Investigating the effect of concurrent training and L-Arginine supplementation on SIRT6, FBS and body composition in elderly men
Design
44 elderly non-athlete men will be divided into four groups [Exercise +Supplement (ES) group; Exercise +Placebo (EP) group; Supplement (S) group and Control (C) group], in the form of randomized, controlled clinical trial with a parallel group design and blinded outcome assessment.
Settings and conduct
The exercise protocol of this study will be conducted in a sports club, under the supervision of a physician, researcher and trainer in this field. In this study, blinding will be done in the information gathering stage by a person who is completely unaware of the presence of individuals in the groups.
Participants/Inclusion and exclusion criteria
44 elderly non-athlete men will be selected. The inclusion criteria are as follows: male gender, 60≤age≤75 years, no systematic strength training last 6 months,Written willingness and informed consent to participate in the study. Exclusion criteria were: Orthopedic, cardiovascular and respiratory problems, disability to do strength training, consumed of antioxodant supplement.
Intervention groups
subjects will be randomly divided into four equal-sized groups; Exercise +Supplement (ES) group; Exercise +Placebo (EP) group; Supplement (S) group and Control (C) group.
Main outcome variables
Rate of sirt6
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180912041018N2
Registration date:2019-02-10, 1397/11/21
Registration timing:registered_while_recruiting
Last update:2019-02-10, 1397/11/21
Update count:0
Registration date
2019-02-10, 1397/11/21
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
2018-02-20, 1396/12/01
Expected recruitment end date
2019-04-17, 1398/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the Effect of Concurrent Training and Supplementation of L-Arginine on SIRT6, FBS and Body Composition in Elderly men
Public title
Study the Effect of Exercise Training and Supplementation of L-Arginine in elderly men
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
males in range of 60≤age≤75 years
Being able to do exercise movements
Exclusion criteria:
Having systematic strength training last 6 months (At least more than one session per week)
having to cardiovascular disease and joint and bone problems
Bone fractures
Use of any kind of antioxidant supplements
Age
From 60 years old to 75 years old
Gender
Male
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
44
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Using NCSS PASS11 software, Procedure menu, DOE submenu, subjects were randomly will be divided into four equal-sized groups
Blinding (investigator's opinion)
Single blinded
Blinding description
Since Exercise training cannot be masked in a way as, for instance, pharmacological substances, so an important level of blinding in exercise science research remains with the data collectors. In this single-blind study, due to the nature of the method, blinding will be done in the information gathering stage by a person who is completely unaware of the presence of individuals in the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Tabriz University of Medical Sciences
Street address
Niayesh
City
tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-03-05, 1396/12/14
Ethics committee reference number
IR.TBZMED.REC.1396.1136
Health conditions studied
1
Description of health condition studied
aging
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sirtuin-6
Timepoint
Measuring Sirtuin-6 in the start of the study and 48 hours after the last training session
Method of measurement
Sirtuin6 concentrations assaye in plasma according to the manufacturers’ instructions using ELISA kits specific for human
2
Description
Glucose
Timepoint
Measuring Glucose in the start of the study and 48 hours after the last training session
Method of measurement
برای اندازه گیری گلوکز خون ازروش آنزیماتیک کالری متری و کیت شرکت پارس آزمون ایران و به ترتیب با دقت و حساسیت 1.3 % و 1 mg/dl استفاده خواهد شد
3
Description
Body Composition
Timepoint
Measuring Body Composition in the start of the study and 48 hours after the last training session
Method of measurement
Body Composition will be calculated as weight (kg) divided by the square of the height (m2)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First group of concurrent training+ supplement of l-arginine that in addition to the concurrent training, performed three sessions per week (coupled days), daily each subject received 1,000 mg of L-Arg capsule contain of L-arginine Hydrochloride, Microcrystalline Cellulose, P.V.P, Magnesium, Stearate after breakfast with full stomach.
Category
Rehabilitation
2
Description
Intervention group: secound, group of concurrent training+placebo, which in addition to implementing the exercise protocol three sessions per week for eight weeks, will also use placebo capsules similar to capsules of supplementary groups filled with maltodextrin. It should be noted that the investigator and subjects will not be informed of the contents of the capsule until the end of the protocol.
Category
Placebo
3
Description
Intervention group: Third, group of supplement that for eight weeks, daily received 1,000 mg of placebo capsules .The capsules will have identical shape and appearance and contained L-Arg Hydrochloride, Microcrystalline Cellulose, P.V.P, Magnesium, Stearate (Karen Pharma & Food Supplement Co) Prepared from Karen Pharmaceutical Company PNC, code 6261405113328 approved by the Ministry of Health of Iran.
Category
Other
4
Description
Control group: There was no intervention on them, only they were asked to continue their normal life
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahreza Nursing Home
Full name of responsible person
Neda Gilani
Street address
Pasdaran
City
Shahreza
Province
Isfehan
Postal code
۸۶۵۶۱۱۱۱۱۱
Phone
+98 31 5351 5661
Email
khaneyemehr2@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Niayesh
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
info@pharmfac-en.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
60
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
Tabriz University of Medical Sciences
Full name of responsible person
Neda Gilani
Position
Assistant Professor of Biostatistics
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Niayesh, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0308
Email
neda.gilani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Rouhollah Haghshenas
Position
Assistant Professor of exercise physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
standard square
City
Semnan
Province
Semnan
Postal code
3513119111
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
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Standard Squer
City
semnan
Province
Semnan
Postal code
3513119111
Phone
+98 233363494
Email
rhm@semnan.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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 SPSS data used to support the findings of this study are available from the corresponding author upon request.
When the data will become available and for how long
The SPSS data used to support the findings of this study are available from the corresponding author upon request.
To whom data/document is available
The SPSS data used to support the findings of this study are available from the corresponding author upon request.
Under which criteria data/document could be used
By authorizing the corresponding author and maintaining all the material and spiritual rights
From where data/document is obtainable
The SPSS data used to support the findings of this study are available from the corresponding author upon request.
What processes are involved for a request to access data/document
The SPSS data used to support the findings of this study are available from the corresponding author upon request.