NCT03505411

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2012

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
Last Updated

April 23, 2018

Status Verified

March 1, 2018

Enrollment Period

3 years

First QC Date

March 28, 2018

Last Update Submit

April 20, 2018

Conditions

Keywords

MelatoninGlutathioneGlutathione peroxidaseMalondialdehydeIsoprostanesanti-ox-LDLSuperoxide dismutaseGlutathione reductaseInterleukin-6C-reactive proteinAutonomic nervous system

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    30 day

Study Arms (1)

melatonin, submaximal effort

EXPERIMENTAL

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

Dietary Supplement: melatonin supplementation

Interventions

melatonin supplementationDIETARY_SUPPLEMENT
melatonin, submaximal effort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sign informed consent form for participation in the study

You may not qualify if:

  • diseases
  • the participants will not be minor and incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jolanta Czuczejko

    Department of Positron Emission Tomography and Molcecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 28, 2018

First Posted

April 23, 2018

Study Start

January 15, 2010

Primary Completion

December 31, 2012

Study Completion

December 31, 2012

Last Updated

April 23, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

There is no the IPD sharing plan.