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The effect of resistance training and sour tea (Hibiscus sabdariffa) consumption on leptin and adiponectin adipokines in hypertensive elderly men

Protocol summary

Study aim
The effect of 12 weeks of resistance training and sour tea consumption on body composition variables (weight, waist-to-hip ratio, fat percentage, body mass index), hemodynamic markers (systolic and diastolic blood pressure) and biochemical markers (leptin and adiponectin) is associated with high blood pressure in elderly men.
Design
A clinical trial with a control group, with parallel groups, unblinded, randomized, in four groups: resistance training, sour tea, resistance training + sour tea, control. The research randomizer software (www.randomizer.com) will be used for randomization.
Settings and conduct
The subjects of the resistance training and resistance training+sour tea groups performed the resistance training protocol for 12 weeks (3 days per week). Also, the subjects of the sour tea and resistance exercises + sour tea group will consume sour tea 2 times a day (each time 2 grams in 240 ml of water) for 12 weeks. All sports exercises will be done in the sports club, and Other measurements, such as blood sampling, will be performed in the cardiology clinic under the supervision of a specialist doctor.
Participants/Inclusion and exclusion criteria
Inclusion criteria: male, over 65 years old, suffering from high blood pressure, using controlled blood pressure drugs. Complete the informed consent form. Exclusion: history of cardiovascular surgeries, including balloon surgery, known metabolic and inflammatory diseases, consumption of alcoholic beverages and cigarettes, use of beta blockers, and participation in regular sports activities in the six months leading up to the study.
Intervention groups
Four groups: resistance training, sour tea, resistance taining+ sour tea, control
Main outcome variables
Hemodynamic (systolic and diastolic blood pressure), body composition (weight, waist-to-hip ratio, fat percentage, body mass index), and biochemical (adiponectin and leptin) markers.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230131057292N1
Registration date: 2023-06-19, 1402/03/29
Registration timing: prospective

Last update: 2023-06-19, 1402/03/29
Update count: 0
Registration date
2023-06-19, 1402/03/29
Registrant information
Name
Shima Mojtahedi
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 6111 8872
Email address
shmojtahedi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of resistance training and sour tea (Hibiscus sabdariffa) consumption on leptin and adiponectin adipokines in hypertensive elderly men
Public title
Effects of resistance training and sour tea consumption on hypertension
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Men aged between 55 and 70 years Hypertensive Taking hypertension drugs Completion of the informed consent form
Exclusion criteria:
using beta blockers drugs having a history of heart surgery suffering from metabolic diseases alcohol participating in regular physical activities in the six months before the time of the study smoking suffering from inflammatory diseases
Age
From 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, subjects are selected by Simple randomization by the random allocation rule. After determining the sample size, they will be equally divided into 4 groups. Using the lottery method, the names of the subjects are written on separate papers and placed in a container, then the names of the subjects are randomly taken out and placed in the intervention groups or placebo, respectively.
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
Ethics Committee in Research, Faculty of Physical Education and Sports Sciences, University of Tehra
Street address
Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic
City
Tehran
Province
Tehran
Postal code
1439813117
Approval date
2022-07-17, 1401/04/26
Ethics committee reference number
IR.UT.SPORT.REC.1401.017

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
Essential
ICD-10 code description
I10

Primary outcomes

1

Description
systolic an diastolic blood pressure
Timepoint
At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation
Method of measurement
Sphygmomanometer and stethoscope

2

Description
Serum leptin levels
Timepoint
At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation
Method of measurement
Using the human ELISA diagnostic kit related to the variable

3

Description
adiponectin
Timepoint
At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation
Method of measurement
Using the human ELISA diagnostic kit related to the variable

Secondary outcomes

1

Description
Weight changes
Timepoint
At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation
Method of measurement
scale

2

Description
Waist to hip ratio
Timepoint
At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation
Method of measurement
tape meter

3

Description
Body mass index
Timepoint
At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation
Method of measurement
Bioelectrical impedance device

4

Description
Fat index
Timepoint
At the beginning of the study (before the start of the intervention) and 12 weeks after the start of exercise or supplementation
Method of measurement
Bioelectrical impedance device

Intervention groups

1

Description
Intervention group: The training group will do 12 weeks and 3 sessions of resistance training program every week. Resistance exercises include 9 exercises (2 sets/12-15 repetitions) plus 10 minutes of warm-up and cool-down before and after exercise. The main training phase includes upper body exercises (chest press, latissimus dorsi pulldown, back row, biceps curl), lower body exercises (leg press, leg extension, leg curl) and middle body exercises (abdominal crunch, lower back extension). .
Category
Prevention

2

Description
Intervention group: Sour tea group for 12 weeks and daily consumption of 2 grams of sour tea dissolved in 240 ml of water.
Category
Prevention

3

Description
Intervention group: resistance exercises + sour tea for 12 weeks and will do resistance exercises 3 times a week. Resistance exercises include 9 exercises (2 sets/12-15 repetitions) plus 10 minutes of warm-up and cool-down before and after exercise. The main training phase includes upper body exercises (chest press, latissimus dorsi pulldown, back row, biceps curl), lower body exercises (leg press, leg extension, leg curl) and middle body exercises (abdominal crunch, lower back extension). . In addition, every day, 2 servings of sour tea will be consumed in the amount of 2 grams dissolved in 240 ml of water.
Category
Prevention

4

Description
Control group: The control group does not do resistance exercise and does not consume sour tea.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Tehran
Full name of responsible person
Shima Mojtahedi
Street address
North Kargar, Physical Education and Sport Sciences faculty
City
Tehran
Province
Tehran
Postal code
1439813117
Phone
+98 21 6111 8872
Email
shmojtahedi@ut.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Tehran
Full name of responsible person
Shima Mojtahedi
Street address
Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic
City
Tehran
Province
Tehran
Postal code
1439813117
Phone
+98 21 6111 8872
Email
shmojtahedi@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tehran
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
Ferdowsi University of Mashhad
Full name of responsible person
Babak Hoshmand moghaddam
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Iran, Mashhad, Azadi Sq, Ferdowsi university of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 5000
Email
b.hooshmand.m@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Shima Mojtahedi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic
City
Tehran
Province
Tehran
Postal code
1439813117
Phone
+98 21 6111 8872
Email
shmojtahedi@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Shima Mojtahedi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic
City
Tehran
Province
Tehran
Postal code
1439813117
Phone
+98 21 6111 8872
Email
shmojtahedi@ut.ac.ir

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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