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

November 27, 2023 updated by: reza kazemi, University of Tehran

Comparing the Effectiveness of Transcranial Direct Stimulation (tDCS) and Probiotic Supplementation on Risky Decision-making, Impulsivity, Self-control, and Food Selection in Overweight Adults

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 1969713663
        • Recruiting
        • Atieh neuroscience center
        • Contact:
        • Principal Investigator:
          • Sara Derafsheh, MSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: 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 Comparator: Probiotic supplementation
In this group, participants will consume 2 probiotic supplements (The synbiotics family) daily, for one month.
Drug: 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).
Experimental: 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.
Device: 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 Comparator: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body analysis test
Time Frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
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.
Balloon analogue risk task (BART)
Time Frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
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.
Impulsive Behavior Scale Questionnaire measuring Urgency, Premeditation (lack of), Perseverance (lack of), and Sensation seeking (UPPS)
Time Frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
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)
Time Frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
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.
Tangney self-control questionnaire (Form 36)
Time Frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
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.
Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tehran

Collaborators

University of Messina
Tabriz University

Investigators

  • Study Director: Marzieh Heysiattalab, PhD, University of Tabriz
  • Study Director: Reza Kazemi, PhD, University of Tehran
  • Principal Investigator: Sara Derafsheh, MSC, University of Tabriz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Overweight

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight and Obesity

Clinical Trials on tDCS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe