Effect of Transcranial Direct Current Stimulation (tDCS) and Probiotic Supplementation in Overweight Adults

University of Tehran

Status: Enrolling

Conditions: Overweight and Obesity

Treatments: Device: Sham tDCS; Device: tDCS; Drug: Probiotic Blend Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06035718

Overweight

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI over 25
• Higher than normal fat level

Exclusion criteria

• 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,
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

Active tDCS over the dorsolateral prefrontal cortex (DLPFC)

Experimental group

Description:

In this group, participants will receive active 2 milliampere (mA) tdcs over the DLPFC (anode on F3 and cathode onF4) for 20 minutes.

Treatment:

Device: tDCS

Active tDCS over the ventromedial prefrontal cortex (VMPFC)

Active Comparator group

Description:

In this group, participants will receive active 2 mA tdcs over the VMPFC (anode on Fpz and cathode on Cz) for 20 minutes.

Treatment:

Device: tDCS

Sham tDCS Stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: Sham tDCS

Probiotic supplementation

Active Comparator group

Description:

In this group, participants will consume 2 probiotic supplements (The synbiotics family) daily, for one month.

Treatment:

Drug: Probiotic Blend Capsule