Cytofluorometric analysis of natural killer cell count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in macrophage count in blood	Cytofluorometric analysis of macrophage count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in HLA+/Macr+ macrophage count in blood	Cytofluorometric analysis of HLA+/Macr+ count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Primary	Changes in 11B+ macrophage count in blood	Cytofluorometric analysis of 11B+ macrophage count in blood	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Secondary	Changes in muscle performance	Assessment of maximal knee extensor eccentric peak torque on an isokinetic dynamometer at 60o/s.	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Secondary	Changes in delayed onset of muscle soreness	Assessment of the delayed onset of muscle soreness by palpation of the vastus lateralis and rectus femoris following a squat motion	Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise	No
Secondary	Maximal aerobic capacity	Assessment of maximal oxygen consumption	One day before exercise	No
Secondary	Body composition	Measurement of body composition by Dual Emission X-ray Absorptiometry (DXA)	One day before exercise	No
Secondary	Changes in dietary intake profile	Assessment of dietary intake with emphasis on antioxidant element intake	One day before exercise and daily for 8 consecutive days post-exercise	No