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The interaction effect of aerobic exercise and vitamin D supplementation on serum levels of apelin, vaspin and inflammatory factors in postmenopausal women with metabolic syndrome

Protocol summary

Study aim
Evaluation of the interactional effect of aerobic exercise and vitamin D supplementation on serum levels of apelin, vaspin and inflammatory factors in postmenopausal women with metabolic syndrome
Design
For this purpose, 48 postmenopausal women with metabolic syndrome will be randomly divided into four groups: aerobic training+ vitamin D supplementation, aerobic training, vitamin D supplementation and control. Supplementation included approximately 50,000 IU or placebo per week for eight weeks. The aerobic training protocol includes 40 to 60 minutes of aerobic exercise with a maximum intensity of 60 to 75% of the heart rate maximum, 3 times a week for eight weeks.
Settings and conduct
This clinical trial study will be conducted on the effects of aerobic training with Vit D supplementation on metabolic syndrome patients of Kermanshah in pre-test and post-test form, under the supervision of the Faculty of Physical Education of Sanandaj Branch of Azad University
Participants/Inclusion and exclusion criteria
Inclusion criteria will include evaluation of metabolic syndrome based on ATPIII criteria, being in menopause age, 25-OHD serum levels between 10 and 20 ng/ml, not having a specific diet and regular exercise program in the past year. Exclusion criteria include; presence of other cardiovascular disease, surgical treatment of obesity or severe weight loss, and the presence of any other chronic disease or skeletal disorders
Intervention groups
Aerobic training (placebo); Vitamin D supplementation (no AT); Aerobic training with vitamin D supplements (AT+Vit D); and Control (placebo+no AT)
Main outcome variables
levels of vitamin D, lipid profile, body composition, blood pressure, insulin, glucose, vaspin, apelin, interleukin-6, interleukin beta-1, tumor necrosis factor alpha, C- reactive protein

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200122046217N1
Registration date: 2020-08-14, 1399/05/24
Registration timing: retrospective

Last update: 2020-08-14, 1399/05/24
Update count: 0
Registration date
2020-08-14, 1399/05/24
Registrant information
Name
Parivash Najafi nazar abadi
Name of organization / entity
No.9, Adab Ave, Pasdaran Blvd, Islamic Azad University Sanandaj Branch
Country
Iran (Islamic Republic of)
Phone
+98 87 3328 8661
Email address
pnajafi1354@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-10, 1399/04/20
Expected recruitment end date
2020-08-10, 1399/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The interaction effect of aerobic exercise and vitamin D supplementation on serum levels of apelin, vaspin and inflammatory factors in postmenopausal women with metabolic syndrome
Public title
The effect of exercise and vitamin D in postmenopausal women with metabolic syndrome
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
confirmation of metabolic syndrome based on ATPIII criteria Not having a specific diet and regular exercise program in the past year 25-OHD serum levels between 10 and 20 ng/ml Being in menopause age
Exclusion criteria:
Presence of other cardiovascular disease Surgical treatment of obesity Presence of any other chronic disease or skeletal disorders severe weight loss
Age
From 50 years old to 60 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, a table of random numbers will be used for randomization. In which subjects are randomly assigned to separate groups to compare the effects of intervention methods.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
No. 8, Pasdaran Blvd, Sanandaj Province, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617913446
Approval date
2020-01-07, 1398/10/17
Ethics committee reference number
IR.MUK.REC.1398.241

Health conditions studied

1

Description of health condition studied
Metabolic syndrome disease
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome

Primary outcomes

1

Description
Vitamin D levels
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By blood sampling

2

Description
Anthropometric indices
Timepoint
Before the study starts and after the study ends
Method of measurement
Using INBODY test

3

Description
Lipid profile
Timepoint
Before the study starts and after it ended.
Method of measurement
Blood sampling

4

Description
Vaspin
Timepoint
Before the study starts and after it ended.
Method of measurement
Blood sampling

5

Description
Apelin
Timepoint
Before the study starts and after it ended.
Method of measurement
Blood sampling

6

Description
interleukin-6
Timepoint
Before the study starts and after it ended.
Method of measurement
Blood sampling

7

Description
Interleukin beta-1
Timepoint
Before the study starts and after it ended.
Method of measurement
Blood sampling

8

Description
C- reactive protein
Timepoint
Before the study starts and after it ended.
Method of measurement
Blood sampling

9

Description
Tumor necrosis factor alpha
Timepoint
Before the study starts and after it ended.
Method of measurement
Blood sampling

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The aerobic training + vitamin D supplementation Intervention will be consists of 20-40 minutes of aerobic exercise at 60% - 75% of HRmax, 3 times a week for eight weeks and vitamin D supplementation will be receiving vitamin D (∼50000 IU • week for eight weeks).
Category
Lifestyle

2

Description
Intervention group: Aerobic training consists of 20-40 minutes of aerobic exercise at 60% - 75% of HRmax, 3 times a week for eight weeks.
Category
Lifestyle

3

Description
Intervention group: Vitamin D supplementation includes receiving vitamin D (∼50000 IU • week for eight weeks).
Category
Lifestyle

4

Description
Control group: receiving placebo and no aerobic training for eight weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Ali hospital
Full name of responsible person
Parivash Najafi Nazar Abadi
Street address
Shahid Beheshti Blvd. - Imam Ali Cardiovascular Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847145
Phone
+98 83 3836 0295
Fax
+98 83 3836 0043
Email
pnajafi1354@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zaher Etemad
Street address
No. 9, Faculty of Physical Education and Sports Sciences, Sanandaj, Adab St., Daneshgah Blvd., Islamic Azad University, Sanandaj Branch
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8661
Email
zaher.etemad2020@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
slamic Azad University, Sanandaj Branch
Proportion provided by this source
10
Public or private sector
Private
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
Razi University
Full name of responsible person
Rastegar Hoseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3427 7605
Email
R.hoseini@razi.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University
Full name of responsible person
Rastegar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
009834279265
Email
R.hoseini@razi.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Sanandaj Branch
Full name of responsible person
Parivash Najafi Nazar Abadi
Position
PhD Student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 9, Faculty of Physical Education and Sports Sciences, Sanandaj, Adab St., Daneshgah Blvd., Islamic Azad University, Sanandaj Branch
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 66 1693 5391
Email
pnajafi1354@gmail.com

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
All data will be record in the SPSS software and will be available.
When the data will become available and for how long
Availability will start nine months after publishing all papers
To whom data/document is available
Only available for researchers in academic and scientific institutions
Under which criteria data/document could be used
All data can be used as reference
From where data/document is obtainable
pnajafi1354@gmail.com
What processes are involved for a request to access data/document
If the explanation for data request would be convincing it will be given in 3 days.
Comments
not having any
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