AntioxidantsNCT03505411
The Influence of Melatonin Supplementation in the Group of Persons Performing Competitive Sport.
A study testing melatonin supplementation in people with Antioxidants and Oxidative Stress, run by Nicolaus Copernicus University.
Trial summary
The research aims to determine the impact of 30-day supplementation of melatonin on the antioxidative defense mechanisms and the release of markers of oxidative stress and inflammation in rowers and footballers undergoing training of submaximal intensity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antioxidants, Oxidative Stress, Inflammation
- What is being tested?
- melatonin supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2010to 31 Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sign informed consent form for participation in the study
Who cannot join
- diseases
- the participants will not be minor and incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators
About this study
The research aims to determine the impact of 30-day supplementation of melatonin on the antioxidative defense mechanisms and the release of markers of oxidative stress and inflammation in rowers and footballers undergoing training of submaximal intensity.
Read the detailed description
Athlete's body, by its high oxygen demand and increased aerobic metabolism, is exposed to the formation and oxidizing action of reactive oxygen species (ROS). Imbalance between the mechanisms of ROS generation and antioxidative defense of the body can lead to oxidative stress expressed by elevated concentrations of lipid peroxidation products, such as malondialdehyde, isoprostanes (8-iso-PGF2α), oxidized low-density lipoprotein molecules (ox-LDL). The body's defense against ROS includes two systems: nonenzymatic and enzymatic. Small-molecule antioxidants include reduced glutathione (GSH). Due to the presence of -SH groups, glutathione has strong reductive properties. The compound is a substrate for glutathione peroxidase (GSH-Px) which decomposes hydrogen peroxide and organic peroxides. Among antioxidant enzymes are also: superoxide dismutase (Cu-Zn-SOD, scavenges superoxide anion radical), catalase (CAT, reduces hydrogen peroxide), and glutathione reductase (GR, reduces oxidized glutathione). Another well-known small-molecule antioxidant is melatonin, hormone of the pineal gland. It has been demonstrated that this compound can reduce hydrogen peroxide, scavenge hydroxyl radical and deactivate nitric oxide radical.
Another manifestation of disruption of homeostasis in the body of a professional athlete are enhanced inflammatory processes. This can be explained by the fact that during physical effort of varied intensity, increased activity of myeloperoxidase and higher levels of mRNA for tumor necrosis factor, interleukin-1 and -6 are observed. Interleukin-6, also known as myokine, is a particularly important marker of intense physical effort released from damaged muscles. Myokine is also the main upregulator of the synthesis of C-reactive protein (CRP) in the liver, hence measuring the concentration of the protein can indicate the intensity of inflammatory processes in an athlete's body. It has been demonstrated that melatonin, in addition to its hormonal and antioxidant properties, can modulate inflammatory processes by reducing the synthesis of proinflammatory cytokines.
Taking into account the multidirectional function of melatonin, it seems interesting to establish the impact of 30-day supplementation of this hormone on the antioxidative defense mechanisms and the release of markers of oxidative stress and inflammation in rowers and footballers undergoing training of submaximal intensity.
- Conditions
- Antioxidants, Oxidative Stress, Inflammation, Lipid Peroxidation
- Being tested
- melatonin supplementation
- Keywords
- Melatonin, Glutathione, Glutathione peroxidase, Malondialdehyde, Isoprostanes, anti-ox-LDL, Superoxide dismutase, Glutathione reductase, Interleukin-6, C-reactive protein, Autonomic nervous system
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatonin supplementationDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| melatonin, submaximal effort | Experimental | 1 arm 5 mg melatonin 1 hr before bedtime for 30 days Receives: Dietary Supplement: melatonin supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of oxidative stress parameters and inflammatory markers concentration before melatonin administration, at baseline.
The study was conducted in football players and rowers and the control group. Samples of blood from the basilic vein were taken once, from both the control group and the athletes at baseline. In blood serum, the ELISA method was used to determine the concentrations of melatonin, isoprostanes (8-iso-PGF2α), anti-ox-LDL antibodies, interleukin-6 and C-reactive protein (CRP). In red blood cells, the concentration of reduced glutathione (GSH), thiobarbituric acid reactive substances (malondialdehyde, MDA) were determined and the activity of glutathione peroxidase (GSH-Px), cytoplasmic superoxide dismutase (SOD-1) and glutathione reductase (GR) were determined.
Measured: 1 day
Secondary outcomes (1)
Changes in oxidative stress parameters and inflammatory markers concentration afer 30 days of melatonin administration in athletes.
After 30 days of melatonin supplementation, samples of blood from the basilic vein were taken only from athletes, once, in the same day. In biochemistry laboratory, in blood serum, the ELISA method was used to determine the concentrations of melatonin, isoprostanes (8-iso-PGF2α), anti-ox-LDL antibodies, interleukin-6 and C-reactive protein (CRP). In red blood cells, the concentration of reduced glutathione (GSH), thiobarbituric acid reactive substances (malondialdehyde, MDA) were determined and the activity of glutathione peroxidase (GSH-Px), cytoplasmic superoxide dismutase (SOD-1) and glutathione reductase (GR) were determined.
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start15 Jan 2010
- Primary completion31 Dec 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntioxidantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolanta Czuczejko, Nicolaus Copernicus University
- Investigators
- Jolanta Czuczejko, Principal investigator, Department of Positron Emission Tomography and Molcecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505411
- Sponsor's protocol ID
- KB 586/2009
- Status last verified
- Mar 2018
- First submitted
- 28 Mar 2018
- Last updated
- 23 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no the IPD sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Melatonin Supplementation in the Group of Persons Performing Competitive Sport.
- ClinicalTrials.gov ID
- NCT03505411
- Acronym / sponsor ID
- KB 586/2009
- Conditions
- Antioxidants, Oxidative Stress, Inflammation, Lipid Peroxidation
- Keywords
- Melatonin, Glutathione, Glutathione peroxidase, Malondialdehyde, Isoprostanes, anti-ox-LDL, Superoxide dismutase, Glutathione reductase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Study start
- 15 Jan 2010 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research aims to determine the impact of 30-day supplementation of melatonin on the antioxidative defense mechanisms and the release of markers of oxidative stress and inflammation in rowers and footballers undergoing training of submaximal intensity.
Detailed description
Athlete's body, by its high oxygen demand and increased aerobic metabolism, is exposed to the formation and oxidizing action of reactive oxygen species (ROS). Imbalance between the mechanisms of ROS generation and antioxidative defense of the body can lead to oxidative stress expressed by elevated concentrations of lipid peroxidation products, such as malondialdehyde, isoprostanes (8-iso-PGF2α), oxidized low-density lipoprotein molecules (ox-LDL). The body's defense against ROS includes two systems: nonenzymatic and enzymatic. Small-molecule antioxidants include reduced glutathione (GSH). Due to the presence of -SH groups, glutathione has strong reductive properties. The compound is a substrate for glutathione peroxidase (GSH-Px) which decomposes hydrogen peroxide and organic peroxides. Among antioxidant enzymes are also: superoxide dismutase (Cu-Zn-SOD, scavenges superoxide anion radical), catalase (CAT, reduces hydrogen peroxide), and glutathione reductase (GR, reduces oxidized glutathione). Another well-known small-molecule antioxidant is melatonin, hormone of the pineal gland. It has been demonstrated that this compound can reduce hydrogen peroxide, scavenge hydroxyl radical and deactivate nitric oxide radical.
Another manifestation of disruption of homeostasis in the body of a professional athlete are enhanced inflammatory processes. This can be explained by the fact that during physical effort of varied intensity, increased activity of myeloperoxidase and higher levels of mRNA for tumor necrosis factor, interleukin-1 and -6 are observed. Interleukin-6, also known as myokine, is a particularly important marker of intense physical effort released from damaged muscles. Myokine is also the main upregulator of the synthesis of C-reactive protein (CRP) in the liver, hence measuring the concentration of the protein can indicate the intensity of inflammatory processes in an athlete's body. It has been demonstrated that melatonin, in addition to its hormonal and antioxidant properties, can modulate inflammatory processes by reducing the synthesis of proinflammatory cytokines.
Taking into account the multidirectional function of melatonin, it seems interesting to establish the impact of 30-day supplementation of this hormone on the antioxidative defense mechanisms and the release of markers of oxidative stress and inflammation in rowers and footballers undergoing training of submaximal intensity.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| melatonin, submaximal effort | Experimental | Dietary Supplement: melatonin supplementation1 arm 5 mg melatonin 1 hr before bedtime for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- sign informed consent form for participation in the study
Key exclusion criteria (2 listed)
- diseases
- the participants will not be minor and incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatonin supplementation | Dietary supplement | melatonin, submaximal effort |
Primary outcome
Measurement of oxidative stress parameters and inflammatory markers concentration before melatonin administration, at baseline.
Time frame: 1 day
The study was conducted in football players and rowers and the control group. Samples of blood from the basilic vein were taken once, from both the control group and the athletes at baseline. In blood serum, the ELISA method was used to determine the concentrations of melatonin, isoprostanes (8-iso-PGF2α), anti-ox-LDL antibodies, interleukin-6 and C-reactive protein (CRP). In red blood cells, the concentration of reduced glutathione (GSH), thiobarbituric acid reactive substances (malondialdehyde, MDA) were determined and the activity of glutathione peroxidase (GSH-Px), cytoplasmic superoxide dismutase (SOD-1) and glutathione reductase (GR) were determined.
1 secondary outcome
Changes in oxidative stress parameters and inflammatory markers concentration afer 30 days of melatonin administration in athletes.
Time frame: 30 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Individual participant dataSharing planned: No. There is no the IPD sharing plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolanta Czuczejko principal investigator
Department of Positron Emission Tomography and Molcecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University
Questions about this trial
What is this clinical trial studying?
A study testing melatonin supplementation in people with Antioxidants and Oxidative Stress, run by Nicolaus Copernicus University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of oxidative stress parameters and inflammatory markers concentration before melatonin administration, at baseline. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.