Protocol summary

Study aim
The effect of direct current and transcranial pulse stimulation and exercise training on food cravings, impulsivity, risk-taking decision making, food preference, appetite, and cognitive flexibility in obese and overweight women
Design
A controlled, parallel-group, double-blind clinical trial on 15 patients. The website randomization.com will be used for randomization.
Settings and conduct
This study will be conducted at Razi University, each subject will be exposed to 3 different conditions of electrical stimulation of the brain in a random order and then, will perform a 30-minute endurance activity.
Participants/Inclusion and exclusion criteria
Criteria for entering the research: Age range from 18 to 50 years A resident of Kermanshah Body mass index (BMI) between 25 and 39.9 kg/m2 Being right-handed Having food cravings Obtaining a certificate of non-prohibition of participation in sports training program from the doctor Criteria for not entering the research: History of seizures, epilepsy or other types of neurological diseases The presence of implantable devices or pacemakers in the body Smoking, alcohol and drugs Abnormalities or musculoskeletal disorders Participation in weight loss programs in the past 6 months Participating in a regular exercise program in the past 6 months Menopause
Intervention groups
This study is an intra-group and counterbalanced study in which the subjects are exposed to 3 different conditions of brain stimulation including: 1) direct current anodal stimulation, 2) pulsed current anodal stimulation, 3) sham stimulation (placebo effect) in the DLPFC region. will be placed. The duration of stimulation will be 20 minutes and its intensity will be 2 mA.
Main outcome variables
Changes in food craving, impulsivity, risk-taking decision-making, food preference, appetite, and cognitive flexibility

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240424061555N1
Registration date: 2024-05-02, 1403/02/13
Registration timing: prospective

Last update: 2024-05-02, 1403/02/13
Update count: 0
Registration date
2024-05-02, 1403/02/13
Registrant information
Name
Sahar Bakhti
Name of organization / entity
Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 3825 4703
Email address
shrbkhty29@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-14, 1403/02/25
Expected recruitment end date
2024-05-29, 1403/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of one session of aerobic exercise with transcranial direct or pulsed current stimulation on food craving, food preference, and some psycho-cognitive factors related to appetite control in overweight and obese women
Public title
The effects of an aerobic exercise session with transcranial stimulation on food cravings in women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 18 to 50 years resident of Kermanshah Body mass index (BMI) between 25 and 39.9 kg/m2 Being right-handed (the dominant hand should be the right hand) Having food cravings Obtaining a certificate of non-prohibition of participation in the exercise program from the doctor
Exclusion criteria:
History of seizures, epilepsy or other types of neurological diseases The presence of implantable devices or pacemakers in the body Smoking, alcohol and drugs Abnormalities or musculoskeletal disorders Participation in weight loss programs in the past 6 months Participating in a regular exercise program in the past 6 months Menopause
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the order of subjects' exposure to 3 different conditions (3 different types of electrical stimulation of the brain) will be randomized by the Latin Squares method. To do so, first using the site www.random.org, a number between 1 and 15 will be randomly allocated to each subject as an identification code. Then, the English letters A, B, and C will be assigned to the three intervention conditions and a Latin Square will be created. In this case, a Latin square with three rows and three columns is created. Finally, participants 1 to 5 will be placed in the sequence of the first row, participants 6 to 10 will be placed in the sequence of the second row, and participants 11 to 15 will be placed in the sequence of the third row.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, the researcher and participants will be blinded to the type of transcranial electrical stimulation used and the location of stimulation in each session. In this study, the Neurostim stimulation device will be used to induce direct current electrical stimulation in three separate sessions and three different modes including: 1) direct current anodal stimulation, 2) pulsed current anodal stimulation, 3) sham stimulation (placebo effect) became. For this purpose, a person outside the research team will be responsible for applying electrical stimulation in three test sessions. In order to blind the participants, after they sit on a special chair, the stimulating device is hidden from their view and is completely covered by a cover, and the electrodes are placed on the desired areas by the examiner. In order to blind the researcher, before the intervention, the researcher leaves the laboratory and returns to the test site after the stimulation period has passed and the electrodes are removed and the stimulation device is turned off. Also, in sham stimulation mode, according to standard protocols, active current is induced on the head for 30 seconds in order to induce the same sensation as in active stimulation mode, and then the current is cut off and the stimulation is deactivated.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Razi University Research Ethics Committee
Street address
Taq Bostan, University Street, Razi University, Faculty of Sports Sciences, Room 73
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2024-03-06, 1402/12/16
Ethics committee reference number
IR.RAZI.REC.1403.001

Health conditions studied

1

Description of health condition studied
Obesity and overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Changes in food cravings
Timepoint
before and after and 24 and 48 hours after interventions
Method of measurement
15-item food craving questionnaire and 12-item visual analogue food craving questionnaire

2

Description
Food preference
Timepoint
Before and after interventions
Method of measurement
Online application of the Leeds Food Preference Questionnaire

3

Description
appetite
Timepoint
before and immediately and 1, 2, 4, 24 and 48 hours after the interventions
Method of measurement
Visual analogue subjective scale of appetite

Secondary outcomes

1

Description
impulsiveness
Timepoint
Before and after interventions
Method of measurement
Go/No go cognitive test software

2

Description
Risky decision making
Timepoint
Before and after interventions
Method of measurement
Iowa gambling cognitive test software

3

Description
Cognitive flexibility
Timepoint
Before and after interventions
Method of measurement
20-question cognitive flexibility questionnaire

4

Description
sense of pleasure
Timepoint
before applying interventions and every 3 minutes during aerobic exercise and immediately and 1, 2, 4, 24 and 48 hours after the end of aerobic exercise
Method of measurement
11-item emotion scale

5

Description
Arousal level
Timepoint
before applying interventions and every 3 minutes during aerobic exercise and immediately and 1, 2, 4, 24 and 48 hours after the end of aerobic exercise
Method of measurement
6-point scale of perceived arousal

Intervention groups

1

Description
Intervention group: In this research, all subjects will be exposed to two intervention conditions less than 7 days apart, including 1) direct current anodal electroencephalogram, 2) pulse anodal electroencephalogram. In both conditions, the movement time will be 20 minutes and its intensity will be 2 mA. In order to move, he will be treated with the Norastim movement device made by Medina Teb Company. The target areas in the brain are identified using the international brain mapping system 20-10, and the movement of the targeted areas is done using two special movement electrodes and an electroencephalogram cap.
Category
Treatment - Devices

2

Description
Control group: In this study, in addition to two intervention sessions, all subjects were exposed to a control session including sham electrical brain stimulation (placebo effect). All details of the control session will be similar to the intervention sessions, except that in the control session, the brain is not electrically stimulated and the electrical current of the stimulator device will be deactivated after 30 seconds. The duration of control conditions will also be 20 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Sports Sciences, Razi University
Full name of responsible person
Ehsan Amiri
Street address
Taq Bostan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
e.amiri@razi.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Dr. Mostafa Mostafai
Street address
Taq Bostan, University Street
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Email
b.mostafaei@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University of Kermanshah
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
Razi university of Kermanshah
Full name of responsible person
Ehsan Amiri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Taq Bostan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4585
Email
e.amiri@razi.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi university of Kermanshah
Full name of responsible person
Ehsan Amiri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Taq Bostan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4585
Email
e.amiri@razi.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Ehsan Amiri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Taq Bostan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4585
Email
e.amiri@razi.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All data can be shared after de-identifying the subjects.
When the data will become available and for how long
6-9 months after printing the results
To whom data/document is available
The head of the research team and executive researcher
Under which criteria data/document could be used
Meta-analysis
From where data/document is obtainable
If you need to receive documents, send an email to Ehsan Amiri, a member of the scientific faculty of Razi University, with the email address: e.amiri@razi.ac.ir.
What processes are involved for a request to access data/document
In case of an official request, stating the relevant reasons and mentioning the complete details, the data will be sent via email after 72 hours.
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