World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2016
Main ID:  NCT02930031
Date of registration: 04/10/2016
Prospective Registration: No
Primary sponsor: National and Kapodistrian University of Athens
Public title: Redox Status and Immune Function
Scientific title: Evidence of a Redox-dependent Regulation of Immune Responses to Exercise-Induced Inflammation
Date of first enrolment: January 2015
Target sample size: 10
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02930031
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science  
Phase:  N/A
Countries of recruitment
Greece
Contacts
Name:     Asimina Mitrakou, Associate Prof.
Address: 
Telephone:
Email:
Affiliation:  Department of Diabetes and Metabolism Unit of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 30 Years
Gender: Male
Health Condition(s) or Problem(s) studied
Aseptic Inflammation
Skeletal Muscle Function
Skeletal Muscle Damage
Intervention(s)
Dietary Supplement: n-acetylcysteine
Dietary Supplement: Placebo
Primary Outcome(s)
Changes in 11B+ macrophage count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in reduced glutathione in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in B lympho cell count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in protein carbonyls in red blood cells [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in natural killer (NK) cell count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in T cytotoxic cell count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in lymphocyte count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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]
Changes in T-helper cell count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in 62L macrophage count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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]
Changes in catalase activity in red blood cells [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in basophil count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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]
Changes in eosinophil count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in HLA+/Macr+ macrophage count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in neutrophil count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in macrophage count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in total antioxidant capacity in serum [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in monocyte count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in white blood cell count in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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]
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]
Changes in oxidized glutathione in blood [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in creatine kinase activity in serum [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Secondary Outcome(s)
Body composition [Time Frame: One day before exercise]
Changes in muscle performance [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Changes in delayed onset of muscle soreness [Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
Maximal aerobic capacity [Time Frame: One day before exercise]
Changes in dietary intake profile [Time Frame: One day before exercise and daily for 8 consecutive days post-exercise]
Secondary ID(s)
NACEXERCISE2016
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history