The effect of eight weeks of aerobic training with orange juice in body composition and lipid profiles and antioxidant capacity and inflammatory factors in overweight middle – aged women
The aim of this study was to evaluate the effect of eight weeks of aerobic exercise with orange juice on body composition and lipid profiles and antioxidant capacity and inflammatory factors of overweight middle-aged women.
Design
Clinical trial, with control group, randomized, on 60 people
Settings and conduct
The statistical population of this study is overweight middle-aged women aged 30 to 59 years who participated in aerobic exercise sessions with orange juice supplementation, which were purposefully selected as a statistical sample after fully explaining the purpose and research method and obtaining consent. The duration of aerobic exercise was 8 weeks (3 days per week). Samples were selected from those who referred to the Kan Health Center, which is located in the training sessions of the Shahid Shaban Ali Sports Complex in the Kan region.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with a BMI above 28 who were in perfect physical and mental health.
Intervention groups
The number of samples in this study is 60 overweight women with a body mass above 28. Which were selected voluntarily and randomly divided into 4 control groups (n = 15), orange juice supplement (n = 15), exercise group (n = 15) and exercise group + orange juice supplement (n = 15).
Main outcome variables
hsCRP؛ MDA؛ body composision؛ lipid profile؛ TAC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210103049934N1
Registration date:2021-01-05, 1399/10/16
Registration timing:retrospective
Last update:2021-01-05, 1399/10/16
Update count:0
Registration date
2021-01-05, 1399/10/16
Registrant information
Name
samira ghalishourani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4460 6448
Email address
samira8810@yahoo.co.uk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
2018-07-11, 1397/04/20
Actual recruitment end date
2018-10-17, 1397/07/25
Trial completion date
2018-10-17, 1397/07/25
Scientific title
The effect of eight weeks of aerobic training with orange juice in body composition and lipid profiles and antioxidant capacity and inflammatory factors in overweight middle – aged women
Public title
The effect of eight weeks of aerobic training with orange juice in body composition and lipid profiles and antioxidant capacity and inflammatory factors in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women had a body mass index above 28 who had a general level of physical and mental health.
Exclusion criteria:
Age
From 30 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Sport Sciences Research Institute
Street address
NO3, 5th st, miremad st, motahari ave
City
tehran
Province
Tehran
Postal code
1587958711
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.SSRI.REC.1397.183
Health conditions studied
1
Description of health condition studied
Overweight middle-aged women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Inflammatory factors and overweight in middle-aged women
Timepoint
Before and after 8 weeks of aerobic exercise
Method of measurement
Pars Company test kit
Secondary outcomes
1
Description
lipid profile
Timepoint
Before and after 8 weeks of aerobic exercise
Method of measurement
Pars Company test kit
2
Description
body composision
Timepoint
Before and after 8 weeks of aerobic exercise
Method of measurement
Pars Company test kit
Intervention groups
1
Description
Interventions group: Orange Juice Supplement / Aerobic Exercise / Aerobic Exercise + Orange Juice Supplement
Category
Treatment - Other
2
Description
Control group: control
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kan Health Center
Full name of responsible person
samira sadat ghalishourani
Street address
Shahran - Koohsar St. - facing the first Shahran St. - Shahid Adhami St.
City
tehran
Province
Tehran
Postal code
1469696334
Phone
+98 21 4460 6448
Email
samira8810@yahoo.co.uk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
hossein abed natanzi
Street address
End of Shahid Sattari Highway - University Square - Shohada Hesarak Boulevard - Islamic Azad University, Science and Research Branch
City
tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 9442
Email
h-abednatanzy@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
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
samira sadat ghalishourani
Position
nutritionist in health care
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Punak Square, Hamila Blvd., Ostad Nazari Sharghi St., Golha Complex, No. 13, Unit One
City
tehran
Province
Tehran
Postal code
1469696334
Phone
+98 21 4460 6448
Email
samira8810@yahoo.uk.co
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
samira sadat ghalishourani
Position
nutritionist in health care
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Punak Square, Hamila Blvd., Ostad Nazari Sharghi St., Golha Complex, No. 13, Unit One
City
tehran
Province
Tehran
Postal code
1469696334
Phone
+98 21 4460 6448
Email
samira8810@yahoo.uk.co
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
samira sadat ghalishourani
Position
nutritionist in health care
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Punak Square, Hamila Blvd., Ostad Nazari Sharghi St., Golha Complex, No. 13, Unit One
City
tehran
Province
Tehran
Postal code
1469696334
Phone
+98 21 4460 6448
Email
samira8810@yahoo.uk.co
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only the main consequences of the study can be shared.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
It will be available to everyone.
Under which criteria data/document could be used
It will be available to everyone.
From where data/document is obtainable
To published articles
What processes are involved for a request to access data/document
One year after the full publication of the results