Protocol summary

Study aim
The aim was to determine the effects of eight weeks of intense interval training on the whole body, combined with the consumption of mango leaf extract, and its impact on oxidative stress indicators in overweight and obese men who have not exercised.
Design
The participants were invited to this study through announcements at the level of parks, clubs, universities, and health centers and also through awareness of the virtual space of Borujerd city. Among the 72 volunteers who declared their readiness, a written consent form was obtained, and 40 people were selected as the research sample from those who met the conditions, and they were divided into 4 groups of 10 people simply:
Settings and conduct
500 mg of dry mango extract was placed in each capsule and the subjects were asked to consume each capsule (placebo or extract) daily after meals for 56 days. WB-HIIT exercises for 8 weeks, 3 times a week, The exercises were done in the Basij sports hall in Borujerd city.
Participants/Inclusion and exclusion criteria
Body mass index more than 25 kg/m2, not suffering from cardiovascular, skeletal-muscular, or metabolic diseases, not having diabetes,
Intervention groups
1: intense interval training + placebo 2: intense interval training + water extract of mango leaves 3: consumption of aqueous extract of mango leaves 4: control (did not have any intervention)
Main outcome variables
We intend to improve the nrf2 factor and oxidative stress in overweight and obesity through exercise and herbal supplements.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141228020465N6
Registration date: 2024-07-08, 1403/04/18
Registration timing: prospective

Last update: 2024-07-08, 1403/04/18
Update count: 0
Registration date
2024-07-08, 1403/04/18
Registrant information
Name
Fatemeh Omidali
Name of organization / entity
University of Ayatollah Boroujerdi
Country
Iran (Islamic Republic of)
Phone
+98 66 4246 8320
Email address
f.omidali@abru.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-20, 1403/04/30
Expected recruitment end date
2024-07-31, 1403/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of Whole-Body High-Intensity Interval Training with the consumption of mango leaf extract on the serum levels of NRF2 and antioxidant stress in overweight and obese men
Public title
The effect of 8 weeks of intense interval training with the consumption of aqueous extract of mango leaves on oxidative stress in overweight and obese men.
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
men with a body mass index of more than 25 percent, complete health, and no disease people with any diseases of blood pressure, diabetes, obesity, and atherosclerosis, not using supplements (vitamins and minerals, etc.) or medication.
Exclusion criteria:
Age
From 25 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
40 people were selected as the research sample and divided into 4 groups of 10 people in a simple way: 1- The first group: exercise + placebo 2- The second group: exercise + water extract of mango leaves 3- The third group: Aqueous extract of mango leaves 4- The fourth group: control
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Institute of Physical Education and Sports Sciences
Street address
Ostad Motahari St. - Mir Emad St. - Fifth Alley
City
tehran
Province
Tehran
Postal code
1587958711
Approval date
2023-11-21, 1402/08/30
Ethics committee reference number
IR/SSRI.REC.1402.260

Health conditions studied

1

Description of health condition studied
Overweight and obesity
ICD-10 code
(E00-E90)
ICD-10 code description
(E00-E90)

Primary outcomes

1

Description
NRF2.Oxidative stress
Timepoint
Pre-test and post-test
Method of measurement
blood draw

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Exercise + mango leaf extract
Category
Other

2

Description
Intervention group: Exercise + placebo
Category
Other

3

Description
Intervention group: Mango leaf extract
Category
Other

4

Description
Control group: No intervention. the witness
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Clubs, universities, health centers and also through the awareness of virtual space
Full name of responsible person
FATEMEH OMIDALI
Street address
Ayatollah Boroujerdi University
City
Borujerd
Province
Lorestan
Postal code
162
Phone
+98 916 968 1882
Email
omidali.fatemeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty of Sports Sciences and Health
Full name of responsible person
فاطمه شب خیز
Street address
karegar shomali
City
tehran
Province
Tehran
Postal code
162
Phone
+98 912 212 5428
Email
shabkhiz@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Sports Sciences and Health
Proportion provided by this source
1
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
Ayatollah Boroujerdi University
Full name of responsible person
fatemeh omidali
Position
preceptor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Ayatollah Boroujerdi University
City
borujerd
Province
Lorestan
Postal code
6817794518
Phone
+98 66 4246 8320
Email
omidali.fatemeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ayatollah Boroujerdi University
Full name of responsible person
fatemeh omidali
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Ayatollah Boroujerdi University
City
bouroujerd
Province
Lorestan
Postal code
68177794518
Phone
+98 66 4246 8320
Email
omidali.fatemeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
ayatollah bouroujeri
Full name of responsible person
fatemeh omidali
Position
coach
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Ayatollah Boroujerdi University
City
bourujerd
Province
Lorestan
Postal code
6817794518
Phone
+98 66 4246 8320
Fax
Email
omidali.fatemeh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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