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| Name | Class |
|---|---|
| University of Messina | OTHER |
| Tabriz University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Probiotic supplementation | Active Comparator | In this group, participants will consume 2 probiotic supplements (The synbiotics family) daily, for one month. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Blend Capsule | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abed Hadipour Lakmehsari, PhD | Contact | 3883041384 | +39 | ahadipourlakmehsari@unime.it |
| Name | Affiliation | Role |
|---|---|---|
| Marzieh Heysiattalab, PhD | University of Tabriz | Study Director |
| Reza Kazemi, PhD | University of Tehran | Study Director |
| Sara Derafsheh, MSC |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atieh neuroscience center | Recruiting | Tehran | 1969713663 | Iran |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| tDCS | Device | 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. |
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| Sham tDCS | Device | 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. |
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| Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group. |
| University of Tabriz |
| Principal Investigator |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |