Protocol summary

Study aim
Determining the effect of eight weeks of high-intensity interval training and probiotic supplementation on serotonin receptor and transporter gene expression, serum serotonin concentration, and heart rate variability in inactive young women
Design
A randomized, non-blinded, phase 1, controlled clinical trial with three parallel groups on thirty healthy, inactive women. Randomization will be performed using individual coding and the data sorting function in statistical software.
Settings and conduct
The present study will be conducted in the form of an experimental design in the club of the Faculty of sport sciences, in two stages: pre-test and post-test. In the pre-test stage, the subjects' body composition, a five-minute electrocardiogram recording, blood sampling, taking blood pressure, completing a mood profile questionnaire, and a running speed test will be performed. Subjects will be divided into three groups: exercise group, supplement group, and supplement + exercise group. Then, interventions that include eight weeks of high-intensity interval training and probiotic supplementation will be performed for three days a week. In the post-test stage, all the tests mentioned in the pre-test stage will be performed.
Participants/Inclusion and exclusion criteria
Female gender, age 20-40 years, no exercise for 6 months; no history of neurological, cardiovascular, respiratory, metabolic diseases, or orthopedic problems
Intervention groups
The first group; high-intensity interval training, the second group; probiotic supplementation, the third group; high-intensity interval training + probiotic supplementation.
Main outcome variables
serum serotonin concentration, serotonin receptor gene expression, serotonin transporter gene expression, heart rate variability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250404065201N1
Registration date: 2025-04-10, 1404/01/21
Registration timing: prospective

Last update: 2025-04-10, 1404/01/21
Update count: 0
Registration date
2025-04-10, 1404/01/21
Registrant information
Name
Noushin zakeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3319 2709
Email address
zakeri.n@tabrizu.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2025-05-08, 1404/02/18
Expected recruitment end date
2025-05-18, 1404/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of HIIT trainings and probiotic supplementation on gene expression of receptors and plasma concentration of serotonin, and heart rate variability in sedentary young women
Public title
The role of changes in peripheral serotonin in the effects of HIIT training and probiotic supplementation on the cardiac autonomic nervous system
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
female gender age range of 20-40 years Having no exercise training for at least six months
Exclusion criteria:
Having a history of neurological diseases or autonomic nervous system disorders Cardiovascular diseases Respiratory diseases Metabolic diseases Having orthopedic problems
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, the stratified randomization method will be used. First, a numerical code will be assigned to each participant, and the numerical codes will be entered into the statistical software in order. After the pre-test stage, the obtained data will be recorded against the relevant codes in the statistical software and the data will be sorted from low to high values ​​using the ascending sorting icon. Finally, three subgroups (classes) of the total number of participants will be created based on body mass index (less than and equal to 25, higher than 25 and higher than 30) and some heart rate variability indices such as the ratio of high-frequency waves to low-frequency waves of the electrocardiogram (less than one, more than 2, between one and two), and from each subgroup (class), an equal number of participants will enter the main group in the form of numerical and anonymous codes. In this way, the division of groups is done in a homogeneous but random manner. For the purpose of allocation concealment, the numerical codes will not be identified by the researcher during grouping.
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 Medical Research, University of Tabriz
Street address
No.44, Jafary Alley, Baharestan Square, Shariaty Street, Valiasr
City
Tabriz
Province
East Azarbaijan
Postal code
5157674968
Approval date
2025-01-25, 1403/11/06
Ethics committee reference number
IR.TABRIZU.REC.1403.149

Health conditions studied

1

Description of health condition studied
The effect of eight weeks of HIIT trainings and probiotic supplementation on gene expression of receptors and plasma concentration of serotonin, and heart rate variability in sedentary young women
ICD-10 code
Z64.2
ICD-10 code description
Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmful

Primary outcomes

1

Description
Serum serotonin concentration
Timepoint
One day before and one day after eight weeks of interventions that included exercise and probiotic supplementation.
Method of measurement
A German-made LDN ELISA kit and an ELISA reader will be used to measure the quantitative concentration of serum serotonin.

2

Description
Blood serotonin receptor gene expression (5-HTR2A)
Timepoint
One day before and one day after eight weeks of interventions that included exercise and probiotic supplementation.
Method of measurement
Real-time polymerase chain reaction will be used to measure gene expression.

3

Description
Serotonin transporter gene expression (SERT)
Timepoint
One day before and one day after eight weeks of interventions that included exercise and probiotic supplementation.
Method of measurement
Real-time polymerase chain reaction will be used to measure gene expression.

4

Description
Heart rate variability
Timepoint
One day before and one day after eight weeks of interventions that included exercise and probiotic supplementation.
Method of measurement
A three-channel Holter monitor system, from Cantec company, model 9803TLC, made in China, will be used to measure heart rate variability.

Secondary outcomes

1

Description
Serum cortisol concentration
Timepoint
One day before and one day after eight weeks of exercise interventions and probiotic supplementation
Method of measurement
ELISA method by Monobind kit made in the USA

2

Description
Profile of mood state
Timepoint
One day before and one day after eight weeks of exercise interventions and probiotic supplementation
Method of measurement
Profile Of Mood State Questionnaire (Modified), 40 questions

3

Description
Body composition (fat mass, muscle mass)
Timepoint
One day before and one day after eight weeks of exercise interventions and probiotic supplementation
Method of measurement
Body Composition Scale, Xiaomi, S400-MJTZC01YM

4

Description
Blood Pressure
Timepoint
One day before and one day after eight weeks of exercise interventions and probiotic supplementation
Method of measurement
Omron digital blood pressure monitor

Intervention groups

1

Description
First intervention group: The first group will perform high-intensity interval training for eight weeks, three days (sessions) per week, for approximately 45 minutes per session, along with warm-up and cool-down exercises with the respective sports trainer at the gym.
Category
Prevention

2

Description
Second intervention group: The second group will receive probiotic supplements for eight weeks, three days each week, in the form of packaged capsules from Zist Takhmir Company in Tehran. Each capsule contains a total of 10^9 colonies per unit (CFU) of the total bacterial strains Lactobacillus acidophilus, Lactobacillus fermentum, Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus plantarum, Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium longum, and Bifidobacterium bifidum.
Category
Prevention

3

Description
Third intervention group: The third group will do high-intensity interval training along with probiotic supplementation for eight weeks, three days a week.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Physical Education, University of Tabriz
Full name of responsible person
Amirsasan, Ramin
Street address
Faculty of sport sciences, University of Tabriz, Imam Khomeini St, 29 Bahman Blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
srsc@tabrizu.ac.ir
Phone
+98 41 3339 3251
Fax
+98 41 3335 6008
Email
zakeri.n@tabrizu.ac.ir
Web page address
https://sports.tabrizu.ac.ir/f

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Tabriz
Full name of responsible person
Asgari, Asghar
Street address
University of Tabriz, Tabriz, 29 Bahman Blvd, Imam Khomeini St
City
Tabriz
Province
East Azarbaijan
Postal code
5157674968
Phone
+98 41 3339 2709
Fax
+98 41 3335 6008
Email
zakeri.n@tabrizu.ac.ir
Web page address
https://sports.tabrizu.ac.ir/f
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Tabriz
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
The University of Tabriz
Full name of responsible person
Zakeri, Noushin
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology, Sports Nutrition
Street address
No. 44, Jafari Ave, Baharestan Square, Shariati Street, Valiasr, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5157674968
Phone
+98 41 3319 2709
Email
zakeri.n@tabrizu.ac.ir
Web page address
https://sports.tabrizu.ac.ir/f

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Noushin Zakeri
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No.44, Jafari Ave, Baharestan Square, Shariati Street, Valiasr
City
Tabriz
Province
East Azarbaijan
Postal code
5157674968
Phone
+98 41 3319 2709
Fax
Email
noushin.zakeri.82@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Noushin Zakeri
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology, Sports Nutrition
Street address
No.44, Jafari Ave, Baharestan Square, Shariati Street, Valiasr
City
Tabriz
Province
East Azarbaijan
Postal code
5157674968
Phone
+98 41 3319 2709
Fax
Email
zakeri.n@tabrizu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A file related to part of the participants' heart rate variability data, a file related to part of the blood biochemical tests, genetics, and the informed consent form will be prepared as an attachment and will be sent upon request.
When the data will become available and for how long
The access period will begin 6 months after the results are published.
To whom data/document is available
Data will be available for researchers working at universities and scientific institutions.
Under which criteria data/document could be used
The documentation will be available for use by medical staff, especially neurologists or physiologists working in clubs, and will be made available to them upon request, subject to review of the conditions.
From where data/document is obtainable
To receive the data file, applicants can contact Ms. Noushin Zakeri at the email address noushin.zakeri.82@gmail.com.
What processes are involved for a request to access data/document
The applicant must provide documentation indicating the name of the university or scientific institution in which he/she is working and state his/her clear purpose for requesting raw data.
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