Effect of 8 weeks of High Intensity Interval Training with supplemental Ellagic acid on serum levels of some oxidative and antioxidant factors in obese women.
The Effect of 8 Weeks of Intense Interval Training and Oalic Acid Supplementation on Oxidative and Antioxidant Factors in Obese Women
Design
A controlled clinical trial with a randomized
Settings and conduct
Islamic Azad University Research Sciences Branch was conducted in 4 groups of 8 people (HIIT group, LA group, HIIT + LA group and control group) by 32 obese women between 30 and 30 45 years with BMI greater than 30 kg / m 2 were performed. At first, the conditions and the manner of performing the interventions were explained, then the informed consent form was filled out by the subjects. Height, weight, age and health status of the subjects were obtained before intervention. Blood samples were also taken before the intervention and 12 hours fasting. The main protocol of intense intermittent exercise was 4-minute 4-minute interval running in 95-95% HRpeak with 3 minutes walking in 50-60% HRpeak and 7 minutes. Rest is accompanied, they did. This protocol was derived from the study of Zhang et al. (2015).
In this study Placebo (cerlac) or oleic acid (98%) was administered once daily for 8 weeks at 50 mg (one capsule). 48 hours after the end of blood transfusions, serum levels of GPx, MDA and TAC were measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Lowest weight change in the last 6 months, no disease, BMI greater than 30 and no exclusion criteria: Pregnancy and breastfeeding during study, antioxidant and fat burning supplements and medications
Intervention groups
High Intensity interval training (HIIT), Ellagic Acid supplementasion (LA), HIIT+ LA
Main outcome variables
Serum Glutathione Peroxidase (GPx), Malondialdehyde (MDA) and Total Oxidative Capacity (TAC) Serum Levels as Dependent Variables and Intense Periodic Exercise and Supplementation of Oalic Acid as Dependent Variables
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191020045170N1
Registration date:2019-12-16, 1398/09/25
Registration timing:retrospective
Last update:2019-12-16, 1398/09/25
Update count:0
Registration date
2019-12-16, 1398/09/25
Registrant information
Name
Marjan Mansouri dara
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4425 4085
Email address
ledig72@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
2019-03-11, 1397/12/20
Actual recruitment end date
2019-03-18, 1397/12/27
Trial completion date
2019-07-09, 1398/04/18
Scientific title
Effect of 8 weeks of High Intensity Interval Training with supplemental Ellagic acid on serum levels of some oxidative and antioxidant factors in obese women.
Public title
The effect of exercise and supplementation of ellagic acid on obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having weight changes of less than 2kg in the last 6 months
Body mass index (BMI) greater than 30 kg / m 2
No history of any bone, cardiovascular, respiratory, liver, kidney, brain or hormonal disease
Women in districts 1-6 of Tehran
Age range between 30 and 45 years
Exclusion criteria:
Alcohol and cigarette consumption a week before the protocol
Pre-protocol skeletal injuries
Sensitivity to supplement or placebo
Having a medical prohibition letter about exercise or supplementation
Pregnancy or lactation
Age
From 30 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomized, individual, sealed envelops
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sport Sciences Research Institute of Iran
Street address
Tehran Province, Tehran, District 7, 5th Dead End
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.SSRC.REC.1398.005
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
serum levels of GPx
Timepoint
Before intervention and 48 hours after intervention (Exercise and supplementation)
Method of measurement
Colorimetric GPX assay kit, abcam 102530, Germany
2
Description
Malondialdehyde (MDA)
Timepoint
Before intervention and 48 hours after intervention (Exercise and supplementation)
Method of measurement
Colorimetric MDA assay Kit, abcam 118970, Germany
3
Description
Total antioxidant capacity serum level
Timepoint
Before intervention and 48 hours after intervention (Exercise and supplementation)
Method of measurement
Using FRAP method and 592 nm wavelength spectrophotometer using ELISA (Mercodia, Sweden)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: High Intensity Interval Training (8 weeks / three days a week) and 4-minute interval runs in 95-85% HRpeak followed by 3 minutes walking in 50-60% HRpeak and 7 minutes rest.
Category
Other
2
Description
Intervention group: Ellagic Acid Supplementation: Dosage is based on previous sources of 50 mg (one capsule / once daily for 8 weeks). This is a supplement made by the US supplement spot company.
Category
Other
3
Description
Intervention group: HIIT+LA: combined two intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Science Research
Full name of responsible person
Marjan Mansoori Dara
Street address
Islamic Azad University of Science Research
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5179
Email
ledig72@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Ghazalian
Street address
Faculty of Physical Education and Sport Sciences Islamic Azad University Research Sciences Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5179
Email
ledig72@gmail.com
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
80
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
Islamic Azad University
Full name of responsible person
Marjan Mansoori Dara
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Physical Education and Sport Sciences Islamic Azad University Research Sciences Branch
City
Tehran
Province
Tehran
Postal code
۱۴۵۱۵/۷۷۵
Phone
+98 21 4486 5179
Email
ledig72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marjan Mansoori Dara
Position
MA student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Physical Education and Sport Sciences Islamic Azad University Research Sciences Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5179
Email
ledig72@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marjan Mansoori Dara
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Physical Education and Sport Sciences Islamic Azad University Research Sciences Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5179
Email
ledig72@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