Protocol summary

Summary
The objective of this study was to assess the effects of combined selective short aerobic moderate intensity exercise and soya intake on blood lipids and obesity of inactive obese postmenopausal women. Fifty six inactive obese postmenopausal women with BMI greater than 30 kg/m2 were recruited from women of uremia and were randomly in four groups: participating in training with soy consumption ,participating in training, soy consumption and control group. Exercise training were performed for 10 weeks and 3 sessions per week with 60 minutes and the range of 60-70% maximum heart rate . The subjects of soya and training -soya group intake 100 gram soya nut daily for 10 weeks. body mass index, body fat percent & waist to hip ratio were Measured at baseline and 10 weeks after exercise and soya intake. at baseline and 10 weeks after exercise and soya intake for biochemical measurements, after 12 to 14 hours overnight fasting, blood samples were taken for biochemical analysis, including cholesterol, triglycerides, LDL-C & HDL-C of fasting plasma samples.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112258518N1
Registration date: 2012-02-12, 1390/11/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-02-12, 1390/11/23
Registrant information
Name
Azam Zarneshan
Name of organization / entity
Azarbaijan University of Tarbiat Moallem
Country
Iran (Islamic Republic of)
Phone
+98 41 2432 7505
Email address
zarneshan@azarunive.edu
Recruitment status
Recruitment complete
Funding source
Azarbaijan University of Tarbiat Moallem
Expected recruitment start date
2010-12-28, 1389/10/07
Expected recruitment end date
2011-06-02, 1390/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of combined selective aerobic moderate intensity exercises and soya intake on decrease of blood lipids and obesity at inactive obese postmenopausal women
Public title
Effects of exercise and soya intake on decrease of blood lipids and obesity at inactive obese postmenopausal women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: postmenopausal; obesity; inactive Exclusion criteria: having Thyroid, Kidney, cardiovascular and diabetes diseases; intake spesial drug and supplementation; irregular presence in training; irregular soy consumptio.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Imam Khomeini Street, Tabriz,IRAN
City
Tabriz
Postal code
5166616471
Approval date
2012-01-16, 1390/10/26
Ethics committee reference number
9071

Health conditions studied

1

Description of health condition studied
N/A
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
blood lipids
Timepoint
Pre and post 10 week protocol
Method of measurement
biochemical measurements on blood sample

Secondary outcomes

1

Description
obesity
Timepoint
Pre and post 10 week protocol
Method of measurement
Body Composition Monitor Device

Intervention groups

1

Description
Exercise training with soy consumption in Exercise-soya group. Aerobic exercise training that Includes of aerobic exercises, jogging, running with moderate intensity, sit and reach and flexibility were performed for 10 weeks and 3 sessions per week with 60 minutes and the range of 60-70% maximum heart rate. The subjects intake 100 gram soya nut daily for 10 weeks.
Category
Lifestyle

2

Description
Exercise training in Exercise group. Aerobic exercise training that Includes of aerobic exercises, jogging, running with moderate intensity, sit and reach and flexibility were performed for 10 weeks and 3 sessions per week with 60 minutes and the range of 60-70% maximum heart rate
Category
Lifestyle

3

Description
soya intake in soya group was 100 gram soya nut daily for 10 weeks.
Category
Lifestyle

4

Description
no participate and no soy intake in control group for 10 weeks.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Azerbaijani University of Tarbiat Moallem
Full name of responsible person
Azam Zarneshan
Street address
Azarbaijan University of Tarbiat Moallem, 35 km Road Tabriz-Maragheh, Tabriz, East Azarbaijan Provin
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Azarbaijan University of Tarbiat Moallem
Full name of responsible person
Azam zarneshan
Street address
Azarbaijan University of Tarbiat Moallem, 35 km Road Tabriz-Maragheh, Tabriz, East Azarbaijan Provin
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azarbaijan University of Tarbiat Moallem
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
Azerbaijani University of Tarbiat Moallem
Full name of responsible person
Azam Zarneshan
Position
Master's degree in sports physiolog/faculty member
Other areas of specialty/work
Street address
Azarbaijan University of Tarbiat Moallem, 35 km Road Tabriz-Maragheh, Tabriz, East Azarbaijan Province, Iran
City
Tabriz
Postal code
5375171379
Phone
+98 41 2432 7505
Fax
+98 41 2432 7522
Email
zarneshan@azaruniv.edu
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Azerbaijan University of Tarbiat Moallem
Full name of responsible person
Azam Zarneshan
Position
Master of Exercise Physiology
Other areas of specialty/work
Street address
Azarbaijan University of Tarbiat Moallem, 35 km Road Tabriz-Maragheh, Tabriz, East Azarbaijan Provin
City
Tabriz
Postal code
5375171379
Phone
+98 41 2432 7505
Fax
+98 41 2432 7522
Email
zarneshan@azaruniv.edu
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Azarbaijan University of Tarbiat Moallem
Full name of responsible person
Azam Zarneshan
Position
Master of Exercise Physiology/faculty member
Other areas of specialty/work
Street address
Azarbaijan University of Tarbiat Moallem, 35 km Road Tabriz-Maragheh, Tabriz, East Azarbaijan Province, Iran
City
Tabrize
Postal code
5375171379
Phone
+98 41 2432 7505
Fax
+98 41 2432 7522
Email
zarneshan@azaruniv.edu
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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