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The Protective Effect of Aerobic Training with Salvia officinalis Consumption on Endothelial Function Indices in Postmenopausal Women

Protocol summary

Study aim
The aim of this study is to compare the effect of aerobic exercise, Salvia officinalis and their combination on the serum levels of Intercellular adhesion molecule (ICAM)-1, Soluble vascular cellular adhesion molecule 1 (sVCAM-1) and Endothelin-1 in Postmenopausal Women.
Design
This clinical trial study with a control group and a blind strain will be conducted in phase 3 on 32 postmenopausal women who are randomly selected. To place people in each group, Simple randomization by random allocation rule (balloting container and separate papers) is used.
Settings and conduct
The research site is Hejab Sports Club, Amol City. Since the exercise training did not have the ability to be blinded, the present study was performed in an unblinded manner. However, supplementation is blinded.
Participants/Inclusion and exclusion criteria
Being menopausal, Age range 50-65 years, inactive lifestyle, no drug use in the previous 6 months, and consent to participate in the study
Intervention groups
Control group: in this group we have not any intervention during 8 weeks, and will consider this group as placebo. Training group (This group performs aerobic exercise with an intensity of 40-80% of the maximum reserve heart rate for 8 weeks, three sessions a week). Salvia officinalis supplement group (this group receives three tablets of 100 mg of So orally daily). Training+ Salvia officinalis supplementation group (In this group the Simultaneous intervention, training and Salvia officinalis supplementation, will treat with the same protocol that describe at the previous part).
Main outcome variables
Adhesion indexes such as: Intercellular adhesion molecule (ICAM-1), Soluble vascular cellular adhesion molecule 1 (sVCAM-1).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140415017288N10
Registration date: 2023-02-14, 1401/11/25
Registration timing: prospective

Last update: 2023-02-14, 1401/11/25
Update count: 0
Registration date
2023-02-14, 1401/11/25
Registrant information
Name
Ahmad Abdi
Name of organization / entity
Ayatollah Amoli Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 11 4321 7126
Email address
a.abdi@iauamol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-06-05, 1402/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Protective Effect of Aerobic Training with Salvia officinalis Consumption on Endothelial Function Indices in Postmenopausal Women
Public title
Effect of Exercise and Salvia officinalis on Postmenopausal Women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Being menopausal Age range 50-65 years Inactive lifestyle (exercise less than 1 hour per week) Do not use the drug in 6 months Satisfaction to participate in the study
Exclusion criteria:
Supplement use Diagnosis of other underlying diseases during the implementation of the protocol Not taking Salvia officinalis Use of estrogen and other androgens and steroids that affect estrogen receptors
Age
From 50 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 32
More than 1 sample in each individual
Number of samples in each individual: 8
Postmenopausal Women
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, subjects are selected Simple randomization by random allocation rule. After determining the sample size (32 people), numbers 1 to 4 are written on 32 small separate papers (8 sheets of paper for each number) and placed in a container. The number 1 is for the Placebo Control group (C), the number 2 is for the Aerobic Training group (AT), the number 3 is for the Salvia officinalis group (So) and the number 4 is for the Training-Salvia officinalis (ATSo). Then each sheet of paper is randomly taken out by the subjects and placed in the intervention or placebo groups, respectively.
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 Islamic Azad University - Marvdasht Branch
Street address
3 km of Marvdasht-Persepolis Boulevard, Islamic Azad University, Marvdasht Branch
City
Marvdasht
Province
Fars
Postal code
13119-73711
Approval date
2022-11-26, 1401/09/05
Ethics committee reference number
IR.IAU.M.REC.1401.031

Health conditions studied

1

Description of health condition studied
Postmenopausal Women
ICD-10 code
N95.9
ICD-10 code description
Unspecified menopausal and perimenopausal disorder

Primary outcomes

1

Description
Intercellular adhesion molecule (ICAM)-1
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods (by ELISA method)

2

Description
Soluble vascular cellular adhesion molecule 1 (sVCAM-1)
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods (by ELISA method)

Secondary outcomes

1

Description
Endothelin-1 (ET-1)
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods (by ELISA method)

2

Description
E-selectin
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods (by ELISA method)

3

Description
Nitric Oxide (NO)
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods (by ELISA method)

Intervention groups

1

Description
Control group: This group received three 100 mg starch tablets as a placebo during the 8-week intervention period.
Category
Placebo

2

Description
Intervention group 1: Training group (in this group for eight-week, three session/weeks, the training start with 10 min warming and then 25 to 45 min training with 40% Maximum heart rate reserve, which in the final weeks reaches 80% of the Maximum heart rate reserve. Also, this group received three 100 mg starch tablets as a placebo during the 8-week intervention period).
Category
Treatment - Other

3

Description
Intervention group 2: Intervention group: Salvia officinalis supplement group (this group receives three tablets of 100 mg of So orally daily).
Category
Treatment - Other

4

Description
Intervention group 3: Training+ Salvia officinalis supplementation group (In this group the Simultaneous intervention, training and Salvia officinalis supplementation, will treat with the same protocol that describe at the previous part).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Amoli Branch, Islamic Azad University
Full name of responsible person
Ahmad Abdi
Street address
Old Amol-Babol road, Kamdereh village- Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7124
Fax
+98 11 4321 7009
Email
a.abdi@iauamol.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Asieeh Abbassi Daloii
Street address
Old Amol-Babol road, Kamdereh village- Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7124
Fax
+98 11 4321 7009
Email
abbasi.daloii@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
100
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
Islamic Azad University
Full name of responsible person
Ahmad Abdi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Old Amol-Babol road - Kamdara village - Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7124
Email
a.abdi@iauamol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Barari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Old Amol Babol road - Kamdara village - Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7126
Email
alireza54.barari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Abdi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Old Amol-Babol road - Kamdara village - Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7124
Email
a.abdi@iauamol.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Information on the main outcomes will be shared.
When the data will become available and for how long
Since 2023
To whom data/document is available
All researchers
Under which criteria data/document could be used
If people email the person responsible for the plan, they can get the desired documents in the form of a file. (a.abdi58@gmail.com-09113001960)
From where data/document is obtainable
People can apply for documents through email.
What processes are involved for a request to access data/document
Maximum one week
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