The Influence of Melatonin Supplementation in the Group of Persons Performing Competitive Sport.

Sponsor

Nicolaus Copernicus University (Other)

Overall Status

Completed

CT.gov ID

NCT03505411

Collaborator

(none)

Enrollment

Arm

35.5

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Antioxidants Oxidative Stress Inflammation Lipid Peroxidation	Dietary Supplement: melatonin supplementation	N/A

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

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Actual Study Start Date :

Jan 15, 2010

Actual Primary Completion Date :

Dec 31, 2012

Actual Study Completion Date :

Dec 31, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: melatonin, submaximal effort 1 arm 5 mg melatonin 1 hr before bedtime for 30 days	Dietary Supplement: melatonin supplementation

Arm

Intervention/Treatment

Experimental: melatonin, submaximal effort

1 arm 5 mg melatonin 1 hr before bedtime for 30 days

Dietary Supplement: melatonin supplementation

Outcome Measures

Primary Outcome Measures

Measurement of oxidative stress parameters and inflammatory markers concentration before melatonin administration, at baseline. [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.

Secondary Outcome Measures

Changes in oxidative stress parameters and inflammatory markers concentration afer 30 days of melatonin administration in athletes. [30 day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nicolaus Copernicus University

Investigators

Principal Investigator: Jolanta Czuczejko, Department of Positron Emission Tomography and Molcecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University