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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Probiotic Blend Capsule

tDCS

Sham tDCS

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring transcranial direct current stimulation, obesity, overweight, impulse control

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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.

Sites / Locations

Atieh neuroscience centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Sham Comparator

Active Comparator

Arm Label

Active tDCS over the dorsolateral prefrontal cortex (DLPFC)

Active tDCS over the ventromedial prefrontal cortex (VMPFC)

Sham tDCS Stimulation

Probiotic supplementation

Arm Description

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

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

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.

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT06035718

First Posted

September 6, 2023

Last Updated

September 13, 2023

Sponsor

University of Tehran

Collaborators

University of Messina, Tabriz University

1. Study Identification

Unique Protocol Identification Number

NCT06035718

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2023 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Tehran

Collaborators

University of Messina, Tabriz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity

Keywords

transcranial direct current stimulation, obesity, overweight, impulse control

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS over the dorsolateral prefrontal cortex (DLPFC)

Arm Type

Experimental

Arm Description

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

Arm Title

Active tDCS over the ventromedial prefrontal cortex (VMPFC)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sham tDCS Stimulation

Arm Type

Sham Comparator

Arm 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.

Arm Title

Probiotic supplementation

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Probiotic Blend Capsule

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

tDCS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham tDCS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Body analysis test

Description

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.

Time Frame