Investigating the effects of brain stimulation and probiotics on food decision-making in overweight adults
Comparing the Effectiveness of Transcranial Direct Stimulation (tDCS) and Probiotic Supplementation on Risky Decision-making, Impulsivity, Self-control, and Food Selection in Overweight Adults
This study is testing whether brain stimulation and probiotics can help overweight adults make better food choices and control their eating habits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Tehran Academic / other |
| Locations | 1 site (Tehran) |
| Trial ID | NCT06035718 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the effectiveness of transcranial direct current stimulation (tDCS) and probiotic supplementation in improving decision-making related to food choices among overweight individuals. By examining the gut-brain-microbiome axis, the researchers hypothesize that both interventions can enhance self-control and reduce impulsive eating behaviors. Participants will receive either the probiotic blend, tDCS, or a sham treatment to assess the impact on their decision-making processes. The study focuses on individuals with a BMI over 25 and higher than normal fat levels.
Who should consider this trial
Good fit: Ideal candidates for this study are overweight adults with a BMI over 25 and elevated fat levels.
Not a fit: Patients who are pregnant, breastfeeding, or have certain chronic health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new strategies for improving self-control and decision-making in overweight individuals, potentially aiding in weight management.
How similar studies have performed: While the combination of tDCS and probiotics is a novel approach, there have been successful studies exploring the individual effects of these interventions on behavior and health.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tehran
- Atieh neuroscience center — Tehran, Iran, Islamic Republic of (Recruiting)
Study contacts
- Principal investigator: Sara Derafsheh, MSC — University of Tabriz
- Study coordinator: Abed Hadipour Lakmehsari, PhD
- Email: ahadipourlakmehsari@unime.it
- Phone: 3883041384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.