Protocol summary

Study aim
The purpose of this study is to investigate the effect of eight weeks of selenium supplementation with concurrent training on SOD CAT, CRP, GPX and lipid profiles of elderly men.
Design
A clinical trial with a pre-test-post-test semi-experimental design with a control group, double-blind, phase 4 on 48 elderly men using the PASS 2023 software (NCSS, LLC, Kaysville, Utah, USA, ncss.com/software/pass ) the subjects will be divided into 6 parallel groups of 8 people and will be placed in one of the following groups: supplement, placebo, control, concurent training, concurent training+supplement, concurent training+placebo. The supplement groups will receive 200 micrograms of Selenium supplement with the American brand Naturemid. Maltodextrin will also be used as a placebo and in completely similar capsules as a placebo. The training program will be done 3 days a week on non-consecutive days for 8 weeks, each session will be 60 minutes in the morning.
Settings and conduct
This study will be conducted in Kahrizak home of Alborz province on the elderly in a double blind method (subjects, researchers and executive staff and data analyzers are not aware of the contents of the capsules until the end of extracting the results).
Participants/Inclusion and exclusion criteria
The criteria for inclusion in the study are elderly men with the age of at least 65 and at most 75 years, the ability to perform physical and daily activities, the absence of underlying diseases such as diabetes, cardiovascular disease, and skeletal and joint abnormalities.
Intervention groups
After selecting the subjects, 48 elderly men will be divided into 6 groups of 8 people: supplement, placebo, control, concurent training, concurent training group+supplement, concurent training+placebo.
Main outcome variables
Improving the condition of the elderly using a combination of supplements and exercise

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180912041018N3
Registration date: 2023-11-20, 1402/08/29
Registration timing: prospective

Last update: 2023-11-20, 1402/08/29
Update count: 0
Registration date
2023-11-20, 1402/08/29
Registrant information
Name
Rouhollah Haghshenas
Name of organization / entity
Semnan
Country
Iran (Islamic Republic of)
Phone
+98 23 3336 3494
Email address
rhm@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-10, 1402/10/20
Expected recruitment end date
2024-01-25, 1402/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of selenium supplementation and Concurrent training on SOD, CAT, CRP, GPX, GR and lipid profile in elderly men
Public title
Investigation of the effect of selenium and exercise on the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of the subjects should be between 65 and 75. Subjects must be able to perform daily activities and physical activity.
Exclusion criteria:
Use of antioxidant supplements up to 6 months before conducting the research Having chronic diseases, such as cardiovascular diseases, diabetes, acute joint disease, osteoporosis, bone fractures
Age
From 65 years old to 75 years old
Gender
Male
Phase
4
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
After finalizing the 48 subjects and assigning codes 1 to 48 to each subject individually and using the PASS 2023 software (NCSS, LLC, Kaysville, Utah, USA, ncss.com/software/pass), the subjects were will be randomly divided into 6 groups of 8 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
This research will be done in a double blind way. After explaining the conditions and how to conduct the research to the subjects, they will be divided into six groups. Supplemental group, placebo group, control group, concurrent training group, concurrent training+supplement group, concurrent training+placebo group. None of the participants, the executive staff of nurses, physiotherapists, etc., practitioners and students (researcher) will know about the contents of the capsules. Which group will use the supplement and which group will use the placebo, the subjects and the researcher will not know. And this work will be determined by a third party as a reference person. In this way, the capsules containing placebo and supplement will be coded and provided by the researcher to the specified groups. At the end of the research and after collecting the blood sample and measuring the dependent variables, the data will be collected and provided to the supervisor, and after the data analysis and the results are determined, the codes will be opened and the supplement and placebo groups will be determined.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan University of Medical Sciences and Health Services
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2023-07-31, 1402/05/09
Ethics committee reference number
IR.SEMUMS.REC.1402.100

Health conditions studied

1

Description of health condition studied
Aging
ICD-10 code
Z10
ICD-10 code description
Factors influencing health status and contact with health services, Routine general health check-up of defined subpopulation,

Primary outcomes

1

Description
Glutathione peroxidase
Timepoint
Measurement of glutathione peroxidase at the beginning of the study (before the start of the intervention) and 48 hours after the last training session.
Method of measurement
By ELISA method and using ELISA kit

2

Description
Glutathione reductase
Timepoint
Measurement of Glutathione reductase at the beginning of the study (before the start of the intervention) and 48 hours after the last training session.
Method of measurement
by ELISA method and using ELISA kit

3

Description
C Reactive Protein
Timepoint
Measurement of C-reactive protein at the beginning of the study (before the start of the intervention) and 48 hours after the last training session and in the fasting state.
Method of measurement
By ELISA method and using ELISA kit

4

Description
Superoxide Dismutase
Timepoint
At the beginning of the study (before the start of the intervention) and 48 hours after the last training session and in the fasting state.
Method of measurement
By ELISA method and using ELISA kit

5

Description
Catalase
Timepoint
At the beginning of the study (before the start of the intervention) and 48 hours after the last training session and in the fasting state.
Method of measurement
By ELISA method and using ELISA kit

Secondary outcomes

1

Description
low-density lipoproteins
Timepoint
At the beginning of the study (before the start of the intervention) and 48 hours after the last training session and fasting state
Method of measurement
ELISA method and use of ELISA kit

2

Description
very low density lipoprotein
Timepoint
At the beginning of the study (before the start of the intervention) and 48 hours after the last training session and fasting state
Method of measurement
ELISA method and use of ELISA kit

3

Description
Cholesterol
Timepoint
At the beginning of the study (before the start of the intervention) and 48 hours after the last training session and fasting state
Method of measurement
ELISA method and use of ELISA kit

4

Description
Triglyceride
Timepoint
At the beginning of the study (before the start of the intervention) and 48 hours after the last training session and fasting state
Method of measurement
ELISA method and use of ELISA kit

Intervention groups

1

Description
Intervention group 1: Concurrent training, 3 sessions per week, 60 minutes in the morning, strength and endurance training protocol will be performed on every other day and on even days.
Category
Rehabilitation

2

Description
Intervention group 2: Supplement who will consume 200 micrograms of Selenium supplement with Nature med brand made in the USA.
Category
Other

3

Description
Intervention group 3: Concurrent training and supplementation, in addition to implementing the weekly Concurrent training protocol, three sessions of 60 minutes per session will consume 200 micrograms of selenium supplement daily.
Category
Rehabilitation

4

Description
Intervention group 4: Placebo, who will consume a capsule containing roasted wheat flour and similar to the capsule containing selenium.
Category
Placebo

5

Description
Intervention group 5: Exercise and placebo, in addition to implementing the Concurrent training protocol three sessions a week, each session will take 60 minutes a day, a capsule containing a placebo (roasted wheat flour) and completely similar to the selenium capsule.
Category
Placebo

6

Description
Control group: The control will have the same conditions as the other groups and will not receive any of the interventions.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran, Karaj, Kehrizak Nursing Home, Alborz Province
Full name of responsible person
Ali Nowrozi
Street address
at the beginning of Esfahani Street, at the end of Golstanak St, Mohammadshahr
City
Karaj
Province
Alborz
Postal code
31845-167
Phone
+98 26 3630 9171
Fax
+98 26 3630 1859
Email
Kahraj@kahrizak.com
Web page address
https://kahrizakcharity.com/kahrizak-alborz-intro

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University
Full name of responsible person
Rouhollah Haghshenas
Street address
5 km of Damghan road
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3153 0000
Email
rhm@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Rouhollah Haghshenas
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
5 km of Damghan road
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
0098 23 3342194
Email
rhm@semnan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Rouhollah Haghshenas
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Standard Square
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3336 3494
Email
rhm@semnan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Rouhollah Haghshenas
Position
Associte professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Standard Square
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3336 2194
Email
rhm@semnan.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the main outcomes will be published as articles in journals.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For use in review articles and meta-analysis
From where data/document is obtainable
Rouhollah Haghshenas, Email: rhm@semnan.ac.ir
What processes are involved for a request to access data/document
One week after the applicant's request and necessary checks, the necessary information will be sent via email.
Comments
Loading...