The effect of 12 weeks of high-intensity functional training (HIFT) and Ginkgo biloba consumption on serum levels of inflammatory indicators, antioxidant defense and physical performance in Yazd firefighters.
The general purpose of this study is to investigate the effect of 12 weeks of HIFT and Ginkgo biloba consumption on the serum levels of inflammatory indicators, antioxidant defense and physical performance in Yazd firefighters.
Design
Factorial randomized controlled trial with single-blind treatments on 48 firefighters
Settings and conduct
The current research is a factorial type. It will be done in 2*2 format. Two factors with two levels that will be implemented in four groups. The exercise factor (exercise vs. non-exercise) and the supplement factor (supplement consumption vs. non-supplement consumption) will be implemented as a pre-test and post-test in Yazd city. The data will be collected by laboratory and field method.
Participants/Inclusion and exclusion criteria
The inclusion criteria are: age group 25 to 50 years old, operational post, fire fighting experience of at least 3 years, not taking special and dietary supplements, not having clinical physiological and metabolic diseases.
The exclusion criteria are: suffering from certain diseases, consumption of sports and diet supplements during one year before the study, age less than 25 years and more than 50 years, fire fighting experience less than 3 years.
Intervention groups
1. High Intensity Functional Training (HIFT) . 2 HIFT with Ginkgo Biloba 3. Ginkgo Biloba 4. Control
Main outcome variables
Reduction of inflammatory indicators; Increase of antioxidant enzymes; Increasing aerobic fitness, Improving body composition.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230919059465N1
Registration date:2024-02-17, 1402/11/28
Registration timing:prospective
Last update:2024-02-17, 1402/11/28
Update count:0
Registration date
2024-02-17, 1402/11/28
Registrant information
Name
Hamid Sedaghat
Name of organization / entity
Islamic Azad University, Khorasgan branch
Country
Iran (Islamic Republic of)
Phone
+98 912 012 2943
Email address
hsedaghat9194@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-05-09, 1403/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 12 weeks of high-intensity functional training (HIFT) and Ginkgo biloba consumption on serum levels of inflammatory indicators, antioxidant defense and physical performance in Yazd firefighters.
Public title
Investigating the effect of 12 weeks of HIFT and Ginkgo biloba consumption on serum levels of inflammatory indicators and antioxidant defense
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All firefighters who are in the operational line, have more than 3 years of work experience, age range of 25 to 50 years, not suffering from specific physiological and metabolic diseases, not taking special dietary and sports supplements.
Exclusion criteria:
Work experience of less than 3 years, age less than 25 years and more than 50 years, suffering from a disabling disease from participating in training, taking special dietary and sports supplements
Age
From 1382 years old to 1352 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In the current research, the randomization method will be performed using the random sequence generation software method. Random allocation software is one of these software’s. In addition to simple randomization, random sequence generation software’s are capable of generating random sequences by block method. The randomization unit is individual. In the following, the concealment of random allocation is done by using sealed and opaque envelopes in a random sequence, which is called the SNOSE method. Finally, in the process of randomization in the present study, the person involved in creating the randomization program will be separate from other researchers to reduce possible bias.
Blinding (investigator's opinion)
Single blinded
Blinding description
The training place of the participants who are in the four groups will be separate from each other, the participants will not know the type and content of the supplement consumed. The data analyst will be unaware of the type of data that is related to which group and will not know what type of intervention the data is related to.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Isfahan, Khorasgan branch
Street address
University Blvd, Arghwanieh, East J Street, Isfahan, IRAN
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2023-10-31, 1402/08/09
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.297
Health conditions studied
1
Description of health condition studied
Inflammatory status and antioxidant defense
ICD-10 code
--
ICD-10 code description
--
Primary outcomes
1
Description
Lipocalin-2
Timepoint
Two stages: before the start of the study and after the end of 12 weeks of interference.
Method of measurement
Valid and standard lipocalin-2 laboratory kit
2
Description
Interleukin-8 (IL-8)
Timepoint
Two stages: before the start of the study and after the end of 12 weeks of intervention
Method of measurement
Valid and standard IL-8 laboratory kit
3
Description
Interleukin-1beta (IL-1β)
Timepoint
Two stages: before the start of the study and after the end of 12 weeks of intervention
Method of measurement
Valid and standard IL-1β laboratory kit
4
Description
Superoxide desmutase (SOD)
Timepoint
Two stages: before the start of the study and after the end of 12 weeks of intervention
Method of measurement
Valid and standard SOD laboratory kit
5
Description
Catalase (CAT)
Timepoint
Two stages: before the start of the study and after the end of 12 weeks of intervention
Method of measurement
Valid and standard CAT laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention: consists of performing high-intensity functional training (HIFT). The subjects of this intervention (12 people) perform HIFT exercises for 12 weeks and 4 sessions per week based on the principle of overload.. HIFT is a combination of aerobic and resistance training. Aerobic exercise will be performed with an intensity of 60 to 85% of the target heart rate. Resistance training will be performed with 70 to 90% of a maximum repetition. 48 hours before the start of the first training session, the subjects will go to a gym equipped with standard sports equipment to measure anthropometric characteristics, physical and physiological composition. Blood sampling will be done 24 hours before the first training session.
Category
Other
2
Description
The second intervention: consists of performing high-intensity functional training (HIFT) with Ginkgo biloba supplement (80 mg).The subjects of this intervention (12 people) will perform HIFT exercises for 12 weeks and 4 sessions per week based on the principle of overload and will receive Ginkgo biloba (80 mg) in the form of two capsules once a day along with training. Aerobic exercise will be performed with an intensity of 60 to 85% of the target heart rate. Resistance training will be performed with 70 to 90% of a maximum repetition. 48 hours before the start of the first training session, the subjects will go to a gym equipped with standard sports equipment to measure anthropometric characteristics, physical and physiological composition. Blood sampling will be done 24 hours before the first training session.
Category
Other
3
Description
The third intervention: Ginkgo biloba supplement (80 mg). The subjects of this intervention (12 people) will receive gincobiloba supplement (80 mg) on Saturday, Sunday, Tuesday and Wednesday in the form of two capsules per day for 12 weeks. Ginkgo biloba capsule contains 80 mg of standard Ginkgo biloba, including 19.2 mg of flavonoid glycoside (24%), 4.8 mg of terpene lactone (6%) and other substrates such as maltodextrin, microcrystalline cellulose and magnesium stearate.
Category
Other
4
Description
Control :The control group (12 people) does not participate in any intervention and performs its normal daily activities during the study (12 weeks). They will not participate in training programs and physical activities and will follow their normal daily diet. The placebo capsule will also contain microcrystalline cellulose, magnesium stearate and maltodextrin, which will be supplied in the same form and color as the supplement.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fire and Safety Services Organization of Yazd Municipality
Full name of responsible person
Hamid Sedaghat
Street address
Fire Department and Safety Services Organization of Yazd Municipality, Sultanpanah Square, Yazd, IRAN
City
Yazd
Province
Yazd
Postal code
8916715188
Phone
+98 35 3623 5396
Email
hsedaghat9194@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Toqyani
Street address
Islamic Azad University (Khorasgan branch), University Blvd, Arghwanieh, East Jey Street, Esfahan, IRAN.
City
Esfahan
Province
Isfehan
Postal code
کد پستی: ۳۹۹۹۸-۸۱۵۵۱
Phone
+98 31 3500 2000
Email
Research@khuisf.ac.ir
Web page address
https://isfahan.iau.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan, Islamic Azad University, Khorasgan branch