The effect of 8 weeks of aerobic training and the consumption alcoholic extract of nettle on selected inflammatory markers in overweight and obese women
Objective: the effect of 8 weeks of aerobic training and the consumption of alcoholic extract of nettle on TNF- α،IL-6 and plasma CRP levels in overweight and obese women study design: Randomized sealed envelope; single-blind (Participants); placebo-controlled; single-cente. Inclusion criteria: female gender; age ; no history of heart disease; arthritis; do not use other herbal medicines. Exclusion criteria: use of herbal medicines except nettle; pregnancy; breastfeeding; risk of other seroud diseases. Sample size of 48 patients in 4 groups. Outcomes: cardiovascular risk factors associated with obesity and weight loss with exercise and use of nettle extract.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022324402N2
Registration date:2016-04-14, 1395/01/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-14, 1395/01/26
Registrant information
Name
Azita Monfared
Name of organization / entity
Sistan and Baluchestan University
Country
Iran (Islamic Republic of)
Phone
+98 543425791
Email address
azita_monfared@pgs.usb.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan, University Of Sistan and Bluchestan
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-01-10, 1394/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of aerobic training and the consumption alcoholic extract of nettle on selected inflammatory markers in overweight and obese women
Public title
The effect of exercise and extract Nettle on obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female gender; age; lack of any history of cardiovascular disease, arthritis and ...; do not use other herbal medicines.
Exclusion criteria: use of herbal medicines except nettle; pregnancy; breastfeeding; risk of diseases.
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Medical Sciences of Zahedan
Street address
Zahedan Persian Gulf Boulevard, Healthcare Zahedan University of Medical Sciences
City
Zahedan
Postal code
98167-43463
Approval date
2016-02-21, 1394/12/02
Ethics committee reference number
IR.ZAUMS.REC.1394.417
Health conditions studied
1
Description of health condition studied
Obesity and Overweight
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
TNF- α
Timepoint
Before the intervention. 8 week after the intervention
Method of measurement
Bloodletting
2
Description
IL-6
Timepoint
Before the intervention. 8 week after the intervention
Method of measurement
Bloodletting
3
Description
CRP
Timepoint
Before the intervention. 8 week after the intervention
Method of measurement
Bloodletting
Secondary outcomes
1
Description
Body.Mass.Index(BMI)
Timepoint
The beginning of training, immediately after training
Method of measurement
Weight / height to the power of 2
2
Description
Blood pressure
Timepoint
The beginning of training, immediately after training
Method of measurement
Manometers
3
Description
Waist-to-hip ratio
Timepoint
The beginning of training, immediately after training
Method of measurement
Waist circumference/hip circumference
4
Description
Heart rate
Timepoint
The beginning of training, immediately after training
Method of measurement
thermometers Polar heart rate
Intervention groups
1
Description
Aerobic training+placebo; for 8 weeks, 3 times a week and placebo
Category
Placebo
2
Description
aerobic training exercises with nettle extract ;for 8 weeks, 3 days per week.wemon practice along with nettle extract once a day for a two month and consumed.
Category
Treatment - Drugs
3
Description
nettle group: not done any exercise and Only once a day for 2 months nettle 8 milliliter used.
Category
Treatment - Drugs
4
Description
control group; not done any exercise and Placebo every day for 2 months used.
and daily intake of 8 ml placebo (same color water extract) was used as a placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Sistan and Baluchestan
Full name of responsible person
Azita Monfared
Street address
Street University, University of Sistan and Bluchestan, zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Mohamad Kordi Tamandani
Street address
Zahedan, University of Sistan and Baluchestan, Research Assistant
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Sistan and Baluchestan
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan, University of Sistan and Bluchestan
Full name of responsible person
Azita Monfared
Position
Master of Science
Other areas of specialty/work
Street address
115, Naz street, University of Sistan and Baluchestan, Zahedan, Iran
City
Zahedan
Postal code
Phone
+98 54 3342 5791
Fax
Email
azitamonfared@pgs.usb.ac.r
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Sistan and Bluchestan
Full name of responsible person
Azita Monfared
Position
Master of Science
Other areas of specialty/work
Street address
Zahedan, University of Sistan and Bluchestan
City
Zahedan
Postal code
Phone
+98 54 3342 5791
Fax
Email
azitamonfared@pgs.usb.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Sistan and Bluchestan
Full name of responsible person
Azita Monfared
Position
Master of Science
Other areas of specialty/work
Street address
Zahedan, University of Sistan and Bluchestan
City
Zahedan
Postal code
Phone
+98 54 3342 5791
Fax
Email
azitamonfared@pgs.usb.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)