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

NCT06035718 | Unknown

• 1 other identifier: Overweight
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

transcranial direct current stimulation; obesity; overweight; impulse control

Outcome Measures

Primary Outcomes (5)

• 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.

  Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.

Study Arms (4)

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.

Device: tDCS

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.

Device: tDCS

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.

Device: Sham tDCS

Probiotic supplementation

ACTIVE COMPARATOR

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

Drug: Probiotic Blend Capsule

Interventions

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).

Probiotic supplementation

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.

Active tDCS over the dorsolateral prefrontal cortex (DLPFC); Active tDCS over the ventromedial prefrontal cortex (VMPFC)

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.

Sham tDCS Stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI over 25
• Higher than normal fat level

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Tehran: lead
• University of Messina: collaborator
• Tabriz University: collaborator

Study Sites (1)

Atieh neuroscience center

Tehran, 1969713663, Iran

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Marzieh Heysiattalab, PhD

  University of Tabriz

  STUDY DIRECTOR

• Reza Kazemi, PhD

  University of Tehran

  STUDY DIRECTOR

• Sara Derafsheh, MSC

  University of Tabriz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abed Hadipour Lakmehsari, PhD

CONTACT

3883041384; ahadipourlakmehsari@unime.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: March 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)