Effect of Transcranial Direct Current Stimulation (tDCS) and Probiotic Supplementation in Overweight Adults
NCT ID: NCT06035718
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-03-01
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active tDCS over the dorsolateral prefrontal cortex (DLPFC)
In this group, participants will receive active 2 milliampere (mA) tdcs over the DLPFC (anode on F3 and cathode onF4) for 20 minutes.
tDCS
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.
Active tDCS over the ventromedial prefrontal cortex (VMPFC)
In this group, participants will receive active 2 mA tdcs over the VMPFC (anode on Fpz and cathode on Cz) for 20 minutes.
tDCS
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 tDCS Stimulation
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.
Sham tDCS
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.
Probiotic supplementation
In this group, participants will consume 2 probiotic supplements (The synbiotics family) daily, for one month.
Probiotic Blend Capsule
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).
Interventions
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Probiotic Blend Capsule
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).
tDCS
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 tDCS
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.
Eligibility Criteria
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Inclusion Criteria
* Higher than normal fat level
Exclusion Criteria
* 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,
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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University of Messina
OTHER
Tabriz University
OTHER
University of Tehran
OTHER
Responsible Party
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reza kazemi
Assistant professor
Principal Investigators
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Marzieh Heysiattalab, PhD
Role: STUDY_DIRECTOR
University of Tabriz
Reza Kazemi, PhD
Role: STUDY_DIRECTOR
University of Tehran
Sara Derafsheh, MSC
Role: PRINCIPAL_INVESTIGATOR
University of Tabriz
Locations
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Atieh neuroscience center
Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Overweight
Identifier Type: -
Identifier Source: org_study_id