The Influence of Melatonin Supplementation in the Group of Persons Performing Competitive Sport.
Primary Purpose
Antioxidants, Oxidative Stress, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
melatonin supplementation
Sponsored by

About this trial
This is an interventional prevention trial for Antioxidants focused on measuring Melatonin, Glutathione, Glutathione peroxidase, Malondialdehyde, Isoprostanes, anti-ox-LDL, Superoxide dismutase, Glutathione reductase, Interleukin-6, C-reactive protein, Autonomic nervous system
Eligibility Criteria
Inclusion Criteria:
- sign informed consent form for participation in the study
Exclusion Criteria:
- diseases
- the participants will not be minor and incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
melatonin, submaximal effort
Arm Description
1 arm 5 mg melatonin 1 hr before bedtime for 30 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03505411
First Posted
March 28, 2018
Last Updated
April 20, 2018
Sponsor
Nicolaus Copernicus University
1. Study Identification
Unique Protocol Identification Number
NCT03505411
Brief Title
The Influence of Melatonin Supplementation in the Group of Persons Performing Competitive Sport.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 15, 2010 (Actual)
Primary Completion Date
December 31, 2012 (Actual)
Study Completion Date
December 31, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nicolaus Copernicus University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antioxidants, Oxidative Stress, Inflammation, Lipid Peroxidation
Keywords
Melatonin, Glutathione, Glutathione peroxidase, Malondialdehyde, Isoprostanes, anti-ox-LDL, Superoxide dismutase, Glutathione reductase, Interleukin-6, C-reactive protein, Autonomic nervous system
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
melatonin, submaximal effort
Arm Type
Experimental
Arm Description
1 arm 5 mg melatonin 1 hr before bedtime for 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
melatonin supplementation
Primary Outcome Measure Information:
Title
Measurement of oxidative stress parameters and inflammatory markers concentration before melatonin administration, at baseline.
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Changes in oxidative stress parameters and inflammatory markers concentration afer 30 days of melatonin administration in athletes.
Description
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.
Time Frame
30 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
sign informed consent form for participation in the study
Exclusion Criteria:
diseases
the participants will not be minor and incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jolanta Czuczejko
Organizational Affiliation
Department of Positron Emission Tomography and Molcecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no the IPD sharing plan.
Learn more about this trial
The Influence of Melatonin Supplementation in the Group of Persons Performing Competitive Sport.
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