Protocol summary

Study aim
The general purpose of this research is to determine the effect of eight weeks of intense interval training with white tea on inflammatory indicators, oxidative stress and muscle damage in men. He is overweight and obese.
Design
This research is applied in terms of goals and semi-experimental in terms of controlling research variables. Also, three groups (HIIT training group, white tea group and HIIT training group with white tea) will be randomly assigned in three groups of 12 people.
Settings and conduct
The statistical population of this study will be healthy middle-aged men aged 40 to 55 years old with overweight and obesity (BMI: 28-35 kg/m²) who are covered by health center number 6 of Urmia city, West Azarbaijan province. Subjects are homogenized based on body mass index, fat percentage and diet. After completing the consent form to participate in the research, health questionnaire, physical activity and 24-hour food diary and three-day record of food intake and making the necessary coordination with them, he helped in the process of assimilation of data and according to the plan for 10 weeks under the supervision of the researcher. They will start a HIIT training program and use white tea.
Participants/Inclusion and exclusion criteria
Not having any chronic diseases such as metabolic syndrome, definite heart disease and hospitalization or congenital history, no history of food allergy, use of drugs affecting inflammatory indicators, oxidative stress and muscle damage in the study
Intervention groups
Three groups (HIIT training group, white tea group and HIIT training group with white tea) will be randomly assigned in three groups of 12 people.
Main outcome variables
HIIT intense interval training; White tea; creatine kinase CK enzyme; LDH lactate dehydrogenase enzyme; interleukin-6 (IL-6); tumor necrosis factor-alpha (TNF-a); Malondialdehyde (MDA)

General information

Reason for update
Acronym
Tabriz HIIT & White Tea Study
IRCT registration information
IRCT registration number: IRCT20230228057569N1
Registration date: 2023-12-24, 1402/10/03
Registration timing: registered_while_recruiting

Last update: 2023-12-24, 1402/10/03
Update count: 0
Registration date
2023-12-24, 1402/10/03
Registrant information
Name
Mortaza Beirami
Name of organization / entity
The University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 44 3383 7095
Email address
mortaza.beirami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks intense interval training (HIIT) with white tea on inflammatory indices, oxidative stress and muscle damage in overweight and obesity men
Public title
The effect of eight weeks intense interval training (HIIT) with white tea on inflammatory indices, oxidative stress and muscle damage in overweight and obesity men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects will be selected from people who plan to participate in a sports program for the first time, or those who have been inactive, inactive, or inactive for more than a year. According to the questionnaire, they are medically healthy and do not have any metabolic or other diseases.
Exclusion criteria:
They have not used cigarettes, food supplements and therapeutic drugs in the last 3 months.
Age
From 40 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
After being informed and invited to participate in the sports plan and among the covered volunteers, after matching in terms of anthropometric characteristics (including fat percentage, body mass index, height and weight), not having any chronic diseases such as metabolic syndrome, disease 36 healthy inactive men with confirmed heart disease and a history of hospitalization or congenital, no history of food allergy, use of drugs affecting inflammatory indicators, oxidative stress and muscle damage, according to the objectives and nature of the research and taking into account previous studies and existing conditions and non-athletes are voluntarily selected from among the men covered by the health center and with the mentioned BMI and randomly assigned to the groups. For random allocation, between 00 and 36 will be our identification numbers. The first number in this domain is placed in group 1, the second number in group 2, the third number in group 3, and so on.
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
Research Ethics Committee of Tabriz University
Street address
Unit 7, Omid Apartment 7, 5 Jannatt Alley, Janet St., Matin St., Rodaki St
City
Orumieh
Province
West Azarbaijan
Postal code
5715653578
Approval date
2023-06-11, 1402/03/21
Ethics committee reference number
IR.TABRIZU.REC.1401.092

Health conditions studied

1

Description of health condition studied
Changes in inflammatory indices, oxidative stress and muscle damage in overweight and obese men
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Changes in inflammatory indices, oxidative stress and muscle damage
Timepoint
Measurement of inflammatory indices, oxidative stress and muscle damage before and after the intervention
Method of measurement
The activity of creatine kinase (CK) and lactate dehydrogenase (LDH) is estimated from the serum sample that was analyzed by ELISA and analyzer. The activity of creatine kinase (CK) and lactate dehydrogenase (LDH) is estimated from the serum sample that was analyzed by ELISA and analyzer.Oxidative stress marker malondialdehyde (MDA) is expressed by reaction with thiobarbituric acid (TBA).

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: intense interval training group, the whole protocol includes 10 weeks of running training. The first 2 weeks are intended to prepare the participants and the other 8 weeks cover the main course of treatment. The first two weeks start for initial preparation, which is to prepare for heavy training, intense interval training, with an intensity of 50 to 80% of the reserve heart rate.An intense periodic exercise program in the form of running (work) and walking (rest) with 45-second bursts of activity with an intensity of 80 to 90% of the reserve heart rate in the third and fourth weeks and 30-second bursts with an intensity of 90 to 100 The reserve heart rate percentage in the fifth to tenth weeks is considered for three sessions per week.
Category
Lifestyle

2

Description
The second intervention group: white tea group, the groups including white tea should consume bulk Chinese white tea for 10 weeks, three times a day (morning, noon and night) at the same time and one hour before meals.Each serving should include one cup (two grams) of dry white tea in 200 ml of 80 degree water.
Category
Lifestyle

3

Description
The third intervention group: intense interval training group with white tea. the whole protocol includes 10 weeks of running training. The first 2 weeks are intended to prepare the participants and the other 8 weeks cover the main course of treatment. The first two weeks start for initial preparation, which is to prepare for heavy training, intense interval training, with an intensity of 50 to 80% of the reserve heart rate.An intense periodic exercise program in the form of running (work) and walking (rest) with 45-second bursts of activity with an intensity of 80 to 90% of the reserve heart rate in the third and fourth weeks and 30-second bursts with an intensity of 90 to 100 The reserve heart rate percentage in the fifth to tenth weeks is considered for three sessions per week. the groups including white tea should consume bulk Chinese white tea for 10 weeks, three times a day (morning, noon and night) at the same time and one hour before meals.Each serving should include one cup (two grams) of dry white tea in 200 ml of 80 degree water.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Urmia Nano Pathobiology Laboratory
Full name of responsible person
Masoum Gholami
Street address
Unit 4, Omid Apartment 7, Gannat St. 5, Gannat St., Metin St., At the end of Rudaki St.
City
Urmia
Province
West Azarbaijan
Postal code
5715653578
Phone
+98 914 711 6938
Email
mortaza.beirami@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr. Ramin Amirsasan
Street address
4th Floor, Unit 4, Omid Apartment 7, Gannat St. 5, Gannat St., Matin St., At the end of Rudaki St.
City
Urmia
Province
West Azarbaijan
Postal code
5715653578
Phone
+98 914 711 6938
Email
mortaza.beirami@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
50
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
Iranian academic center for education culture and research
Full name of responsible person
Morteza Bairami
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Unit 7, 4th floor, Omid Apartment 7, Jannet Alley 5, Jannet St., Metin St., end of Rodaki St.
City
Urmia
Province
West Azarbaijan
Postal code
5715653578
Phone
+98 914 711 6938
Email
mortaza.beirami@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Morteza Bairami
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Unit 7, 4th floor, Omid Apartment 7, Jannet Alley 5, Jannet St., Metin St., end of Rodaki St.
City
Urmia
Province
West Azarbaijan
Postal code
5715653578
Phone
+98 914 711 6938
Email
mortaza.beirami@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Morteza Bairami
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Unit 7, 4th floor, Omid Apartment 7, Jannet Alley 5, Jannet St., Metin St., end of Rodaki St.
City
Urmia
Province
West Azarbaijan
Postal code
5715653578
Phone
+98 914 711 6938
Email
mortaza.beirami@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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