Clinical trial NCT06035718: Effect of Transcranial Direct Current Stimulation (tDCS) and Probiotic Supplementation in Overweight Adults
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: transcranial direct current stimulation
obesity
overweight
impulse control
Lead sponsor: University of Tehran
Sponsor class: OTHER
Collaborators: name: University of Messina
name: Tabriz University
First posted: 2023-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body analysis test
timeFrame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
measure: Impulsive Behavior Scale Questionnaire measuring Urgency, Premeditation (lack of), Perseverance (lack of), and Sensation seeking (UPPS)
timeFrame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
measure: Eating attitudes Test (EAT-26)
timeFrame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
measure: Balloon analogue risk task (BART)
timeFrame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
measure: Tangney self-control questionnaire (Form 36)
timeFrame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Atieh neuroscience center
Study officials:
affiliation: University of Tabriz
name: Marzieh Heysiattalab, PhD
role: STUDY_DIRECTOR
affiliation: University of Tehran
name: Reza Kazemi, PhD
role: STUDY_DIRECTOR
affiliation: University of Tabriz
name: Sara Derafsheh, MSC
role: PRINCIPAL_INVESTIGATOR
References: