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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Oxidative Stress; Antioxidants; Lipid Peroxidation
• Intervention / Treatment: Dietary supplement: melatonin supplementation

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2010
• Primary Completion (Actual): December 31, 2012
• Study Completion (Actual): December 31, 2012

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2018
• Last Update Submitted That Met QC Criteria: April 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Melatonin; Malondialdehyde; Isoprostanes; Autonomic nervous system; C-reactive protein; Glutathione; Interleukin-6; Glutathione peroxidase; Superoxide dismutase; anti-ox-LDL; Glutathione reductase
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: KB 586/2009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no the IPD sharing plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No