Glutathione Metabolism Anemias Clinical Trial
Official title:
N-acetylcysteine Supplementation in Individuals With Low Glutathione Levels: the Effects on Physical Performance and Redox Homeostasis
| Verified date | April 2017 |
| Source | Aristotle University Of Thessaloniki |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | September 12, 2016 |
| Est. primary completion date | February 15, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 29 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Cyprus | European University Cyprus | Nicosia | |
| Greece | National and Kapodistrian University of Athens | Athens | |
| Greece | Aristotle University of Thessaloniki | Thessaloniki |
| Lead Sponsor | Collaborator |
|---|---|
| Aristotle University Of Thessaloniki | European University Cyprus, National and Kapodistrian University of Athens |
Cyprus, Greece,
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Paschalis V, Theodorou AA, Kyparos A, Dipla K, Zafeiridis A, Panayiotou G, Vrabas IS, Nikolaidis MG. Low vitamin C values are linked with decreased physical performance and increased oxidative stress: reversal by vitamin C supplementation. Eur J Nutr. 2016 Feb;55(1):45-53. doi: 10.1007/s00394-014-0821-x. Epub 2014 Dec 20. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measurement of maximal oxygen consumption (ml/kg/min) | 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. |
64 days | |
| Secondary | Measurement of glutathione levels (µmol/g Hb) | 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. |
64 days |