Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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17 October 2016 |
Main ID: |
NCT02930031 |
Date of registration:
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04/10/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Redox Status and Immune Function
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Scientific title:
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Evidence of a Redox-dependent Regulation of Immune Responses to Exercise-Induced Inflammation |
Date of first enrolment:
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January 2015 |
Target sample size:
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10 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02930031 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Asimina Mitrakou, Associate Prof. |
Address:
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Telephone:
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Email:
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Affiliation:
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Department of Diabetes and Metabolism Unit of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Aseptic Inflammation
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Skeletal Muscle Function
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Skeletal Muscle Damage
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Intervention(s)
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Dietary Supplement: n-acetylcysteine
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Dietary Supplement: Placebo
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Primary Outcome(s)
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Changes in 11B+ macrophage count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in reduced glutathione in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in B lympho cell count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in protein carbonyls in red blood cells
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in natural killer (NK) cell count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in T cytotoxic cell count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in lymphocyte count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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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]
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Changes in T-helper cell count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in 62L macrophage count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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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]
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Changes in catalase activity in red blood cells
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in basophil count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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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]
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Changes in eosinophil count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in HLA+/Macr+ macrophage count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in neutrophil count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in macrophage count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in total antioxidant capacity in serum
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in monocyte count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in white blood cell count in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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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]
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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]
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Changes in oxidized glutathione in blood
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in creatine kinase activity in serum
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Secondary Outcome(s)
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Body composition
[Time Frame: One day before exercise]
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Changes in muscle performance
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Changes in delayed onset of muscle soreness
[Time Frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise]
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Maximal aerobic capacity
[Time Frame: One day before exercise]
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Changes in dietary intake profile
[Time Frame: One day before exercise and daily for 8 consecutive days post-exercise]
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Secondary ID(s)
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NACEXERCISE2016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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