Protocol summary

Study aim
The effects of aerobic training and omega-3 supplementation on the levels of Paraoxonase, myeloperoxidase and some inflammatory and oxidative markers in overweight and obese women’s
Design
The study is a randomized by lottery, factorial clinical trial, double-blind. The target population includes 40 obese women in Kerman. Individuals are divided into four groups of 10, Phase 3. The intervention and control groups receive 2,000 mg of omega-3 supplement or placebo daily for 8 weeks. The aerobic training program runs for 8 weeks, 3 sessions per week, for 25 minutes and an intensity of 50 to 70% of the maximum heart rate.
Settings and conduct
.Because the placebo and omega-3 supplement are placed inside the capsule in exactly the same way, participants and researchers are not aware of the type of supplement they receive. Exercises are performed in Valiasr Sports Club in Kerman. Blood sampling is performed by the blood sampling manager of Razi Laboratory.
Participants/Inclusion and exclusion criteria
Obese women 25 to 40 years old who are physically healthy (no history of any cardiovascular disease, no history of specific disease or neuropsychiatric illness), no allergies to drugs and medications, no dietary supplements, medication or diet in the last 3 months, not doing regular exercise in the last 6 month.
Intervention groups
Subjects after filling informed consent form to participate in the research, are divided in a simple random way (based on a table of random numbers) into four groups of 10 people: 1. Placebo group 2. Omega 3 supplement group 3. Aerobic training group 4. Aerobic training group + omega 3 supplement
Main outcome variables
Paraoxonase 1, Myeloperoxidase, Apolipoprotein A1, Apolipoprotein B, C-reactive protein,Insulin resistance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200722048167N1
Registration date: 2020-08-08, 1399/05/18
Registration timing: retrospective

Last update: 2020-08-08, 1399/05/18
Update count: 0
Registration date
2020-08-08, 1399/05/18
Registrant information
Name
Shila Montazer
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3245 3916
Email address
sh.montazer@srbiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of aerobic training and omega-3 supplementation on the levels of Paraoxonase, myeloperoxidase and some inflammatory and oxidative markers in overweight and obese women’s
Public title
Effect of aerobic training and omega-3 exercise on oxidative and inflammatory elements in obese women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 25 to 40 years; Physical health; Subjects' body mass index more than 25 kg / m2 and less than 35 kg / m2; Ability to participate in aerobic exercise program; Not participating in regular exercise for the past year; No diagnosed diseases such as diabetes, cardiovascular, cancer, gastrointestinal diseases, liver, kidney, autoimmune diseases, inflammation, thyroid, polycystic ovary syndrome; Do not take antihypertensive drugs or lipid-lowering drugs; Do not take nutritional supplements for at least six months before the study.
Exclusion criteria:
No signing informed consent Smoking or drinking alcohol at least once a week Use of contraceptives and nonsteroidal anti-inflammatory drugs (NSAIDs) in the last 3 months Pregnancy and lactation
Age
From 25 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Using the lottery method, the names of the subjects on a piece of paper It is written separately and placed inside a container then the names of the subjects are removed and is placed in the intervention group or placebo. The first 30 names are placed in the intervention group and the rest in the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo and supplement Omega 3 are placed inside the similar capsules. Patients and researchers are not aware of the type of supplement received.
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 - University Scientific Unit
Street address
Tehran - End of Shahid Sattari Highway - University Square - Hesarak Martyrs Boulevard
City
Kerman
Province
Kerman
Postal code
1477893855
Approval date
2020-06-24, 1399/04/04
Ethics committee reference number
IR.IAU.SRB.REC.1399.010

Health conditions studied

1

Description of health condition studied
Overweight and obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Paraoxonase 1
Timepoint
First, the end of the study
Method of measurement
ELISA Kit

2

Description
Myeloperoxidase
Timepoint
First, the end of the study
Method of measurement
ELISA Kit

3

Description
Apolipoprotein A1
Timepoint
First, the end of the study
Method of measurement
ELISA Kit

4

Description
Apolipoprotein B
Timepoint
First, the end of the study
Method of measurement
ELISA Kit

5

Description
C-Reactive Protein
Timepoint
First, the end of the study
Method of measurement
Bionic Kit

Secondary outcomes

1

Description
Blood Suger
Timepoint
First, the end of the study
Method of measurement
Glucose Test Kit

2

Description
Insulin
Timepoint
First, the end of the study
Method of measurement
Insulin ELISA Kit

3

Description
VO2 max
Timepoint
First, the end of the study
Method of measurement
Rockport test and formula method

4

Description
Body Mass Index
Timepoint
First, the end of the study
Method of measurement
Twice the height / weight

Intervention groups

1

Description
Intervention group: Omega 3 supplement group (taking omega 3 supplement, not participating in aerobic exercise program):for 8 weeks and daily 2000 mg of omega 3 fatty acid supplement in the form of two 1000 mg capsules containing 360 mg of Eicosa pentanoic acid and 240 mg of Docosa hexaenoic acid (morning and night) made by Karen)and do the activities of daily living
Category
Prevention

2

Description
Intervention group: Aerobic training group (participation in aerobic training program- not taking omega3 supplements):The training program including 8 weeks of aerobic training(Running or fast walking) every week 3 sessions. Intensity of training in the first two weeks 50 to 55%, in the second two weeks 55 to 60%, in the third two weeks 60 to 65% and in the fourth two weeks 65 to 70% maximum heart rate is designed and the duration of each exercise session is about 25 It is minutes. Before and after each exercise session, 10 minutes of warm-up and eight minutes of cooling are performed, respectively.During this week, take placebo capsules morning and night. (Similar to omega-3 capsules but containing oral paraffin).Made by Darogster Company
Category
Prevention

3

Description
Intervention group: Aerobic training group + omega 3 supplement (taking omega 3 supplement and simultaneously participating in aerobic training program ): for 8 weeks and daily 2000 mg of omega 3 fatty acid supplement in the form of two 1000 mg capsules containing 360 mg of Eicosa pentanoic acid and 240 mg of Docosa hexaenoic acid (morning and night) made by Karen) in addition to the training program including 8 weeks of aerobic training (Running or fast walking)every week 3 sessions. Intensity of training in the first two weeks 50 to 55%, in the second two weeks 55 to 60%, in the third two weeks 60 to 65% and in the fourth two weeks 65 to 70% maximum heart rate is designed and the duration of each exercise session is about 25 It is minutes. Before and after each exercise session, 10 minutes of warm-up and eight minutes of cooling are performed, respectively.
Category
Prevention

4

Description
Control group: Placebo group (not participating in aerobic exercise program, not taking omega 3 supplements) During these 8 weeks, take placebo capsules morning and night. (Similar to omega-3 capsules but containing oral paraffin) Made by Darogster Company,In addition to daily life activities.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman University of Medical Sciences
Full name of responsible person
Shila montazer
Street address
Campus of Kerman University of Medical Sciences, at the beginning of Haft Bagh axis
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
shilamontazer@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mandana Gholami
Street address
Shohada Hesarak Boulevard , University Square, End of Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 9827
Email
m.gholami@srbiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Faculty of Literature, Tehran University of Research Sciences
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shila Montazer
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
North Alley 2 West 2، Elahieh Street،Nasr Boulevard
City
Kerman
Province
Kerman
Postal code
7618698181
Phone
+98 34 3245 3916
Email
shilamontazer@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Ali Azarbayjani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Shohada of Hesarak Boulevard,University Square,Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 9827
Email
M_Azarbayjani@iauctb.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shila Montazer
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
North Alley 2 West 2، Elahieh Street، Nasr Boulevard
City
Kerman
Province
Kerman
Postal code
7618698181
Phone
+98 34 3245 3916
Email
shilamontazer@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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