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The Effects of N-acetylcysteine on Performance and Redox Homeostasis

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ClinicalTrials.gov Identifier: NCT03121222
Recruitment Status : Completed
First Posted : April 20, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborators:
National and Kapodistrian University of Athens
European University Cyprus
Information provided by (Responsible Party):
Vassilis Paschalis, National and Kapodistrian University of Athens

Brief Summary:
The main objective of the present study was to investigate whether N-acetylcysteine supplementation in individuals with low glutathione levels would confer ergogenic effects by replenishing glutathione levels and by reducing oxidative stress. Towards this aim, investigators sought to exploit the large inter-individual variability in redox biomarker levels. More specifically, investigators screened 100 male participants for glutathione baseline levels in blood and formed three stratified groups according to this value (i.e., low, moderate and high; 12 individuals per group). After by-passing the regression to the mean artefact by performing a second glutathione measurement in the three aforementioned groups, investigators assessed both aerobic and anaerobic physical performance in order to acquire a more comprehensive view about the ergogenic effectiveness of the antioxidant treatment. This was accomplished by implementing three different whole-body physical performance tests (i.e., VO2max test, time trial and Wingate), as opposed to most in vivo studies that either applied isolated body-part exercise tests (e.g., by isokinetic dynamometry) or performed a single exercise test (e.g., time-to-fatigue test). It was hypothesised, that data of the present investigation will bridge the chasm between the scientific (i.e., chronic antioxidant supplementation blunts exercise performance and adaptations) and the community-based (i.e., free radicals should anyway be counteracted by "protective" exogenous antioxidants) truths about the role of antioxidants as ergogenic aids. It was also hypothesised that the results will show that low glutathione levels are linked to decreased aerobic and anaerobic physical performance accompanied by increased levels of oxidative stress and that N-acetylcysteine supplementation will restore both performance and redox homeostasis. Based on the findings of the present investigation, the widespread routine practice of consuming antioxidants during exercise training could be changed and the consumption of antioxidants would be restricted only for those who are deficient in glutathione.

Condition or disease Intervention/treatment Phase
Glutathione Metabolism Anemias Drug: N-acetylcysteine Drug: Lactose Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Double blind crossover design
Primary Purpose: Screening
Official Title: N-acetylcysteine Supplementation in Individuals With Low Glutathione Levels: the Effects on Physical Performance and Redox Homeostasis
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : February 15, 2016
Actual Study Completion Date : September 12, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Lactose
The placebo group received orally two lactose tablets per day for 30 days. Each individual received the capsules pre-packed in daily doses labeled with the day of consumption.
Drug: Lactose
The placebo group received orally two lactose tablets per day. The participants were instructed to receive the capsules every twelve hours. Each individual received the capsules pre-packed in daily doses labeled with the day of consumption. The supplementation period was 30-day for placebo.

Experimental: N-acetylcysteine
The antioxidant group received orally two N-acetylcysteine tablets (each tablet contained 600 mg of NAC; Lamberts Health Care Ltd, Kent, United Kingdom). The participants were instructed to receive the capsules every twelve hours in order to achieve high concentration of N-acetylcysteine throughout the 24 h. Each individual received the capsules pre-packed in daily doses labeled with the day of consumption.
Drug: N-acetylcysteine
The antioxidant group received orally two N-acetylcysteine tablets (each tablet contained 600 mg of NAC; Lamberts Health Care Ltd, Kent, United Kingdom). The participants were instructed to receive the capsules every twelve hours in order to achieve high concentration of N-acetylcysteine throughout the 24 h. Each individual received the capsules pre-packed in daily doses labeled with the day of consumption. The supplementation period was 30-day for N-acetylcysteine.




Primary Outcome Measures :
  1. Measurement of maximal oxygen consumption (ml/kg/min) [ Time Frame: 64 days ]

    Maximal oxygen consumption was assessed (using incremental cycling test to volitional exhaustion) on cycle ergometers (Monark, Vansbro, Sweden). Briefly, after a 5-min warm-up period at 100W, workload increased by 50W every 2.5 minutes until heart rate reached 160 bpm. Then, workload increased by 25W every 2.5 minutes until exhaustion. Respiratory gas variables were measured using a metabolic cart (Quark b2, Cosmed, Italy), which was calibrated before each test using standard gases of known concentration.

    Maximal oxygen consumption along with time trial and wingate test were used for assessing both aerobic and anaerobic physical performance in order to acquire a more comprehensive view about the ergogenic effectiveness of the antioxidant treatment.



Secondary Outcome Measures :
  1. Measurement of glutathione levels (μmol/g Hb) [ Time Frame: 64 days ]

    Erythrocyte GSH was determined spectrophotometrically. 20 μL of erythrocyte lysate treated with 5% TCA mixed with 660 μL of67 mMsodium potassium phosphate (pH 8.0) and 330 μL of 1mM 5,5- dithiobis-2 nitrobenzoate. The samples were incubated in the dark at room temperature for 45 min, and the absorbance was read at 412 nm.

    The measurement of glutathione was used for assessing the efficacy of NAC supplementation to restore glutathione levels in the low-glutathione group as well as the effects of NAC supplementation in the medium and high glutathione groups.




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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study was limited to males in order to avoid any interference with the hormonal fluctuations during the menstrual cycle.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects who participated recreationally in physical activities less than 3 times per week.

Exclusion Criteria:

  • Subjects were excluded from the study, if they reported any musculoskeletal injury that would limit their ability to perform the exercise sessions. Participants were asked to recall whether they had participated in regular resistance or aerobic training or in unaccustomed exercise during the period before the study entry. Individuals who reported such activities were precluded from the study. Smoking and consumption of antioxidant supplements the days prior to the study were additional exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121222


Locations
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Cyprus
European University Cyprus
Nicosia, Cyprus, 1516
Greece
National and Kapodistrian University of Athens
Athens, Greece, 17237
Aristotle University of Thessaloniki
Thessaloniki, Greece, 54124
Sponsors and Collaborators
Aristotle University Of Thessaloniki
National and Kapodistrian University of Athens
European University Cyprus
Investigators
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Study Director: Michalis Nikolaidis, PhD Aristotle University Of Thessaloniki

Publications:
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Responsible Party: Vassilis Paschalis, Assistant Professor, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03121222     History of Changes
Other Study ID Numbers: 83022/2015
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes