Overweight and ObesityNCT06035718
Effect of Transcranial Direct Current Stimulation (tDCS) and Probiotic Supplementation in Overweight Adults
A study testing Probiotic Blend Capsule and tDCS in people with Overweight and Obesity, run by University of Tehran at 1 site in Iran.
Trial summary
The aim of the current study is to investigate and compare the effectiveness of probiotic supplementation and tDCS stimulation on risky decision-making related to food choices in overweight people. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Probiotic Blend Capsule and tDCS
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI over 25
- Higher than normal fat level
Who cannot join
- Pregnancy
- Breastfeeding
- Smoking more than 10 cigarettes a day
- Excessive consumption of alcohol
- Suffering from chronic cardiovascular and kidney diseases
- Chronic digestive diseases such as celiac disease,
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- Chronic inflammatory bowel diseases such as colitis, intestinal surgery, cancer, etc.
- Suffering from acute and chronic diarrhea in the last one month
- Taking antibiotics in two months before the start of the study,
- Continuous use of prebiotic and probiotic products and drugs in one month before the start of the intervention
- Frequent use of antibiotics during the last month before the start of the intervention
- Taking weight loss medications and following a special slimming diet in the last 3 months before the intervention.
- History of epilepsy and seizures, stroke,
- Use of pacemaker
- Presence of metal implanted in the scalp or brain,
- Presence of skin lesions at the tDCS stimulation site, and history of head injury or brain surgery.
- Brain disorders and long-term and chronic use of neuropsychiatric drugs.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Atieh neuroscience center
Tehran, 1969713663
Reza Kazemi, PHD, 009802184012121, rezakazemi@ut.ac.ir
Sara Derafsheh, MSC
About this study
Official title: Comparing the Effectiveness of Transcranial Direct Stimulation (tDCS) and Probiotic Supplementation on Risky Decision-making, Impulsivity, Self-control, and Food Selection in Overweight Adults
The aim of the current study is to investigate and compare the effectiveness of probiotic supplementation and tDCS stimulation on risky decision-making related to food choices in overweight people. Considering the relatively established communication and interaction between the gut-brain-microbiome axis, the investigators expect that transcranial direct current stimulation and probiotic supplementation can both improve decision-making (decrease risky and impulsive decisions) and increase self-control in overweight people.
- Conditions
- Overweight and Obesity
- Being tested
- Probiotic Blend Capsule, tDCS, Sham tDCS
- Keywords
- transcranial direct current stimulation, obesity, overweight, impulse control
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Blend CapsuleDrug
By a probiotic blend capsule a specific product is intended which contains the following: Lactobacillus rhamnosus Lactobacillus plantarum Lactobacillus casei Lactobacillus helveticus Lactobacillus acidophilus Lactobacillus bulgaricus Lactobacillus gasseri Bifidobacterium bifidum Bifidobacterium lactis Bifidobacterium breve Bifidobacterium longum Streptococcus thermophile Fructooligosaccharides (FOS).
tDCSDevice
Using a tDCS device, a mild direct electric current is going to be non-invasively administered to the brain using rubber electrodes placed over the scalp.
Sham tDCSDevice
Using a tDCS device, a mild direct electric current is going to be non-invasively administered to the brain using rubber electrodes placed over the scalp. At this arm the electric current will be applied for a very short time (30 s) after which the device will turn off, thus providing the initial tingling sensation over the scalp but not interfering with the ongoing brain activity.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS over the dorsolateral prefrontal cortex (DLPFC) | Experimental | In this group, participants will receive active 2 milliampere (mA) tdcs over the DLPFC (anode on F3 and cathode onF4) for 20 minutes. Receives: Device: tDCS |
| Active tDCS over the ventromedial prefrontal cortex (VMPFC) | Active comparator | In this group, participants will receive active 2 mA tdcs over the VMPFC (anode on Fpz and cathode on Cz) for 20 minutes. Receives: Device: tDCS |
| Sham tDCS Stimulation | Sham comparator | In this group, participants will receive sham tDCS which will ramp up for 30 s at the beginning of the session and then ramp down and be switched off during the 20-minute stimulation session. Receives: Device: Sham tDCS |
| Probiotic supplementation | Active comparator | In this group, participants will consume 2 probiotic supplements (The synbiotics family) daily, for one month. Receives: Drug: Probiotic Blend Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body analysis test
This is a technique to determine the percentage of body mass that is fat compared to muscle. It can also indicate where the fat and muscle are carried within the body.
Measured: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
Impulsive Behavior Scale Questionnaire measuring Urgency, Premeditation (lack of), Perseverance (lack of), and Sensation seeking (UPPS)
This is a self-report tool that assesses five subscales (urgency, premeditation, perseverance, sensation seeking, and positive urgency) that are used to measure five distinct dimensions of impulsive behavior; each scale ranging from 4 to 16); Higher scores represent worse outcome.
Measured: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
Eating attitudes Test (EAT-26)
This tool is used to identify the presence of "eating disorder risk" based on attitudes, feelings and behaviours related to eating. The total score (between 0 and 78) provides an overall risk score, where higher scores indicating greater risk of an eating disorder.
Measured: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
Balloon analogue risk task (BART)
BART is a computerized decision-making task that is used to assess risk-taking behavior. The BART simulates a real-world situation, involving actual risky behavior, where taking a risk up until a certain point yields a reward.
Measured: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
Tangney self-control questionnaire (Form 36)
This is a self-report measurement to assess individual differences in traits of self-control. Scores range from 0 to 144 with higher scores representing worse outcome.
Measured: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Mar 2023
- Primary completionJul 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tehran
- Sponsor type
- University, hospital or other
- Collaborators
- University of Messina, Tabriz University
- Responsible party
- Principal investigator, reza kazemi, University of Tehran
- Investigators
- Marzieh Heysiattalab, PhD, Study director, University of TabrizReza Kazemi, PhD, Study director, University of TehranSara Derafsheh, MSC, Principal investigator, University of Tabriz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035718
- Sponsor's protocol ID
- Overweight
- Status last verified
- Nov 2023
- First submitted
- 6 Sep 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Transcranial Direct Stimulation (tDCS) and Probiotic Supplementation on Risky Decision-making, Impulsivity, Self-control, and Food Selection in Overweight Adults
- ClinicalTrials.gov ID
- NCT06035718
- Acronym / sponsor ID
- Overweight
- Conditions
- Overweight and Obesity
- Keywords
- transcranial direct current stimulation, obesity, overweight, impulse control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of TehranUniversity, hospital or other
- Collaborators
- University of Messina, Tabriz University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current study is to investigate and compare the effectiveness of probiotic supplementation and tDCS stimulation on risky decision-making related to food choices in overweight people. Considering the relatively established communication and interaction between the gut-brain-microbiome axis, the investigators expect that transcranial direct current stimulation and probiotic supplementation can both improve decision-making (decrease risky and impulsive decisions) and increase self-control in overweight people.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active tDCS over the dorsolateral prefrontal cortex (DLPFC) | Experimental | Device: tDCSIn this group, participants will receive active 2 milliampere (mA) tdcs over the DLPFC (anode on F3 and cathode onF4) for 20 minutes. |
| Active tDCS over the ventromedial prefrontal cortex (VMPFC) | Active comparator | Device: tDCSIn this group, participants will receive active 2 mA tdcs over the VMPFC (anode on Fpz and cathode on Cz) for 20 minutes. |
| Sham tDCS Stimulation | Sham comparator | Device: Sham tDCSIn this group, participants will receive sham tDCS which will ramp up for 30 s at the beginning of the session and then ramp down and be switched off during the 20-minute stimulation session. |
| Probiotic supplementation | Active comparator | Drug: Probiotic Blend CapsuleIn this group, participants will consume 2 probiotic supplements (The synbiotics family) daily, for one month. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI over 25
- Higher than normal fat level
Key exclusion criteria (17 listed)
- Pregnancy
- Breastfeeding
- Smoking more than 10 cigarettes a day
- Excessive consumption of alcohol
- Suffering from chronic cardiovascular and kidney diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Blend CapsuleBy a probiotic blend capsule a specific product is intended which contains the following: Lactobacillus rhamnosus Lactobacillus plantarum Lactobacillus casei Lactobacillus helveticus Lactobacillus acidophilus Lactobacillus bulgaricus Lactobacillus gasseri Bifidobacterium bifidum Bifidobacterium lactis Bifidobacterium breve Bifidobacterium longum Streptococcus thermophile Fructooligosaccharides (FOS). | Drug | Probiotic supplementation |
| tDCSUsing a tDCS device, a mild direct electric current is going to be non-invasively administered to the brain using rubber electrodes placed over the scalp. | Device | Active tDCS over the dorsolateral prefrontal cortex (DLPFC), Active tDCS over the ventromedial prefrontal cortex (VMPFC) |
| Sham tDCSUsing a tDCS device, a mild direct electric current is going to be non-invasively administered to the brain using rubber electrodes placed over the scalp. At this arm the electric current will be applied for a very short time (30 s) after which the device will turn off, thus providing the initial tingling sensation over the scalp but not interfering with the ongoing brain activity. | Device | Sham tDCS Stimulation |
Primary outcome
Body analysis test
Time frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
This is a technique to determine the percentage of body mass that is fat compared to muscle. It can also indicate where the fat and muscle are carried within the body.
Impulsive Behavior Scale Questionnaire measuring Urgency, Premeditation (lack of), Perseverance (lack of), and Sensation seeking (UPPS)
Time frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
This is a self-report tool that assesses five subscales (urgency, premeditation, perseverance, sensation seeking, and positive urgency) that are used to measure five distinct dimensions of impulsive behavior; each scale ranging from 4 to 16); Higher scores represent worse outcome.
Eating attitudes Test (EAT-26)
Time frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
This tool is used to identify the presence of "eating disorder risk" based on attitudes, feelings and behaviours related to eating. The total score (between 0 and 78) provides an overall risk score, where higher scores indicating greater risk of an eating disorder.
Balloon analogue risk task (BART)
Time frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
BART is a computerized decision-making task that is used to assess risk-taking behavior. The BART simulates a real-world situation, involving actual risky behavior, where taking a risk up until a certain point yields a reward.
Tangney self-control questionnaire (Form 36)
Time frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
This is a self-report measurement to assess individual differences in traits of self-control. Scores range from 0 to 144 with higher scores representing worse outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marzieh Heysiattalab, PhD study director
University of Tabriz
Reza Kazemi, PhD study director
University of Tehran
Sara Derafsheh, MSC principal investigator
University of Tabriz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Blend Capsule and tDCS in people with Overweight and Obesity, run by University of Tehran at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abed Hadipour Lakmehsari, PhD (3883041384 ext. +39, ahadipourlakmehsari@unime.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body analysis test (time frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.