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The effect of continuous training with rice bran supplementation on selected physical fitness factors, some oxidative stress and hemodynamic indicators of overweight policemen

Protocol summary

Study aim
Determining the interactive effect of continuous training and supplementation of rice bran on selected physical fitness factors, some oxidative stress, and hemodynamic indicators of overweight policemen
Design
A randomized, one-blinded, controlled, semi-experimental with a parallel-group design of 80 overweight males. A lottery will be used for randomization.
Settings and conduct
This research is an applied quasi-experimental study and includes pre-test and post-test with 4 experimental groups in which the effect of independent variables of continuous training and supplementation of rice bran and a combination of the two on selected variables of physical fitness, some pressure indicators Oxidation, some hemodynamic parameters, lipid profile, fasting blood sugar and some inflammatory cytokines and hs-CRP in overweight 20- to 40-year-old police men will be assessed. It will be done in a specialized laboratory. Collaborative researchers will be blind to pre-test and post-test evaluations and the statistical expert will be blind to how individuals are assigned to the groups.
Participants/Inclusion and exclusion criteria
Body mass index 25 to 29.9 Not participating in regular sports activities for 2 years No chronic diseases No respiratory, metabolic, cardiovascular, renal, and hepatic diseases
Intervention groups
Continuous exercise + placebo (20 people), Rice bran supplement (20 people), Combination of Continuous Exercise + Supplement (20 people) placebo (20 people)
Main outcome variables
Aerobic power; Anaerobic power; Body composition; Malone dialdehyde; Superoxide dismutase; Glutathione peroxidase; Catalase; Systolic blood pressure; Diastolic blood pressure; Resting heart rate; Cholesterol; Triglyceride; HDL; LDL; Fasting blood sugar; Interleukin-6; Interleukin-1 beta; hs-CRP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211023052854N1
Registration date: 2021-11-27, 1400/09/06
Registration timing: retrospective

Last update: 2021-11-27, 1400/09/06
Update count: 0
Registration date
2021-11-27, 1400/09/06
Registrant information
Name
Mojtaba Moazami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3342 1726
Email address
moazami1400@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2021-11-13, 1400/08/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of continuous training with rice bran supplementation on selected physical fitness factors, some oxidative stress and hemodynamic indicators of overweight policemen
Public title
The effect of continuous training and rice bran on oxidative stress and hemodynamic indices of overweight men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having a body mass index between 25 and 29.9 Not participating in regular sports activities for 2 years Not having Chronic diseases No respiratory, metabolic, cardiovascular, renal and hepatic diseases
Exclusion criteria:
Age
From 20 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
80 policemen with overweight will be selected by available sampling method. Through a lottery (participants' names were written on paper and will be divided into 4 groups (3 intervention and 1 control groups) through random lottery)
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, responsible for collecting and processing the data, the type of intervention, and the participants in the research groups are unaware.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University -Rasht Branch
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2021-09-19, 1400/06/28
Ethics committee reference number
IR.IAU.RASHT.REC.1400.014

Health conditions studied

1

Description of health condition studied
fat
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
aerobic power
Timepoint
48 hours before intervention and 48 hours after 12 weeks of intervention
Method of measurement
Aerobic power in this study will be measured by a shuttle run test.

2

Description
anaerobic power
Timepoint
48 hours before intervention and 48 hours after 12 weeks of intervention
Method of measurement
Anaerobic power in this study will be measured by Rast test.

Secondary outcomes

1

Description
Oxidative stress indices
Timepoint
48 hours before intervention and 48 hours after 12 weeks of intervention
Method of measurement
Measurements will be taken between 7 and 8 in the morning as a 12-hour fast and in the form of a venous blood sample with the help of a syringe while sitting on a chair.

2

Description
blood pressure
Timepoint
48 hours before intervention and 48 hours after 12 weeks of intervention
Method of measurement
Subjects' systolic and diastolic blood pressure will be measured using a Beaur digital sphygmomanometer.

3

Description
Lipid profile
Timepoint
48 hours before intervention and 48 hours after 12 weeks of intervention
Method of measurement
Lipid profiles including LDL, HDL, TG, VLDL and cholesterol are measured enzymatically with the kit of Pars-Azmon Company (made in Iran-Karaj).

4

Description
Fasting blood sugar
Timepoint
48 hours before intervention and 48 hours after 12 weeks of intervention
Method of measurement
It will be tested by laboratory measurements in the blood serum

5

Description
inflammatory cytokines
Timepoint
48 hours before intervention and 48 hours after 12 weeks of intervention
Method of measurement
Measurement of cytokines using special IL-6 and IL-1β Diaclone kits made in France will be used according to the manufacturer's instructions and ELISA method.

6

Description
hs-CRP
Timepoint
48 hours before intervention and 48 hours after 12 weeks of intervention
Method of measurement
It is measured with the kit of Pars-Azmon Company (made in Iran-Karaj) and by enzymatic method.

Intervention groups

1

Description
Intervention group1: Medium intensity continuous exercises for 12 weeks, 3 sessions per week will be used. Each session of continuous training for 60 minutes of walking or running on a treadmill includes 10 minutes of warm-up with an intensity of 50 to 60% of maximum heart rate, 45 minutes with 60 to 70% of maximum heart rate and 5 minutes of cooling. Participants will be trained to maintain the intensity of the workout by adjusting the speed or incline of the treadmill. For each session, heart rate, speed and incline will be recorded
Category
Rehabilitation

2

Description
Intervention group 2: Rice bran group will receive 10 gram packages of rice bran supplement of Bijar Quatterm Company 80% extraction for 6 weeks consumption (twice daily). They are asked to consume one packet before breakfast and one packet before dinner, and if desired, pour 10 grams of each packet into their usual yogurt and consume it.
Category
Treatment - Other

3

Description
Intervention group 3: Combining continuous exercise with rice bran supplementation
Category
Treatment - Other

4

Description
Control group: placebo They will receive a placebo for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports Village
Full name of responsible person
Mojtaba Moazami Goodarzi
Street address
Mallard Road, Marlik Road, next to Mellat Bank, Sports Village
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 21 6516 0035
Email
moazami1400@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Seidavi
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
41476-54919
Phone
+98 13 3342 4086
Email
moazami1400@yahoo.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
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mojtaba Moazami Goodarzi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
41476-54919
Phone
+98 13 3342 4086
Email
moazami1400@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mojtaba Moazami Goodarzi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
41476-54919
Phone
+98 13 3342 4086
Email
moazami1400@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mojtaba Moazami Goodarzi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
41476-54919
Phone
+98 13 3342 4086
Email
moazami1400@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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