Binge Eating DisorderPhase 1Gut2BrainNCT06823557
Investigation of the Mechanisms of the Gut-brain Axis in Binge Eating and Obesity.
A Phase 1 study testing Psychobiotic treatment in people with Binge Eating Disorder and Obesity, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Binge Eating Disorder (BED) is a recently recognized eating disorder, characterized by recurrent episodes of overeating with a loss of control. Highly comorbid with obesity, BED is associated with poor outcomes in weight loss treatments and presents unique challenges due to its distinct neuro-psycho-biological… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Eating Disorder, Obesity
- What is being tested?
- Psychobiotic treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 sitePortugal
- Study dates
- Apr 2025to Mar 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Portuguese adults (25 with normal weight; 25 with obesity only (30 ≤ BMI < 40) and BED; 54 with BED)
- Residents in Portugal for the past 10 years
Who cannot join
- Significant weight loss (>5% of body weight) in the past 2 years
- Antibiotic use in the past 6 months
- History of surgery or medical/psychiatric diseases
- Pregnant or breastfeeding
- History of drug use or dependence
- Use of medications that impact weight
- Have metal implants or pacemakers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Center for Psychology at University of Porto
Porto, Paranhos, 4200-135
Center for Psychology at University of Porto, +351 220 400 617, cpup@fpce.up.pt
About this study
Official title: Gut2Brain: Investigation of the Mechanisms of the Gut-brain Axis in Binge Eating and Obesity
Binge Eating Disorder (BED) is a recently recognized eating disorder, characterized by recurrent episodes of overeating with a loss of control. Highly comorbid with obesity, BED is associated with poor outcomes in weight loss treatments and presents unique challenges due to its distinct neuro-psycho-biological mechanisms, which remain poorly understood. The Microbiota-Gut-Brain Axis (MGBA) is a bidirectional communication system linking the gut microbiota with the central nervous system, that plays a critical role in regulating appetite, mood, and eating behavior. Dysregulations in MGBA may contribute to the development and maintenance of BED, offering a novel framework for understanding its complex mechanisms and identifying new therapeutic targets. Psychobiotics -pre-, pro-, or symbiotics that modulate the microbiota- emerge as a promising treatment strategy to address BED symptoms by influencing MGBA activity.
The goal of this randomized clinical trial (RCT) is to investigate the role of psychobiotics in modulating the gut-brain axis and improving binge eating in adults, with a particular focus on evaluating these effects independently of obesity status. This project stands out for its comprehensive approach to understanding BED, integrating psychological, neurofunctional, hormonal, and microbiota factors that contribute to this complex disorder.
Read more
The main questions it aims to answer are:
- What specific alterations in the MGBA pathways are associated with BED?
- Can psychobiotic supplementation effectively reverse microbiota alterations and modulate MGBA activity, ultimately improving BED symptoms? Researchers will compare participants receiving psychobiotics to those receiving a look-alike substance that contains no drug (a placebo) to evaluate whether psychobiotics impact endocrine hormones, neurofunction, psychological and behavioral factors related to eating regulation, and BED symptoms.
Participants will:
- Undergo an assessment protocol that includes microbiota sampling, blood tests for hormone analysis, neurofunctional evaluations, and psychological/behavioral assessments before and after the psychobiotics/ placebo intervention.
- Take psychobiotics or a placebo daily for 12 weeks and receive well-being monitoring
- Participate in follow-up visits three months after the intervention to monitor changes in BED symptoms and related parameters.
Read the detailed description
This research project aims to investigate the role of psychobiotics in reversing MGBA alterations specific to BED. Therefore, a two-arm Randomized Clinical Trial (RCT) will be conducted. Participants will include individuals with BED and obesity, individuals with obesity only, and individuals with normal weight that will be randomly assigned to one of two groups:
- an intervention group receiving psychobiotic supplementation ii) a control group receiving placebo supplementation. The sample size was computed considering the sample needed for 3 groups comparison in the RCT. G Power was used for (Mixed) ANOVAs considering f = 0.25, power = 90%, α = 0.05, and corr = 0.5., and 15% dropout.
At both the beginning and end of the trial, participants will undergo an assessment protocol.
Assessment protocol:
Participants will be invited to visit Braga Hospital where the assessment will take place for a scheduled appointment to undergo the assessment protocol for approximately 2 hours. The first step will involve the assessment of appetitive hormones through blood samples collected at three time points. The first blood sample (0 minutes) will be taken after a 12-hour overnight fast. Participants will consume 600 mL of a standardized liquid test meal, and additional blood draws will occur 10 and 30 minutes after the meal.
Between the second and third blood samples collected, participants will respond with some self-report measures. Specifically, self-report measures will assess socio-demographic data (age, sex, gender, education levels, marital status, and weight history) and psychological aspects: 1) emotional regulation and impulse control, distress tolerance, and positive and negative affects; 2) eating behavior, assessing eating expectancy, emotional eating, compulsive eating, and restraint eating. Then participants will do resting-state functional magnetic resonance imaging (rs-FMRI) performed to evaluate resting-state network connectivity.
Stool samples will be collected using a kit that includes all the necessary tools for proper sample collection and preparation for microbiota analysis.
The psychobiotic and the placebo package and instructions will be delivered during this scheduled appointment in Braga Hospital. All participants will be contacted weekly during the 12-week trial to ensure/increase adherence to the guidelines of prebiotic/placebo intervention.
Statistical Analyses:
Overall, multivariate analysis of variance (MANOVA) and/or general linear models (GLM) with mixed-model repeated measures will be used to examine group differences related to MGBA mechanisms, as well as significant main effects and interaction effects between baseline (T0) and the end of the RCT (T1). Structural equation modeling (SEM) will be employed to evaluate MGBA mechanisms as mediators of the changes observed between T0 and T1.
- Conditions
- Binge Eating Disorder, Obesity
- Being tested
- Psychobiotic treatment, Placebo treatment
- Keywords
- psychobiotic treatment, Study of neuro-psycho-biological mechanisms, Microbiota-Gut-Brain Axis (MGBA), Obesity, Binge eating disorder
- Medical subject headings
- Binge-Eating Disorder, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychobiotic treatmentDietary supplement
Also called Prebiotic, Inulin
The dietary supplementation will follow established guidelines, recommending an intake of 16 g of prebiotic per day, distributed across three meals, for a duration of 12 weeks.
Placebo treatmentOther
Also called Maltodextrin (Placebo)
The control group will receive identical packaging that matches the experimental treatment in taste and appearance and will follow the same guidelines for consuming the placebo. For ethical reasons, after the end of the RCT, the control group will be given the option to receive the same prebiotic supplement.
| Study group | Role | What they receive |
|---|---|---|
| Psychobiotic group | Experimental | An intervention group receiving a psychobiotic-a native inulin prebiotic. Native inulin extracted from chicory roots was selected as the psychobiotic since it is a mixture of short inulin molecules, which are metabolized primarily in the proximal colon and are more rapidly fermented, with longer chain ones, which are fermented later and slower in the distal colon. The psychobiotic nature of Inulin has been suggested in recent literature. Receives: Dietary Supplement: Psychobiotic treatment |
| Control group | Placebo comparator | A control group receiving a taste/appearance-matched placebo- the maltodextrin. Maltodextrin is a carbohydrate consisting of short chains of glucose molecules. It is commonly used as a placebo in clinical trials, providing no significant health benefits or harm when consumed with moderation. Receives: Other: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiota outcomes - Gut-Bacteria Composition
Stool samples from each participant will be fermented by the prebiotic to allow direct comparison of individual alterations in vitro and in vivo of the microbiome. Changes in gut-bacteria composition and its adhesion into the mucus layer will be analyzed.
Measured: Change measures: baseline and end of treatment at 12 weeks
Gut Microbiota outcomes - Molecules released by the gut-bacteria
Stool samples from each participant will be fermented by the prebiotic to allow direct comparison of individual alterations in vitro and in vivo of the microbiome. Molecules released by the bacteria, including short-chain fatty acids (SCFA), lipopolysaccharides (LPS), gamma-aminobutyric acid (GABA), dopamine, and serotonin, which modify host metabolism and central regulation of appetite directly via vagal stimulation or indirectly through immune-neuroendocrine mechanisms, will be traced during fermentations.
Measured: Change measures: baseline and end of treatment at 12 weeks
Psycho-behavioral outcomes - Three Factor Eating Questionnaire-21
Three Factor Eating Questionnaire-21 (TFEQ-21): assesses psychopathology and behaviors related to eating disorders, generating 3 subscales: emotional eating; compulsive eating; restraint eating.
Measured: Change measures: baseline, end of treatment at 12 weeks and follow-up at 12 weeks post-treatment.
Psycho-behavioral outcomes - Eating Expectancy Inventory
- The Eating Expectancy Inventory (EEI): evaluates cognitive expectations regarding eating
Measured: Change measures: baseline, end of treatment at 12 weeks and follow-up at 12 weeks post-treatment.
Psycho-behavioral outcomes - Negative urgency subscale
Negative urgency subscale from the Urgency, Premeditation, Perseverance, and Sensation Seeking scales (UPPS): assesses the tendency to act rashly/impulsively when experiencing negative emotions.
Measured: Change measures: baseline, end of treatment at 12 weeks and follow-up at 12 weeks post-treatment.
Psycho-behavioral outcomes - Difficulties in Emotion Regulation Scale
Difficulties in Emotion Regulation Scale (DERS): self-report measure developed to assess difficulties in emotional dysregulation.
Measured: Change measures: baseline, end of treatment at 12 weeks and follow-up at 12 weeks post-treatment.
Psycho-behavioral outcomes - Distress Tolerance Scale
The Distress Tolerance Scale (DTS): scale that assesses ability to experience, tolerate, and function in a context of emotional distress
Measured: Change measures: baseline, end of treatment at 12 weeks and follow-up at 12 weeks post-treatment.
Neurofunctioning outcomes - Default mode network
Neurofunctioning will be assessed through rs-fMRI. Specifically, we aim to compare the resting-state networks (RSNs), such as the default mode network (DMN), the salience network (SN), the meso/paralimbic network (MPN), and the executive network (EN) across the three groups. The DMN is involved in self-referential processing, which includes monitoring the external environment as well as physical and emotional states.
Measured: Change measures: baseline and end of treatment at 12 weeks
Neurofunctioning outcomes - Salience network
Neurofunctioning will be assessed through rs-fMRI. Specifically, we aim to compare the resting-state networks (RSNs), such as the default mode network (DMN), the salience network (SN), the meso/paralimbic network (MPN), and the executive network (EN) across the three groups. The DMN is involved in self-referential processing, which includes monitoring the external environment as well as physical and emotional states. The SN is involved in detecting the salience of stimuli, integrating emotional arousal, food, and reward processing.
Measured: Change measures: baseline and end of treatment at 12 weeks
Neurofunctioning outcomes - Meso/Paralimbic network
Neurofunctioning will be assessed through rs-fMRI. Specifically, we aim to compare the resting-state networks (RSNs), such as the default mode network (DMN), the salience network (SN), the meso/paralimbic network (MPN), and the executive network (EN) across the three groups. The MPN is involved in processing emotional information and interoceptive awareness.
Measured: Change measures: baseline and end of treatment at 12 weeks
Neurofunctioning outcomes - Executive network
Neurofunctioning will be assessed through rs-fMRI. Specifically, we aim to compare the resting-state networks (RSNs), such as the default mode network (DMN), the salience network (SN), the meso/paralimbic network (MPN), and the executive network (EN) across the three groups. The EN is involved in cognitive control and inhibitory processes, such as the termination of food consumption
Measured: Change measures: baseline and end of treatment at 12 weeks
Appetitive hormones outcomes - Ghrelin
Assessment of appetitive hormones that modulate eating behavior:
- Ghrelin is an orexigenic hormone with stimulatory effects on appetite and food intake.
Measured: Change measures: baseline and end of treatment at 12 weeks
Appetitive hormones outcomes - Glucagon-Like Peptide 1
Assessment of appetitive hormones that modulate eating behavior:
- Glucagon-Like Peptide 1 (GLP-1) have an anorexigenic effect and are thought to contribute to impaired satiation and binge eating tendencies. GLP-1 has been the target of novel therapeutics for weight loss, but few studies have examined its impact on BED.
Measured: Change measures: baseline and end of treatment at 12 weeks
Appetitive hormones outcomes - Peptide YY
Assessment of appetitive hormones that modulate eating behavior:
- Peptide YY (PYY) have an anorexigenic effect and are thought to contribute to impaired satiation and binge eating tendencies.
Measured: Change measures: baseline and end of treatment at 12 weeks
Appetitive hormones outcomes - Leptin
Assessment of appetitive hormones that modulate eating behavior:
- Leptin acts as a regulatory signal reflecting the adipose tissue stores. Both insufficiency and resistance to its actions promote hunger and increased food intake. Leptin can decrease food reward and act in the central nervous system as regulators of energy homeostasis.
Measured: Change measures: baseline and end of treatment at 12 weeks
Appetitive hormones outcomes - Insulin
Assessment of appetitive hormones that modulate eating behavior:
Insulin can decrease food reward and act in the central nervous system as regulators of energy homeostasis.
Measured: Change measures: baseline and end of treatment at 12 weeks
Appetitive hormones outcomes - Cortisol
Assessment of appetitive hormones that modulate eating behavior:
- Cortisol is responsible for the stress response, acting on the hypothalamic-pituitary axis, and it is associated with increased eating
Measured: Change measures: baseline and end of treatment at 12 weeks
Secondary outcomes (1)
Eating Disorder Examination
Eating Disorder Examination (EDE): semi-structured clinical interview for the diagnosis of binge eating disorder
Measured: baseline moment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study startApr 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled trial (RCT) will compare three groups: a BED+obesity group, an obesity group (without BED), and a normal-weight group (without BED). Participants will be randomized and allocated into two arms in a double-blind, placebo-controlled design: an intervention group receiving a psychobiotic and a control group receiving a placebo matched in taste and appearance. Randomization will follow the CONSORT guidelines, utilizing a computer-generated sequence of random numbers in a 1:1 ratio. Groups will be matched based on BMI, age, and sex. Participants meeting the inclusion and exclusion criteria will undergo a semi-structured clinical interview to diagnose BED. They will also receive detailed information about the study and sign an informed consent form prior to participation. Assessments will take place at two time points: baseline (T0), before initiating the psychobiotic or placebo, and follow-up (T1), after completion of the assessment protocol.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minho, Braga Hospital
- Responsible party
- Principal investigator, Eva Conceição, Universidade do Porto
- Investigators
- Eva M. Conceição, Principal investigator, Center for Psychology at University of Porto (CPUP)Clarisse N. Salomé, Principal investigator, Center for Engineering Biological (CEB) at University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823557
- Sponsor's protocol ID
- UPorto_Gut2Brain
- Acronym
- Gut2Brain
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut2Brain: Investigation of the Mechanisms of the Gut-brain Axis in Binge Eating and Obesity
- ClinicalTrials.gov ID
- NCT06823557
- Acronym / sponsor ID
- Gut2Brain / UPorto_Gut2Brain
- Conditions
- Binge Eating Disorder, Obesity
- Keywords
- psychobiotic treatment, Study of neuro-psycho-biological mechanisms, Microbiota-Gut-Brain Axis (MGBA), Obesity, Binge eating disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- University of Minho, Braga Hospital
- Study start
- Apr 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Binge Eating Disorder (BED) is a recently recognized eating disorder, characterized by recurrent episodes of overeating with a loss of control. Highly comorbid with obesity, BED is associated with poor outcomes in weight loss treatments and presents unique challenges due to its distinct neuro-psycho-biological mechanisms, which remain poorly understood. The Microbiota-Gut-Brain Axis (MGBA) is a bidirectional communication system linking the gut microbiota with the central nervous system, that plays a critical role in regulating appetite, mood, and eating behavior. Dysregulations in MGBA may contribute to the development and maintenance of BED, offering a novel framework for understanding its complex mechanisms and identifying new therapeutic targets. Psychobiotics -pre-, pro-, or symbiotics that modulate the microbiota- emerge as a promising treatment strategy to address BED symptoms by influencing MGBA activity.
The goal of this randomized clinical trial (RCT) is to investigate the role of psychobiotics in modulating the gut-brain axis and improving binge eating in adults, with a particular focus on evaluating these effects independently of obesity status. This project stands out for its comprehensive approach to understanding BED, integrating psychological, neurofunctional, hormonal, and microbiota factors that contribute to this complex disorder.
The main questions it aims to answer are:
- What specific alterations in the MGBA pathways are associated with BED?
- Can psychobiotic supplementation effectively reverse microbiota alterations and modulate MGBA activity, ultimately improving BED symptoms? Researchers will compare participants receiving psychobiotics to those receiving a look-alike substance that contains no drug (a placebo) to evaluate whether psychobiotics impact endocrine hormones, neurofunction, psychological and behavioral factors related to eating regulation, and BED symptoms.
Participants will:
- Undergo an assessment protocol that includes microbiota sampling, blood tests for hormone analysis, neurofunctional evaluations, and psychological/behavioral assessments before and after the psychobiotics/ placebo intervention.
- Take psychobiotics or a placebo daily for 12 weeks and receive well-being monitoring
- Participate in follow-up visits three months after the intervention to monitor changes in BED symptoms and related parameters.
Detailed description
This research project aims to investigate the role of psychobiotics in reversing MGBA alterations specific to BED. Therefore, a two-arm Randomized Clinical Trial (RCT) will be conducted. Participants will include individuals with BED and obesity, individuals with obesity only, and individuals with normal weight that will be randomly assigned to one of two groups:
- an intervention group receiving psychobiotic supplementation ii) a control group receiving placebo supplementation. The sample size was computed considering the sample needed for 3 groups comparison in the RCT. G Power was used for (Mixed) ANOVAs considering f = 0.25, power = 90%, α = 0.05, and corr = 0.5., and 15% dropout.
At both the beginning and end of the trial, participants will undergo an assessment protocol.
Assessment protocol:
Participants will be invited to visit Braga Hospital where the assessment will take place for a scheduled appointment to undergo the assessment protocol for approximately 2 hours. The first step will involve the assessment of appetitive hormones through blood samples collected at three time points. The first blood sample (0 minutes) will be taken after a 12-hour overnight fast. Participants will consume 600 mL of a standardized liquid test meal, and additional blood draws will occur 10 and 30 minutes after the meal.
Between the second and third blood samples collected, participants will respond with some self-report measures. Specifically, self-report measures will assess socio-demographic data (age, sex, gender, education levels, marital status, and weight history) and psychological aspects: 1) emotional regulation and impulse control, distress tolerance, and positive and negative affects; 2) eating behavior, assessing eating expectancy, emotional eating, compulsive eating, and restraint eating. Then participants will do resting-state functional magnetic resonance imaging (rs-FMRI) performed to evaluate resting-state network connectivity.
Stool samples will be collected using a kit that includes all the necessary tools for proper sample collection and preparation for microbiota analysis.
The psychobiotic and the placebo package and instructions will be delivered during this scheduled appointment in Braga Hospital. All participants will be contacted weekly during the 12-week trial to ensure/increase adherence to the guidelines of prebiotic/placebo intervention.
Statistical Analyses:
Overall, multivariate analysis of variance (MANOVA) and/or general linear models (GLM) with mixed-model repeated measures will be used to examine group differences related to MGBA mechanisms, as well as significant main effects and interaction effects between baseline (T0) and the end of the RCT (T1). Structural equation modeling (SEM) will be employed to evaluate MGBA mechanisms as mediators of the changes observed between T0 and T1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This randomized controlled trial (RCT) will compare three groups: a BED+obesity group, an obesity group (without BED), and a normal-weight group (without BED). Participants will be randomized and allocated into two arms in a double-blind, placebo-controlled design: an intervention group receiving a psychobiotic and a control group receiving a placebo matched in taste and appearance. Randomization will follow the CONSORT guidelines, utilizing a computer-generated sequence of random numbers in a 1:1 ratio. Groups will be matched based on BMI, age, and sex. Participants meeting the inclusion and exclusion criteria will undergo a semi-structured clinical interview to diagnose BED. They will also receive detailed information about the study and sign an informed consent form prior to participation. Assessments will take place at two time points: baseline (T0), before initiating the psychobiotic or placebo, and follow-up (T1), after completion of the assessment protocol.
| Arm | Type | Receives |
|---|---|---|
| Psychobiotic group | Experimental | Dietary Supplement: Psychobiotic treatmentAn intervention group receiving a psychobiotic-a native inulin prebiotic. Native inulin extracted from chicory roots was selected as the psychobiotic since it is a mixture of short inulin molecules, which are metabolized primarily in the proximal colon and are more rapidly fermented, with longer chain ones, which are fermented later and slower in the distal colon. The psychobiotic nature of Inulin has been suggested in recent literature. |
| Control group | Placebo comparator | Other: Placebo treatmentA control group receiving a taste/appearance-matched placebo- the maltodextrin. Maltodextrin is a carbohydrate consisting of short chains of glucose molecules. It is commonly used as a placebo in clinical trials, providing no significant health benefits or harm when consumed with moderation. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Portuguese adults (25 with normal weight; 25 with obesity only (30 ≤ BMI < 40) and BED; 54 with BED)
- Residents in Portugal for the past 10 years
Key exclusion criteria (7 listed)
- Significant weight loss (>5% of body weight) in the past 2 years
- Antibiotic use in the past 6 months
- History of surgery or medical/psychiatric diseases
- Pregnant or breastfeeding
- History of drug use or dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychobiotic treatmentAlso: Prebiotic, InulinThe dietary supplementation will follow established guidelines, recommending an intake of 16 g of prebiotic per day, distributed across three meals, for a duration of 12 weeks. | Dietary supplement | Psychobiotic group |
| Placebo treatmentAlso: Maltodextrin (Placebo)The control group will receive identical packaging that matches the experimental treatment in taste and appearance and will follow the same guidelines for consuming the placebo. For ethical reasons, after the end of the RCT, the control group will be given the option to receive the same prebiotic supplement. | Other | Control group |
Primary outcome
Gut Microbiota outcomes - Gut-Bacteria Composition
Time frame: Change measures: baseline and end of treatment at 12 weeks
Stool samples from each participant will be fermented by the prebiotic to allow direct comparison of individual alterations in vitro and in vivo of the microbiome. Changes in gut-bacteria composition and its adhesion into the mucus layer will be analyzed.
Gut Microbiota outcomes - Molecules released by the gut-bacteria
Time frame: Change measures: baseline and end of treatment at 12 weeks
Stool samples from each participant will be fermented by the prebiotic to allow direct comparison of individual alterations in vitro and in vivo of the microbiome. Molecules released by the bacteria, including short-chain fatty acids (SCFA), lipopolysaccharides (LPS), gamma-aminobutyric acid (GABA), dopamine, and serotonin, which modify host metabolism and central regulation of appetite directly via vagal stimulation or indirectly through immune-neuroendocrine mechanisms, will be traced during fermentations.
Psycho-behavioral outcomes - Three Factor Eating Questionnaire-21
Time frame: Change measures: baseline, end of treatment at 12 weeks and follow-up at 12 weeks post-treatment.
Three Factor Eating Questionnaire-21 (TFEQ-21): assesses psychopathology and behaviors related to eating disorders, generating 3 subscales: emotional eating; compulsive eating; restraint eating.
Psycho-behavioral outcomes - Eating Expectancy Inventory
Time frame: Change measures: baseline, end of treatment at 12 weeks and follow-up at 12 weeks post-treatment.
- The Eating Expectancy Inventory (EEI): evaluates cognitive expectations regarding eating
Psycho-behavioral outcomes - Negative urgency subscale
Time frame: Change measures: baseline, end of treatment at 12 weeks and follow-up at 12 weeks post-treatment.
Negative urgency subscale from the Urgency, Premeditation, Perseverance, and Sensation Seeking scales (UPPS): assesses the tendency to act rashly/impulsively when experiencing negative emotions.
Psycho-behavioral outcomes - Difficulties in Emotion Regulation Scale
Time frame: Change measures: baseline, end of treatment at 12 weeks and follow-up at 12 weeks post-treatment.
Difficulties in Emotion Regulation Scale (DERS): self-report measure developed to assess difficulties in emotional dysregulation.
Psycho-behavioral outcomes - Distress Tolerance Scale
Time frame: Change measures: baseline, end of treatment at 12 weeks and follow-up at 12 weeks post-treatment.
The Distress Tolerance Scale (DTS): scale that assesses ability to experience, tolerate, and function in a context of emotional distress
Neurofunctioning outcomes - Default mode network
Time frame: Change measures: baseline and end of treatment at 12 weeks
Neurofunctioning will be assessed through rs-fMRI. Specifically, we aim to compare the resting-state networks (RSNs), such as the default mode network (DMN), the salience network (SN), the meso/paralimbic network (MPN), and the executive network (EN) across the three groups. The DMN is involved in self-referential processing, which includes monitoring the external environment as well as physical and emotional states.
Neurofunctioning outcomes - Salience network
Time frame: Change measures: baseline and end of treatment at 12 weeks
Neurofunctioning will be assessed through rs-fMRI. Specifically, we aim to compare the resting-state networks (RSNs), such as the default mode network (DMN), the salience network (SN), the meso/paralimbic network (MPN), and the executive network (EN) across the three groups. The DMN is involved in self-referential processing, which includes monitoring the external environment as well as physical and emotional states. The SN is involved in detecting the salience of stimuli, integrating emotional arousal, food, and reward processing.
Neurofunctioning outcomes - Meso/Paralimbic network
Time frame: Change measures: baseline and end of treatment at 12 weeks
Neurofunctioning will be assessed through rs-fMRI. Specifically, we aim to compare the resting-state networks (RSNs), such as the default mode network (DMN), the salience network (SN), the meso/paralimbic network (MPN), and the executive network (EN) across the three groups. The MPN is involved in processing emotional information and interoceptive awareness.
Neurofunctioning outcomes - Executive network
Time frame: Change measures: baseline and end of treatment at 12 weeks
Neurofunctioning will be assessed through rs-fMRI. Specifically, we aim to compare the resting-state networks (RSNs), such as the default mode network (DMN), the salience network (SN), the meso/paralimbic network (MPN), and the executive network (EN) across the three groups. The EN is involved in cognitive control and inhibitory processes, such as the termination of food consumption
Appetitive hormones outcomes - Ghrelin
Time frame: Change measures: baseline and end of treatment at 12 weeks
Assessment of appetitive hormones that modulate eating behavior: * Ghrelin is an orexigenic hormone with stimulatory effects on appetite and food intake.
Appetitive hormones outcomes - Glucagon-Like Peptide 1
Time frame: Change measures: baseline and end of treatment at 12 weeks
Assessment of appetitive hormones that modulate eating behavior: * Glucagon-Like Peptide 1 (GLP-1) have an anorexigenic effect and are thought to contribute to impaired satiation and binge eating tendencies. GLP-1 has been the target of novel therapeutics for weight loss, but few studies have examined its impact on BED.
Appetitive hormones outcomes - Peptide YY
Time frame: Change measures: baseline and end of treatment at 12 weeks
Assessment of appetitive hormones that modulate eating behavior: - Peptide YY (PYY) have an anorexigenic effect and are thought to contribute to impaired satiation and binge eating tendencies.
Appetitive hormones outcomes - Leptin
Time frame: Change measures: baseline and end of treatment at 12 weeks
Assessment of appetitive hormones that modulate eating behavior: * Leptin acts as a regulatory signal reflecting the adipose tissue stores. Both insufficiency and resistance to its actions promote hunger and increased food intake. Leptin can decrease food reward and act in the central nervous system as regulators of energy homeostasis.
Appetitive hormones outcomes - Insulin
Time frame: Change measures: baseline and end of treatment at 12 weeks
Assessment of appetitive hormones that modulate eating behavior: Insulin can decrease food reward and act in the central nervous system as regulators of energy homeostasis.
Appetitive hormones outcomes - Cortisol
Time frame: Change measures: baseline and end of treatment at 12 weeks
Assessment of appetitive hormones that modulate eating behavior: - Cortisol is responsible for the stress response, acting on the hypothalamic-pituitary axis, and it is associated with increased eating
1 secondary outcome
Eating Disorder Examination
Time frame: baseline moment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva M. Conceição principal investigator
Center for Psychology at University of Porto (CPUP)
Clarisse N. Salomé principal investigator
Center for Engineering Biological (CEB) at University of Minho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psychobiotic treatment in people with Binge Eating Disorder and Obesity, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva M. Conceição (+351 917 853 236, econceicao@fpce.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiota outcomes - Gut-Bacteria Composition (time frame: Change measures: baseline and end of treatment at 12 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.