Protocol summary

Study aim
effect of 6 weeks of high intensity interval training with nano-curcumin supplement on antioxidant and lipid degradation in overweight girls
Design
Applicants will be registered.Then 60 eligible people selected and During a brief ingsession, they will familiarize with the type of design, method of performing the initial test (pre-test), attend training sessions and post-test. In this session, Subjects will complete the Research consent form and the General Health Questionnaire form.Then subjects will be randomly divided into 4 groups of exercise, exercise-supplement, supplement and control group. then biochemical tests and initial anthropometric measurements will be performed and The intervention will be performed for 6 weeks . Then Experiments will be repeated after 6 weeks and the data will be analyzed.
Settings and conduct
Participants will be trained at Shahid Chamran University'of Ahwaz for 6 weeks and 3 session per week.
Participants/Inclusion and exclusion criteria
Entry requirements: Having a BMI between 25 and 30 Kilograms per square meter Having physical and mental health Having low activity level Having age between 18 and 28 years Non-inclusion criteria: taking medicine or supplement , Alcohol and smoking Being infected various diseases
Intervention groups
The present study will be implemented in four groups: intervention group 1: training, intervention group 2: Supplement-training ,intervention group 3: Supplement, interventiongroup 4: control. training and supplement-training groups will be paid to high intensity interval training for 6 weeks.The supplement and exercise- supplement group will receive a 80 mg nano-curcumin capsule on a daily for 6 weeks.While the control group will not have any regular physical activity.
Main outcome variables
superoxide dismutase; glutathione peroxidase; glutathione; catalase; total antioxidant capacity, malondialdehyde

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180927041150N1
Registration date: 2019-08-29, 1398/06/07
Registration timing: prospective

Last update: 2019-08-29, 1398/06/07
Update count: 0
Registration date
2019-08-29, 1398/06/07
Registrant information
Name
Somaye Fakhri
Name of organization / entity
Shahid Chamran University
Country
Iran (Islamic Republic of)
Phone
+98 71 3750 0104
Email address
fakhri.somayeh1992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-05, 1398/06/14
Expected recruitment end date
2019-09-19, 1398/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 6 weeks of high intensity training on supplementation of nano-curcumin on anti-oxidative and lipid peroxidation indices in overweight girls
Public title
The effect of high intensity training with taking curcumin supplement on oxidative defense and lipid degradation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a BMI between 25 and 30 Kilograms per square meter Having physical and mental health Having low activity level Having age between 18 and 28 years
Exclusion criteria:
taking medicine or supplement , Alcohol and smoking Being infected various diseases Such as diabetes, thyroid, hypertension, respiratory heart disease
Age
From 18 years old to 28 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, a simple randomization method will be used. The participants will be divided into 4 groups of 15 people. For this purpose, It is written from 1 to 4 numbers, ( There are 15 Repeat from each number) on the paper. Participants are asked that Each person take a number. so They will be grouped based on the number they picked.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Chamran University of ahvaz
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
IR.AJUMS.REC.1396.85899

Health conditions studied

1

Description of health condition studied
obosity and overweight
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Malondialdehyde was considered as a lipid degradation mark.
Timepoint
Measurement of malondialdehyde levels prior to the start of a 6-week training period and 48 hours after the end of the training period
Method of measurement
Laboratory and spectrophotometric method

2

Description
Superoxide dismutase was considered as an antioxidant index.
Timepoint
Measurement of superoxide dismutase levels prior to the beginning of the 6-week training period and 48 hours after the end of the training period
Method of measurement
Laboratory

3

Description
Glutathione peroxidase was considered as an anxiolytic agent.
Timepoint
Measurement of glutathione peroxidase levels before the beginning of the 6-week training period and 48 hours after the end of the training period.
Method of measurement
Laboratory

4

Description
Catalase was considered as an anxiolytic agent.
Timepoint
Measurement of catalase levels before the beginning of the 6-week training period and 48 hours after the end of the training period.
Method of measurement
Laboratory

5

Description
Glutathione was considered as an anxiolytic agent.
Timepoint
Measurement of glutathione levels before the start of the 6-week training period and 48 hours after the end of the training period
Method of measurement
Laboratory

6

Description
Total antioxidant capacity was considered as anxiolytic index.
Timepoint
Measurement of total antioxidant capacity levels before the start of the 6-week training period and 48 hours after the end of the training period
Method of measurement
Laboratory

Secondary outcomes

empty

Intervention groups

1

Description
The training group will perform high intensity interval training with 85% to 95% maximum heart rate for 6 weeks (3 sessions per week)
Category
Prevention

2

Description
The training-supplement group will perform high intensity interval training with 85% to 95% maximum heart rate for 6 weeks (3 sessions per week) also They will receive an 80-mg capsule of nano-curcumin daily
Category
Prevention

3

Description
Intervention group: Supplement, this group will receive an 80-mg capsule of nano-curcumin daily
Category
Prevention

4

Description
Control group: This group will not have regular physical activity and will not receive any supplement.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Chamran University of Ahvaz
Full name of responsible person
ُSomaye Fakhri
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Phone
+98 71 3750 0104
Email
fakhri.somaye1992@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Chamran university of Ahvaz
Full name of responsible person
Saeed Shakeryan
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Phone
+98 61 3333 0012
Email
sashakeryan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Chamran university of Ahvaz
Proportion provided by this source
100
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
Shahid Chamran university of Ahvaz
Full name of responsible person
Somaye Fakhri
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Phone
+98 71 3750 0104
Email
fakhri.somaye@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Chamran university of Ahvaz
Full name of responsible person
Somaye Fakhri
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Phone
+98 71 3750 0104
Email
fakhri.somaye1992@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Chamran university of Ahvaz
Full name of responsible person
Somaye Fakhri
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Phone
+98 71 3750 0104
Email
fakhri.somaye1992@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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