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Anti Inflammatory Properties of Combined Aquatic Extract of Ferulago Angulata Boiss with Aerobic Exercise on Pro Inflammatory Indices in Obese Males

Protocol summary

Study aim
The effects of aerobic exercise along with water extract of Ferulagoangulata consumption on serum levels of IL-6, IL-18, IL-1β and TNF-α in obese men
Design
Factorial group, Not blinded, randomised controlled trial, The study sample included 40 young obese men (30-40 years, Body Mass Index>30).
Settings and conduct
This research will be conducted at Abadan University of Medical Sciences. In this study, 40 young obese men (BMI > 30, 30-40 years old) will be selected randomly and randomly divided into four equal groups (n = 10), training, training-supplementation, supplementation and control. Participants in supplementary groups received 50 mg/ml Ferulago Angulata extracts daily for 12 weeks. Aerobic training program included 12 weeks of training, 3 sessions per week and each session was 20 minutes at 60-70% of Vo2max. Blood samples were taken from subjects 48 hours before and after the intervention in fasting state.
Participants/Inclusion and exclusion criteria
inclusion criteria: Male gender, BMI higher than 30, BMI higher than 30 Exclusion criteria: Having a history of a specific illness,Taking cigarettes and drugs, Taking medicine and supplement
Intervention groups
Training group:The aerobic training consisted of running on a treadmill at 60-70% of Vo2max. Supplementation group: According to the literature, the daily supplementation dose for each participant was 50 mg/ml. Training-supplementation group: Exercise and supplements simultaneously Control group: Participants in the control group did not take part in any exercise activities during this period
Main outcome variables
Interleukin 6؛ Interleukin18؛ Interleukin1β؛ TNF-α

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160129026251N4
Registration date: 2019-02-02, 1397/11/13
Registration timing: retrospective

Last update: 2019-02-02, 1397/11/13
Update count: 0
Registration date
2019-02-02, 1397/11/13
Registrant information
Name
Iman Zakavi
Name of organization / entity
Abadan Medical Sciences School
Country
Iran (Islamic Republic of)
Phone
+98 916 814 3051
Email address
zakavi.i@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Anti Inflammatory Properties of Combined Aquatic Extract of Ferulago Angulata Boiss with Aerobic Exercise on Pro Inflammatory Indices in Obese Males
Public title
Effect of Exercise and Supplementation on Pro Inflammatory Cytokines
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male gender BMI higher than 30 Men aged 30 to 40 years
Exclusion criteria:
Having a history of a specific illness Taking cigarettes and drugs Taking medicine and supplement
Age
From 30 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Following the screening process, 40 obese Men will be selected randomly and randomly divided into 4 groups.Subjects are randomly selected to have a BMI greater than 30. Randomization tools include random digits table and spss software version 24.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Abadan University of Medical Sciences
Street address
Ethics committee of Abadan University of Medical Sciences, Vice chancellor for research, Opposite International Airport Jami Abadan, Flying field, Abadan City, Khouzestan.
City
Abadan
Province
Khouzestan
Postal code
6395116214
Approval date
2015-05-20, 1394/02/30
Ethics committee reference number
IR.ABADANUMS.REC.1394.10

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Interleukin 6
Timepoint
Before intervention, 3 months after intervention
Method of measurement
pg/ml- ELISA method

2

Description
Interleukin18
Timepoint
Before intervention, 3 months after intervention
Method of measurement
pg/ml- ELISA method

3

Description
Interleukin1β
Timepoint
Before intervention, 3 months after intervention
Method of measurement
pg/ml- ELISA method

4

Description
TNF-α
Timepoint
Before intervention, 3 months after intervention
Method of measurement
pg/ml- ELISA method

Secondary outcomes

1

Description
Weight
Timepoint
Before intervention, 3 months after intervention
Method of measurement
kg, In body Device

2

Description
Body Mass Index
Timepoint
Before intervention, 3 months after intervention
Method of measurement
kg/m2-In Body device

3

Description
fat percentage
Timepoint
Before intervention, 3 months after intervention
Method of measurement
% Percentage, In Body Device

4

Description
Waist -to-Hip Ratio
Timepoint
Before intervention, 3 months after intervention
Method of measurement
cm, Meter

5

Description
Maximal Oxygen Consumption
Timepoint
Before intervention, 3 months after intervention
Method of measurement
ml/kg/min---By Rockport 1-mile walk test

Intervention groups

1

Description
Intervention group 1:The aerobic training consisted of running on a treadmill at 60-70% of Vo2max. Each training session included a 5-10 minutes of warm-up and cool down. After four weeks, maximal HR was measured once more and the training intensity of 60-70% of Vo2max was adjusted accordingly
Category
Other

2

Description
Intervention group 2:Leaves form Ferulagoangulata were grounded using an electric mill and the powder was then bolted to separate the big particles. To make the Ferulagoangulata extract 8 grams of the powder was wrapped in a piece of two-layer tiffany cloth and then was put in a flask containing 100 mm of distilled, sterilized water. The container was then put in a shaker for 24 hours at room temperature. The extract was then passed through a filter under the laboratory’s hood. The produced extract was then stored at 4ºc before consumption. According to the literature, the daily supplementation dose for each participant was 50 mg/ml.Participants in the supplementation group did not take part in any exercise activities during this period and were only involved in their daily routine activities
Category
Other

3

Description
Intervention group 3:The aerobic training consisted of running on a treadmill at 60-70% of Vo2max. Each training session included a 5-10 minutes of warm-up and cool down. After four weeks, maximal HR was measured once more and the training intensity of 60-70% of Vo2max was adjusted accordingly. Leaves form Ferulagoangulata were grounded using an electric mill and the powder was then bolted to separate the big particles. To make the Ferulagoangulata extract 8 grams of the powder was wrapped in a piece of two-layer tiffany cloth and then was put in a flask containing 100 mm of distilled, sterilized water. The container was then put in a shaker for 24 hours at room temperature. The extract was then passed through a filter under the laboratory’s hood. The produced extract was then stored at 4ºc before consumption. According to the literature, the daily supplementation dose for each participant was 50 mg/ml. In this group exercise and supplements will be done simultaneously.
Category
Other

4

Description
Control group: Participants in the control group did not take part in any exercise activities during this period and were only involved in their daily routine activities
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Tabatabai Hospital
Full name of responsible person
Amin Delavari
Street address
Shahid Tabatabai HospitaL, Ghale Kamisi St., Baghmalek City, Kouzestan
City
Baghmalek
Province
Khouzestan
Postal code
6395116213
Phone
+98 61 4372 6750
Email
amindelavari@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
DR mohamad mahboobi
Street address
Vice chancellor for research, Abadan University of Medical Sciences, Opposite International Airport Jami Abadan, Flying field, Abadan city, Khouzestan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 5364
Email
research.abadan@chmail.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadan University of Medical Sciences
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
Abadan University of Medical Sciences
Full name of responsible person
Iman Zakavi
Position
Ph.D. Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Abadan University of Medical Sciences, Opposite international airport Jami Abadan, Flying field, Abadan city, Khouzestan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 5364
Email
imanzakavi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Dr Iman Zakavi
Position
P.H.D
Latest degree
Specialist
Other areas of specialty/work
Physiology
Street address
Vice chancellor for research, Abadan University of Medical Sciences, Opposite International Airport jami abadan, Flying field, Abadan city, Kouzestan, Iran
City
Abadan
Province
Khouzestan
Postal code
6395116214
Phone
+98 61 5326 5364
Email
imanzakavi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Iman Zakavi
Position
P.H.D
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Abadan University of Medical Sciences, Opposite International Airport Jami Abadan, Flying field, Abadan City, Khouzestan.
City
Abadan
Province
Khouzestan
Postal code
6395116214
Phone
+98 61 5326 5361
Email
imanzakavi@yahoo.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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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