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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
Nicolaus Copernicus University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 28, 2018
    Last Updated
    April 20, 2018
    Sponsor
    Nicolaus Copernicus University
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    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.

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

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