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The effect of eight weeks aerobic training with garlic supplements on inflammatory and cardiovascular factors in postmenopausal women with high blood pressure and obesity

Protocol summary

Study aim
The aim of this study was to examine the The effect of eight weeks aerobic training with garlic supplements on inflammatory and cardiovascular factors in postmenopausal women with high blood pressure and obesity.
Design
36 women with high blood pressure and obesity selected and randomly divided into four groups (Control, Water; Control, Garlic; Control, Training; Garlic, Training). Training group’s perform Aerobic Training for for eight weeks, three sessions a week (55% to 65% of the reserved heart rate and for 30 to 55 min). Garlic and Garlic plus Training will feed 1000 mg of Garlic for eight weeks (Twice a day before breakfast and dinner).
Settings and conduct
The location of the research is Tabib Sports Complex in Sari, which has already been coordinated. In this research, people who work with subjects are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmation of blood pressure by the doctor, Lack of other underlying illnesses, Not attending a regular exercise program in the past six months, Permission to participate in the exercise program with the opinion of a specialist physician, Satisfaction to participate in the study, Have at least 50 years of age Exclusion criteria: Use supplement and practice, Diagnosis of other underlying illnesses during protocol implementation, Change in drug intake, Risk of exercise or supplementation
Intervention groups
Aerobic exercise and Garlic supplementation
Main outcome variables
Effect of aerobic training with Garlic supplements on inflammatory and cardiovascular factors such as: Lipocalin-1, IL-1β, MMP-3, MMP-9, TIMP-1

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140415017288N6
Registration date: 2019-07-22, 1398/04/31
Registration timing: prospective

Last update: 2019-07-22, 1398/04/31
Update count: 0
Registration date
2019-07-22, 1398/04/31
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
2019-08-06, 1398/05/15
Expected recruitment end date
2019-10-07, 1398/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks aerobic training with garlic supplements on inflammatory and cardiovascular factors in postmenopausal women with high blood pressure and obesity
Public title
Effect of training and Garlic on Blood Pressure
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of blood pressure by the doctor Lack of other underlying illnesses Not attending a regular exercise program in the past six months Permission to participate in the exercise program with the opinion of a specialist physician Satisfaction to participate in the study Have at least 50 years of age
Exclusion criteria:
Use supplement and practice Diagnosis of other underlying illnesses during protocol implementation Change in drug intake Risk of exercise or supplementation
Age
From 50 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 36
More than 1 sample in each individual
Number of samples in each individual: 9
in postmenopausal women with high blood pressure and obesity
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, subjects are selected Simple randomization by random allocation rule. After determining the sample size, they will be equally divided into four groups (Control, Water; Control, Garlic; Control, Training; Garlic, Training).
Blinding (investigator's opinion)
Single blinded
Blinding description
The Control- Garlic and Garlic +Training patients receive Momordica charantia, two capsules orally of 500 mg twice daily before breakfast and dinner for 8 weeks. Control-Water and Control-Training groups receive placebo in the same pharmacological presentation. Starch is used as placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sport Sciences Research Institute of Iran
Street address
Tehran: Motahari Ave., Miramad St., No. 5th Lane
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.SSRC.REC.1398.039

Health conditions studied

1

Description of health condition studied
Hypertensive diseases
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Effect of aerobic training and Garlic on Lipocalin-2
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

2

Description
Effect of aerobic training and Garlic on IL-1β
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

3

Description
Effect of aerobic training and Garlic on MMP-3
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

4

Description
Effect of aerobic training and Garlic on MMP-9
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

5

Description
Effect of aerobic training and Garlic on TIMP-1
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

Secondary outcomes

empty

Intervention groups

1

Description
Control group: : in this group we have not any intervention during 6 weeks, and will consider this group as placebo.
Category
Placebo

2

Description
Intervention group: Training group (in this group for 8 week, three session/weeks, the training start with 10 min warming and then 30 min 55% reserved heart rate, increase to the training time up 55 min until the end of intervention with 65% of the reserved heart rate).
Category
Treatment - Other

3

Description
Intervention group: Garlic group (in this group eat 1000 mg of Garlic for eight weeks Twice a day before breakfast and dinner).
Category
Treatment - Other

4

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

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center of Sari city
Full name of responsible person
Ahmad Abdi
Street address
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7216
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
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7126
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
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7126
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
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+1 143217126
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
Ayatollah Amoli Branch, Islamic Azad University
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7126
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
The report is submitted to the research department of the university. Also published as a paper.
When the data will become available and for how long
Since 2020
To whom data/document is available
All researchers
Under which criteria data/document could be used
Citing references
From where data/document is obtainable
Scientific bases and Ayatollah Amoli Branch, Islamic Azad University, amol, Iran
What processes are involved for a request to access data/document
Maximum one week
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