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The effects of progressive resistance training with melatonin ingestion on antioxidant, inflammatory markers, and cardiovascular risk factors in overweight males

Protocol summary

Summary
The purpose of this study was to investigate the effect of 8 weeks progressive resistance training on antioxidant, inflammatory markers and cardiovascular disease in overweight men. Forty four overweight men were randomly assigned in four groups: (Group 1, melatonin without training (12 n), (CM), group 2, placebo training (12 n), (CP), group 3, melatonin with resistance training (12 n), (TM), and group 4, placebo resistance training (12 n), (TP)) in the summer 2017. The progressive resistance training performed three days a week with 55-85% IRM increasing intensity for eight weeks. Subjects of supplement group consumed 3 gr melatonin capsules, whiles other group consumed placebo for eight weeks daily, one hour before bedtime. Before and after the training period, blood samples were taken at 8 a.m. at the rest time, 48 to 72 hours after the last exercise session, after overnight fasting. Moreover, body composition indicators were measured in both stages.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017031333064N1
Registration date: 2017-08-02, 1396/05/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-02, 1396/05/11
Registrant information
Name
Mohammad Ghaderi
Name of organization / entity
Islamic Azad University,Mahabad Branch
Country
Iran (Islamic Republic of)
Phone
+98 44 4233 6000
Email address
m.ghaderi@iau-mahabad.ac.ir
Recruitment status
Recruitment complete
Funding source
Science and Research Branch, Islamic Azad University
Expected recruitment start date
2017-05-31, 1396/03/10
Expected recruitment end date
2017-08-11, 1396/05/20
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The effects of progressive resistance training with melatonin ingestion on antioxidant, inflammatory markers, and cardiovascular risk factors in overweight males
Public title
The effects of melatonin supplementation during resistance training on antioxidant, inflammatory and as a predictor of cardiovascular disease factors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Men, Overweight, aged 20-30 years; Body mass index (BMI) between 25 and 30; No current chronic health problems. Exclusion criteria: Smoking and Alcohol consumption; uncontrolled intake of any drug or supplement; being absent for three training sessions.
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Simple random method

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Clinical Research Ethics Committee of the Mahabad Islamic Azad University
Street address
Islamic Azad University, Mahabad Branch
City
Mahabad
Postal code
591393-3137
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
62/ع741

Health conditions studied

1

Description of health condition studied
cardiovascular disease risk factors
ICD-10 code
ICD-10 code description
other physical therapy

Primary outcomes

1

Description
Antioxidant factors (SOD,TAC), Oxidative stress (MDA), Inflammatory (CRP,IL-6) and Cardiovascular risk factors (LDL,HDL,CHOL. TG, LDL/HDL)
Timepoint
At the beginning of the study and prior of training and after training program
Method of measurement
Using specialized kits

Secondary outcomes

1

Description
Body composition indices
Timepoint
At the beginning of the study and prior of training and after training program
Method of measurement
At the beginning of the study and prior of training and after training program

Intervention groups

1

Description
The subjects in the training group were recommended to perform progressive resistance training three days a week with 55-85% IRM for eight weeks with melatonin ingestion.
Category
Lifestyle

2

Description
In the control group, participants were advised to maintain their normal lifestyle during the study
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Mahabad Branch
Full name of responsible person
Mohammad Ghaderi
Street address
Islamic Azad University, Mahabad Branch, Sports Complex
City
Mahabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Science and Research Branch
Full name of responsible person
Hossein Abed Natanzi
Street address
Science and Research Branch, Daneshgah Blvd, Simon Bulivar Blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Science and Research Branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University, Mahabad Branch
Full name of responsible person
Mohammad Ghaderi
Position
Ph.D. Candidate of Exercise Physiology
Other areas of specialty/work
Street address
Department of Physical Education and Sport Sciences, Mahabad Branch, Islamic Azad University
City
Mahabad
Postal code
591393-3137
Phone
+98 44 4233 6000
Fax
Email
m.ghaderi@iau-mahabad.ac.irm.ghaderi420@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Mahabad Branch
Full name of responsible person
Mohammad Ghaderi
Position
Ph.D. Candidate, Leacture
Other areas of specialty/work
Street address
Department of Physical Education and Sport Sciences, Mahabad Branch, Islamic Azad University
City
Mahabad
Postal code
591393-3137
Phone
+98 44 4233 6000
Fax
Email
m.ghaderi420@yahoo.comm.ghaderi@iau-mahabad.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University ,Mahabad Branch
Full name of responsible person
Mohammad Ghaderi
Position
Ph.D. Candidate
Other areas of specialty/work
Street address
Department of Physical Education and Sport Sciences, Mahabad Branch, Islamic Azad University
City
Mahabad
Postal code
591393-3137
Phone
+98 44 4233 6000
Fax
Email
m.ghaderi420@yahoo.comm.ghaderi@iau-mahabad.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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