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The effect of eight weeks aerobic training and omega3 ingestion on the levels of IL-1β and MCP-1 in overweight and obese women

Protocol summary

Study aim
Explaining the effect of eight weeks of aerobic exercise and omega-3 intake on IL-1β and MCP-1 levels in overweight and obese women
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, on 40 patients
Settings and conduct
Pre-test blood samples will be collected prior to the 8-week training intervention. In the next stage, the subjects of the aerobic exercise group and aerobic exercise + omega 3 will participate in the desired exercise program for 8 weeks. Each aerobic exercise session will consist of 47 minutes of brisk walking or jogging with an intensity equivalent to 70-60% of the maximum heart rate, which is performed three times a week.Before and after each aerobic exercise session, warm-up and cooling will be performed, respectively. Consumption of omega-3 will be considered 2000 mg per day.48 hours after the last exercise session and in order to eliminate the acute effects of the last session of aerobic exercise and omega 3 consumption, the subjects will be present again in the post-test phase for blood sampling. 7 ml of blood will be taken from each subject while sitting and from a brachial vein. The blood samples are then centrifuged.
Participants/Inclusion and exclusion criteria
Overweight and obese women between the ages of 25 and 40, not participating in regular exercise for the past year, not having type 2 diabetes, not having other chronic diseases such as cancer, not having a history of heart disease, and lack of physical and medical restrictions to participate in exercise
Intervention groups
Subjects will be randomly divided into 4 groups including placebo, omega 3, aerobic exercise and aerobic exercise + omega 3
Main outcome variables
Study level of IL-1β and MCP-1 in overweight and obese women, weight loss, Study the risk of inflammatory diseases

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200806048320N1
Registration date: 2020-11-22, 1399/09/02
Registration timing: retrospective

Last update: 2020-11-22, 1399/09/02
Update count: 0
Registration date
2020-11-22, 1399/09/02
Registrant information
Name
Seyyedeh Fatemeh Abdollah Pouri Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2209 1547
Email address
f.p.hosseini@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-15, 1399/05/25
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks aerobic training and omega3 ingestion on the levels of IL-1β and MCP-1 in overweight and obese women
Public title
The effect of eight weeks aerobic training and omega3 ingestion on the levels of IL-1β and MCP-1 in overweight and obese women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
overweight and obese Age range 25-40 years
Exclusion criteria:
Subjects did not participate in regular exercise during the past year No type 2 diabetes No other chronic diseases such as cancer No history of cardiovascular disease No physical or medical restrictions for participating in sports exercises
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is performed. Once the participants were identified, their names were randomly written into a list, identifying each person with a number. Then, using the random number table method, we randomly selected a number by moving the mouse. From that number to the tenth number were located in the placebo group, the eleventh to the twentieth in the supplement group, the twenty-first to the thirtieth in the aerobic exercise group and the remaining ten people in the supplement and aerobic exercise group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are blind to being in the intervention or control group.The researcher is also blind to the participants being in the supplement or placebo group
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 Science and Research Branch
Street address
Science and Research Branch, Daneshgah Blvd, Daneshgah Sq., Simon Bulivar Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2020-11-18, 1399/08/28
Ethics committee reference number
IR.IAU.SRB.REC.1399.089

Health conditions studied

1

Description of health condition studied
Overweight
ICD-10 code
E66.3
ICD-10 code description
Overweight

2

Description of health condition studied
Obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Serum IL-1B and MCP-1 levels
Timepoint
Before the intervention, after the intervention
Method of measurement
Measurement of serum levels in participants' blood samples

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: Aerobic Exercise For eight weeks and three sessions per week, Exercise intensity is 50-55% in the first two weeks, 55-60% in the second two weeks, 60-65% in the third two weeks, and 65-70% in the fourth two weeks. The duration of each exercise session is about 25 minutes. 10 minutes of warm-up and eight minutes of cooling are performed before and after each exercise session, respectively.
Category
Prevention

2

Description
2nd intervention group: omega-3 supplement, 2000 mg daily, taken in two capsules of 1000 mg in the morning and evening (with or after breakfast and dinner). Omega 3 purchased from Karen Company.
Category
Prevention

3

Description
3rd intervention group: Aerobic exercise and omega 3 supplement. Aerobic Exercise For eight weeks and three sessions per week, Exercise intensity is 50-55% in the first two weeks, 55-60% in the second two weeks, 60-65% in the third two weeks, and 65-70% in the fourth two weeks. The duration of each exercise session is about 25 minutes. 10 minutes of warm-up and eight minutes of cooling are performed before and after each exercise session, respectively. And 2000 mg daily omega 3 supplement, taken in two capsules of 1000 mg in the morning and evening (with or after breakfast and dinner). Omega 3 purchased from Karen Company.
Category
Prevention

4

Description
Control group: placebo, 2000 mg daily, in the form of two 1000 mg capsules in the morning and evening (with or after breakfast and dinner) oral paraffin.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University Science and Research Branch
Full name of responsible person
Mandana GHolami
Street address
Science and Research Branch, Daneshgah Blvd, Daneshgah Sq., Simon Bulivar Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
gholami_man@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mandana Gholami
Street address
Science and Research Branch, Daneshgah Blvd, Daneshgah Sq., Simon Bulivar Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
gholami_man@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
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

2

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mandana Gholami
Street address
Science and Research Branch, Daneshgah Blvd, Daneshgah Sq., Simon Bulivar Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
gholami_man@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
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
Islamic Azad University
Full name of responsible person
Seyyede Fatemeh Abdollah Pouri Hosseini
Position
M. S. student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Science and Research Branch, Daneshgah Blvd, Daneshgah Sq., Simon Bulivar Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
f.p.hosseini@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mandana Gholami
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Science and Research Branch, Daneshgah Blvd, Daneshgah Sq., Simon Bulivar Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
gholami_man@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyyedeh Fatemeh Abdollah Pouri Hosseini
Position
M. S. student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Science and Research Branch, Daneshgah Blvd, Daneshgah Sq., Simon Bulivar Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
f.p.hosseini@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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The effect of eight weeks aerobic training and omega3 ingestion on the levels of IL-1β and MCP-1 in overweight and obese women
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in scientific and academic institutions
Under which criteria data/document could be used
It can be used for other research projects
From where data/document is obtainable
Fatemeh Abdollah Pouri Hoseini E-mail address: f.p.hosseini@gmail.com
What processes are involved for a request to access data/document
Send a summary of the research project The relationship between the research project and the research should be announced
Comments
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