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Preventive effects of Exercise Training and Salvia officinalis on Inflammation and Insulin Resistance 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 Inflammation and Insulin Resistance 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. For randomization, Simple randomization by random allocation rule is used. The sample size is calculated using GPower software. After selection, the subjects are randomly divided into four groups: Placebo Control (C), Aerobic Training (AT), Salvia officinalis (So), and Training-Salvia officinalis (ATSo).
Settings and conduct
Intervention Research, Amol City, The research site is Hejab Sports Club, which has already been coordinated. In this research, people who work with subjects are blinded.
Participants/Inclusion and exclusion criteria
Being menopausal, having the Age range of 50-65 years, inactive lifestyle (exercise less than 1 hour per week), Not taking medicine in the last 6 months, and being willing to participate in the study.
Intervention groups
Control group: in this group we have not had any intervention during 8 weeks and will consider this group as a placebo. Training group (This group performs the 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 So orally daily). Training+ Salvia officinalis supplementation group (In this group the Simultaneous intervention, training, and Salvia officinalis supplement will treat with the same protocol described in the previous part).
Main outcome variables
Inflammatory indexes such as Tumor Necrosis Factor-α. Interleukin-10; Interleukin-12; Fasting Glucose; Fasting Insulin and Insulin Resistance Index.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140415017288N9
Registration date: 2023-02-03, 1401/11/14
Registration timing: registered_while_recruiting

Last update: 2023-02-03, 1401/11/14
Update count: 0
Registration date
2023-02-03, 1401/11/14
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
2023-01-05, 1401/10/15
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preventive effects of Exercise Training and Salvia officinalis on Inflammation and Insulin Resistance in Postmenopausal Women
Public title
Effect of Exercise and Salvia officinalis on Postmenopausal Women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
being menopausal Age range 50-65 years Inactive lifestyle (exercise less than 1 hour per week) Not taking medicine in the last 6 months. Being willing to participate in the study.
Exclusion criteria:
Supplement use. Diagnosis of other 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
  • Participant
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 by Simple randomization by the 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. Number 1 is for the Placebo Control group (C), number 2 is for the Aerobic Training Group (AT), number 3 is for the Salvia Officinalis group (So) and 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)
Single blinded
Blinding description
All the study groups received the supplement in sealed packages that were coded. Coding is done by the researcher and the subjects do not know about it. The Salvia officinalis (So) and Training-Salvia Officinalis (ATSo) receive three 100 mg tablets of So for eight weeks. Placebo Control (C), and Aerobic Training (AT) groups receive a placebo in the same pharmacological presentation. Starch is used as a placebo.
Placebo
Used
Assignment
Parallel
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.1401.032

Health conditions studied

1

Description of health condition studied
Postmenopausal Women
ICD-10 code
Z79.890
ICD-10 code description
Postmenopausal

2

Description of health condition studied
Insulin resistance
ICD-10 code
R73.02
ICD-10 code description
Impaired glucose tolerance (oral)

Primary outcomes

1

Description
Tumor Necrosis Factor Alpha
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods (by ELISA method)

2

Description
Interleukin-10
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods (by ELISA method)

3

Description
Interleukin-12
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods (by ELISA method)

4

Description
Fasting blood glucose
Timepoint
Before and after the protocol
Method of measurement
Biochemical methods

5

Description
Fasting blood insulin
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods (by ELISA method)

6

Description
Insulin resistance index (HOMA-IR)
Timepoint
Before and after the protocol
Method of measurement
formulas

Secondary outcomes

empty

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 describes in 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
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, Kamdereh 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, Kamdereh 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, Kamdereh 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.
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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