Evaluation the effect of eight week aerobic training and Omega 3 ingestion on the levels of Adipsin and insulin resistance in overweight and obese women
The effect of eight week aerobic training and Omega 3 ingestion on the levels of Adipsin and insulin resistance in overweight and obese women
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, on 40 patients
Settings and conduct
Study place: Faculty of Humanities, Islamic Azad University, Science and Research Branch. Type of blinding: double blind. How to blind: Before sampling, the packages containing supplements and placebos were numbered and then the package that matched each person's number according to the list was given to them
Participants/Inclusion and exclusion criteria
Inclusion criteria: women between the ages of 25 and 40 years old; Not participating in regular exercise at least during last year.
Non-inclusion criteria: cardiovascular disease, type 2 diabetes, hypertension, malignant diseases such as various types of cancer, taking nutritional supplements for at least six months before the study
Intervention groups
Control group: placebo, Intervention group 1 : Omega 3, Intervention group 2 : aerobic exercise, Intervention group 3 : aerobic exercise + omega 3.
Main outcome variables
Adipsin levels; Insulin resistance; Weight
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200811048360N1
Registration date:2020-12-16, 1399/09/26
Registration timing:retrospective
Last update:2020-12-16, 1399/09/26
Update count:0
Registration date
2020-12-16, 1399/09/26
Registrant information
Name
Saleheh Ahmadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4601 6861
Email address
s_ahmadzadeh6612@yahoo.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
Evaluation the effect of eight week aerobic training and Omega 3 ingestion on the levels of Adipsin and insulin resistance in overweight and obese women
Public title
The effect of aerobic training and Omega 3 ingestion on the levels of Adipsin and insulin resistance
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
overweight and obese
Women in the age range of 25 to 40 years
Not participating in regular exercise at least last year
Exclusion criteria:
Simultaneous participation in other sports training programs
Cardiovascular disease
Type 2 diabetes
High blood pressure
Malignant diseases such as cancer
Take nutritional supplements at least six months before the study
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
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, 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. Orientation sessions are held separately for the two groups receiving aerobic exercise. All participants are asked not to exercise outside the program during the research period
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Azad University, Science and Research Branch
Street address
Azad University Science and Research Branch, Daneshgah boulevard, Daneshgah square, Simon Bulivar boulevard
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2020-11-18, 1399/08/28
Ethics committee reference number
IR.IAU.SRB.REC.1399.088
Health conditions studied
1
Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
levels of Adipsin
Timepoint
Before the intervention, after the intervention
Method of measurement
Measurement of serum levels in participants' blood samples
2
Description
Insulin resistance
Timepoint
Before the intervention, after the intervention
Method of measurement
Measurement of serum levels in participants' blood samples
3
Description
Weight
Timepoint
Before the intervention, after the intervention
Method of measurement
seca scale
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 (oral paraffin), 2000 mg daily, in the form of two 1000 mg capsules in the morning and evening (with or after breakfast and dinner).
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
Farzad Movahedi Sobhani
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-movahedi@srbiau.ac.ir
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
Saleheh Ahmadzadeh
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, Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
s_ahmadzadeh6612@yahoo.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
Saleheh Ahmadzadeh
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
s_ahmadzadeh6612@yahoo.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
After the required time, the file containing patient information and research results will be provided only for research purposes to the research institutes or researchers who wish to research in this field
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 review and use in other research projects