Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06035718
Status:
UNKNOWN
Last Update Posted:
2023-11-28
First Post:
2023-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Transcranial Direct Current Stimulation (tDCS) and Probiotic Supplementation in Overweight Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2023-09-06', 'studyFirstSubmitQcDate': '2023-09-06', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body analysis test', 'timeFrame': 'Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.', '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.'}, {'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.', 'description': '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.'}, {'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.', 'description': '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.'}, {'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.', 'description': '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.'}, {'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.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcranial direct current stimulation', 'obesity', 'overweight', 'impulse control'], 'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI over 25\n* Higher than normal fat level\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding\n* Smoking more than 10 cigarettes a day\n* Excessive consumption of alcohol\n* Suffering from chronic cardiovascular and kidney diseases\n* Chronic digestive diseases such as celiac disease,\n* Chronic inflammatory bowel diseases such as colitis, intestinal surgery, cancer, etc.\n* Suffering from acute and chronic diarrhea in the last one month\n* Taking antibiotics in two months before the start of the study,\n* Continuous use of prebiotic and probiotic products and drugs in one month before the start of the intervention\n* Frequent use of antibiotics during the last month before the start of the intervention\n* Taking weight loss medications and following a special slimming diet in the last 3 months before the intervention.\n* History of epilepsy and seizures, stroke,\n* Use of pacemaker\n* Presence of metal implanted in the scalp or brain,\n* Presence of skin lesions at the tDCS stimulation site, and history of head injury or brain surgery.\n* Brain disorders and long-term and chronic use of neuropsychiatric drugs.'}, 'identificationModule': {'nctId': 'NCT06035718', 'briefTitle': 'Effect of Transcranial Direct Current Stimulation (tDCS) and Probiotic Supplementation in Overweight Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Tehran'}, 'officialTitle': 'Comparing the Effectiveness of Transcranial Direct Stimulation (tDCS) and Probiotic Supplementation on Risky Decision-making, Impulsivity, Self-control, and Food Selection in Overweight Adults', 'orgStudyIdInfo': {'id': 'Overweight'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active tDCS over the dorsolateral prefrontal cortex (DLPFC)', 'description': 'In this group, participants will receive active 2 milliampere (mA) tdcs over the DLPFC (anode on F3 and cathode onF4) for 20 minutes.', 'interventionNames': ['Device: tDCS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active tDCS over the ventromedial prefrontal cortex (VMPFC)', 'description': 'In this group, participants will receive active 2 mA tdcs over the VMPFC (anode on Fpz and cathode on Cz) for 20 minutes.', 'interventionNames': ['Device: tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS Stimulation', '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.', 'interventionNames': ['Device: Sham tDCS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic supplementation', 'description': 'In this group, participants will consume 2 probiotic supplements (The synbiotics family) daily, for one month.', 'interventionNames': ['Drug: Probiotic Blend Capsule']}], 'interventions': [{'name': 'Probiotic Blend Capsule', 'type': 'DRUG', '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).', 'armGroupLabels': ['Probiotic supplementation']}, {'name': 'tDCS', 'type': 'DEVICE', '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.', 'armGroupLabels': ['Active tDCS over the dorsolateral prefrontal cortex (DLPFC)', 'Active tDCS over the ventromedial prefrontal cortex (VMPFC)']}, {'name': 'Sham tDCS', 'type': 'DEVICE', '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.', 'armGroupLabels': ['Sham tDCS Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1969713663', 'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Reza Kazemi, PHD', 'role': 'CONTACT', 'email': 'rezakazemi@ut.ac.ir', 'phone': '009802184012121'}, {'name': 'Sara Derafsheh, MSC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atieh neuroscience center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Abed Hadipour Lakmehsari, PhD', 'role': 'CONTACT', 'email': 'ahadipourlakmehsari@unime.it', 'phone': '3883041384', 'phoneExt': '+39'}], 'overallOfficials': [{'name': 'Marzieh Heysiattalab, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Tabriz'}, {'name': 'Reza Kazemi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Tehran'}, {'name': 'Sara Derafsheh, MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tabriz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tehran', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Messina', 'class': 'OTHER'}, {'name': 'Tabriz University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'reza kazemi', 'investigatorAffiliation': 'University of Tehran'}}}}