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| ID | Type | Description | Link |
|---|---|---|---|
| PTDC/PSI-ESP/1243/2021 | Other Grant/Funding Number | Portuguese Foundation for Science and Technology |
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| Name | Class |
|---|---|
| Foundation for Science and Technology, Portugal | OTHER |
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Adolescence and youth are periods of significant maturational changes which seems to involve greater susceptibility to disruptive events in the brain such as binge drinking (BD). This prevalent pattern of consumption -characterized by repeated alcohol intoxications- is of special concern, as it has been associated with major neurocognitive impairments in the young brain.
Recent studies indicate that alcohol may disrupt the gut microbiota (GM) and that these disruptions may lead to impairments in brain and behavior. Also, interventions with psychobiotics have been shown to result in reductions in alcohol-induced damage and in improvements on cognitive and brain functioning.
Thus, the present proposal will explore the effects of BD on GM. Additionally, a GM intervention with psychobiotics both in-vivo and in-vitro, will determine whether improvements in GM composition/function may lead to reductions of alcohol-induced brain damage in BD-population, a barely unexplored research field with major clinical applications.
The present study protocol aims to determine the interaction between alcohol consumption, brain function and gut microbiota through several levels of analysis, including techniques to measure brain activity (i.e., magnetic resonance imaging), paradigms to measure cognitive performance, collection of stool and blood samples, and questionnaires. Additionally, this study will investigate the relationship between alcohol, brain activity and gut microbiota and how this can be modified through our diet. The sample will be composed by a cohort of young college students (18-23 years) from the University of Minho (UM; Braga, Portugal) selected according to their drinking patterns. Eighty-two participants will be recruited from UM: 36 non/low-drinkers and 46 binge drinkers (BDs) matched for age and gender. Recruitment will be carried out through an online survey broadcasted using the institutional email. This survey will include a simple sociodemographic section and items regarding the use of alcohol (Alcohol Use Disorder Identification Test - AUDIT, frequency of alcohol consumption, number of drinks consumed on each day of the past week, speed of drinking, etc.). After sample selection, participants will be submitted to the following steps: (1) clinical interview - addresses questions relating to psychological, medical, personal and family history, including questions related to history of alcohol and drug use and some specific questionnaires relating to substance use, as well as those related to physical and psychological symptoms, and personality; (2) neuroimaging assessment - will consist of a structural and functional magnetic resonance imaging (fMRI) at the Hospital de Guimarães (Portugal), while performing different cognitive tasks; (3) evaluation of some microorganisms residing in the gut and certain inflammatory markers - each participant will be asked to collect stool and blood samples; (4) evaluation of the potential of an intervention with psychobiotics.
Thus, this protocol involves the following phases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Binge Drinkers with Inulin Intervention | Active Comparator | 23 binge drinkers (~50 % male and ~50 % female) will be given a daily dose of inulin. |
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| Binge Drinkers with Maltodextrin Intervention | Placebo Comparator | 23 binge drinkers (~50 % male and ~50 % female) will be given a daily dose of maltodextrin. |
|
| Non/Low-Drinkers | No Intervention | 36 non/low-drinkers will not be given any dietary fiber. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inulin Intervention | Dietary Supplement | For 6 weeks, 23 binge drinkers will be given a daily dose (divided into three times a day) of 15g of a dietary fiber with benefits for intestinal bacteria (inulin). |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal Microbiota - Species Richness | Faecal samples will be collected from all participants for microbiota α-diversity analysis by 16S rRNA metagenomics (Illumina sequencing). The Chao1 Index will be used as an estimator of nonparametric microbial species richness in each sample. | At baseline (pre-intervention) |
| Fecal Microbiota - Species Richness | Faecal samples will be collected only from binge drinkers subjected to the intervention for microbiota α-diversity analysis by 16S rRNA metagenomics (Illumina sequencing). The Chao1 Index will be used as an estimator of nonparametric microbial species richness in each sample. | Immediately post-intervention. |
| Fecal Microbiota - Species Diversity | Faecal samples will be collected from all participants for microbiota α-diversity analysis by 16S rRNA metagenomics (Illumina sequencing). The Shannon Diversity Index (metric combining richness and evenness, with equal weighting given to abundant and rare species) and the Simpson Diversity Index (metric of richness and evenness, in which more weighting is given to abundant species) will be used. | At baseline (pre-intervention) |
| Fecal Microbiota - Species Diversity | Faecal samples will be collected only from binge drinkers subjected to the intervention for microbiota α-diversity analysis by 16S rRNA metagenomics (Illumina sequencing). The Shannon Diversity Index (metric combining richness and evenness, with equal weighting given to abundant and rare species) and the Simpson Diversity Index (metric of richness and evenness, in which more weighting is given to abundant species) will be used. | Immediately post-intervention |
| Fecal Microbiota - Quantification of SCFAs levels | The concentration of short-chain fatty acids (SCFAs) present in each collected faecal sample shall be quantified by High Performance Liquid Chromatography (HPLC). |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Consumption - Drinking pattern | The AUDIT will be administered to characterize the drinking pattern of the participants. AUDIT scores ≤ 4 reveal low risk of alcohol use; scores between 5 and 20 represent excessive alcohol consumption; and scores ≥ 20 indicate very high risk for alcohol dependence and warrant further diagnostic evaluation for alcohol dependence. | Immediately post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo G. López-Caneda, PhD | Contact | (+351) 253 604 223 | eduardo.lopez@psi.uminho.pt | |
| Clarisse N. Gonçalves, PhD | Contact | clarissenobre@deb.uminho.pt |
| Name | Affiliation | Role |
|---|---|---|
| Eduardo G. López-Caneda, PhD | Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho, Portugal. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychological Neuroscience Laboratory, Psychology Research Center, University of Minho | Recruiting | Braga | Gualtar, Braga | 4710-057 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36739238 | Background | Carbia C, Bastiaanssen TFS, Iannone LF, Garcia-Cabrerizo R, Boscaini S, Berding K, Strain CR, Clarke G, Stanton C, Dinan TG, Cryan JF. The Microbiome-Gut-Brain axis regulates social cognition & craving in young binge drinkers. EBioMedicine. 2023 Mar;89:104442. doi: 10.1016/j.ebiom.2023.104442. Epub 2023 Feb 2. | |
| 31487578 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 28, 2024 | Oct 28, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D063425 | Binge Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000428 | Alcohol Drinking |
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Binge Drinkers will be randomly distributed for one of two groups: 23 subjects with inulin intervention and 23 subjects with maltodextrin intervention (~50 % male and ~50 % female in each group).
There will also be a non-interventional control group consisting of 36 non/low-drinkers.
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| Maltodextrin Intervention | Dietary Supplement | For 6 weeks, 23 binge drinkers will be given a daily dose (divided into three times a day) of 15g of dietary fiber with no specific benefits for the intestinal microbiome (maltodextrin). |
|
| At baseline (pre-intervention) |
| Fecal Microbiota - Quantification of SCFAs levels | The concentration of SCFAs present in each collected faecal sample shall be quantified by HPLC. | Immediately post-intervention. |
| Alcohol Consumption - Drinking pattern | The AUDIT will be administered to characterize the drinking pattern of the participants. AUDIT scores ≤ 4 reveal low risk of alcohol use; scores between 5 and 20 represent excessive alcohol consumption; and scores ≥ 20 indicate very high risk for alcohol dependence and warrant further diagnostic evaluation for alcohol dependence. | 3 months post-intervention |
| Alcohol Craving - Short-term acute craving | Short-term alcohol craving levels will be assessed using the ACQ-SF-R at the present moment. Total minimum score: 1 (low level of alcohol craving); Total maximum score: 7 (high level of alcohol craving). | Immediately post-intervention |
| Alcohol Craving - Short-term acute craving | Short-term alcohol craving levels will be assessed using the ACQ-SF-R at the present moment. Total minimum score: 1 (low level of alcohol craving); Total maximum score: 7 (high level of alcohol craving). | 3 months post-intervention |
| Neuropsychological Evaluation - Memory | The Delayed Matching to Sample (DMS) from Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used to assess both simultaneous visual matching ability and short-term visual recognition memory, for non-verbalisable patterns. | At baseline (pre-intervention) |
| Neuropsychological Evaluation - Memory | The Delayed Matching to Sample (DMS) from Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used to assess both simultaneous visual matching ability and short-term visual recognition memory, for non-verbalisable patterns. | Immediately post-intervention |
| Neuropsychological Evaluation - Emotion and Social Cognition | The Emotion Recognition Task (ERT) from CANTAB will measure the ability to identify six basic emotions (sadness, happiness, fear, anger, disgust, and surprise) in facial expressions along a continuum of expression magnitude. | At baseline (pre-intervention) |
| Neuropsychological Evaluation - Emotion and Social Cognition | The Emotion Recognition Task (ERT) from CANTAB will measure the ability to identify six basic emotions (sadness, happiness, fear, anger, disgust, and surprise) in facial expressions along a continuum of expression magnitude. | Immediately post-intervention |
| Neuropsychological Evaluation - Executive Function | The performance of the cognitive domain comprising high-level thinking and decision-making will be assessed through CANTAB, namely the Cambridge Gambling Task (CGT, to assess decision-making and risk behaviour outside a learning context), Intra-Extra Dimensional Set Shift (IED, to assess cognitive flexibility), Spatial Working Memory (SWM, to identify working memory strategies and errors) and Stop Signal Task (SST, to measure response inhibition/impulse control). | At baseline (pre-intervention) |
| Neuropsychological Evaluation - Executive Function | The performance of the cognitive domain comprising high-level thinking and decision-making will be assessed through CANTAB, namely the Cambridge Gambling Task (CGT, to assess decision-making and risk behaviour outside a learning context), Intra-Extra Dimensional Set Shift (IED, to assess cognitive flexibility), Spatial Working Memory (SWM, to identify working memory strategies and errors) and Stop Signal Task (SST, to measure response inhibition/impulse control). | Immediately post-intervention |
| Alcohol Cue Reactivity - Emotional measures | The reactivity to alcoholic cues will be assessed using the Alcohol Cue Reactivity (ACR) task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set. The emotional responses for each image in terms of valence and arousal task, will be registered using the Self-Assessment Manikin (valence: from 1 = "very unpleasant" to 9 ="very pleasant"; arousal: from 1 = "not arousing" to 9 = "highly arousing") during the ACR task. | At baseline (pre-intervention) |
| Alcohol Cue Reactivity - Emotional measures | The reactivity to alcoholic cues will be assessed using the ACR task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set. The emotional responses for each image in terms of valence and arousal task, will be registered using the Self-Assessment Manikin (valence: from 1 = "very unpleasant" to 9 ="very pleasant"; arousal: from 1 = "not arousing" to 9 = "highly arousing") during the ACR task. | Immediately post-intervention. |
| Memory Inhibition Performance | Memory Inhibition (MI), specifically alcohol-related MI, will be assessed using the Think/No-Think Alcohol (TNTA) task. Percentage of correct responses (for Think, No-Think and Baseline items) in the TNTA task will be computed according to the following formula: ((number of correctly recalled items)/(number of previously learned items))×100. Correct responses correspond to the items learned during the learning phase and correctly recalled during the memory test phase. | At baseline (pre-intervention) |
| Memory Inhibition Performance | MI, specifically alcohol-related MI, will be assessed using the TNTA task. Percentage of correct responses (for Think, No-Think and Baseline items) in the TNTA task will be computed according to the following formula: ((number of correctly recalled items)/(number of previously learned items))×100. Correct responses correspond to the items learned during the learning phase and correctly recalled during the memory test phase. | Immediately post-intervention. |
| Ability of Emotional Recognition | Emotional recognition capacity will be assessed through the Emotion Discrimination (ED) task. ED assesses the brain's preconscious and conscious responses to emotional faces. The complete task includes a total of 120 images of human faces (60 men and 60 women), showing the main negative emotions: angry, sadness and fear. | At baseline (pre-intervention) |
| Ability of Emotional Recognition | Emotional recognition capacity will be assessed through the ED task. ED assesses the brain's preconscious and conscious responses to emotional faces. The complete task includes a total of 120 images of human faces (60 men and 60 women), showing the main negative emotions: angry, sadness and fear. | Immediately post-intervention. |
| Blood samples - Presence of Inflammatory Markers | Blood samples will be collected from all participants. The presence and abundance of the following cytokines will be analyzed: Tumour Necrosis Factor α (TNF-α) and Interleukins (IL-1β, IL-6, IL-10). | At baseline (pre-intervention) |
| Blood samples - Presence of Inflammatory Markers | Blood samples will be collected only from binge drinkers subjected to the intervention. The presence and abundance of the following cytokines will be analyzed: Tumour Necrosis Factor α (TNF-α) and Interleukins (IL-1β, IL-6, IL-10). | Immediately post-intervention. |
| Neurofunctional level - Think/No-Think Alcohol (TNTA) Task | The TNTA task assesses memory inhibition mechanisms in alcohol-related contexts. It involves three phases - Learning, Think/No-Think and Memory Test - during which participants memorise pairs of images (human faces with a neutral expression and alcoholic/non-alcoholic beverages) and are subsequently instructed to actively recall or suppress these associations. | At baseline (pre-intervention) |
| Neurofunctional level - Think/No-Think Alcohol (TNTA) Task | The TNTA task assesses memory inhibition mechanisms in alcohol-related contexts. It involves three phases - Learning, Think/No-Think and Memory Test - during which participants memorise pairs of images (human faces with a neutral expression and alcoholic/non-alcoholic beverages) and are subsequently instructed to actively recall or suppress these associations. | Immediately post-intervention |
| Neurofunctional level - Emotional Face Matching (EFM) Task | The EFM task assesses emotional recognition ability and pre-conscious and conscious neural responses to emotional faces and geometric forms. During each trial, participants view three emotional faces or shapes (one on top and two on the bottom, in a triangular configuration) and are instructed to identify the emotion/shape at the top of the screen and match it with the corresponding one at the bottom using handheld response buttons. | At baseline (pre-intervention) |
| Neurofunctional level - Emotional Face Matching (EFM) Task | The EFM task assesses emotional recognition ability and pre-conscious and conscious neural responses to emotional faces and geometric forms. During each trial, participants view three emotional faces or shapes (one on top and two on the bottom, in a triangular configuration) and are instructed to identify the emotion/shape at the top of the screen and match it with the corresponding one at the bottom using handheld response buttons. | Immediately post-intervention |
| Neurofunctional level - Alcohol Cue Reactivity (ACR) Task | The ACR task assesses the emotional and attentional response to alcoholic stimuli. Participants are shown images of alcoholic and non-alcoholic drinks, interspersed with oddball blocks containing neutral objects, to which they must respond by pressing a button. After viewing all images, participants are asked to rate their emotional responses to the alcoholic or non-alcoholic beverage images in terms of valence, arousal, and desire. | At baseline (pre-intervention) |
| Neurofunctional level - Alcohol Cue Reactivity (ACR) Task | The ACR task assesses the emotional and attentional response to alcoholic stimuli. Participants are shown images of alcoholic and non-alcoholic drinks, interspersed with oddball blocks containing neutral objects, to which they must respond by pressing a button. After viewing all images, participants are asked to rate their emotional responses to the alcoholic or non-alcoholic beverage images in terms of valence, arousal, and desire. | Immediately post-intervention |
| Sousa SS, Sampaio A, Marques P, Lopez-Caneda E, Goncalves OF, Crego A. Functional and structural connectivity of the executive control network in college binge drinkers. Addict Behav. 2019 Dec;99:106009. doi: 10.1016/j.addbeh.2019.05.033. Epub 2019 Jun 3. |
| 33418172 | Background | Almeida-Antunes N, Crego A, Carbia C, Sousa SS, Rodrigues R, Sampaio A, Lopez-Caneda E. Electroencephalographic signatures of the binge drinking pattern during adolescence and young adulthood: A PRISMA-driven systematic review. Neuroimage Clin. 2021;29:102537. doi: 10.1016/j.nicl.2020.102537. Epub 2020 Dec 17. |
| 24881329 | Background | White A, Hingson R. The burden of alcohol use: excessive alcohol consumption and related consequences among college students. Alcohol Res. 2013;35(2):201-18. doi: 10.35946/arcr.v35.2.11. |
| 33288871 | Background | Carbia C, Lannoy S, Maurage P, Lopez-Caneda E, O'Riordan KJ, Dinan TG, Cryan JF. A biological framework for emotional dysregulation in alcohol misuse: from gut to brain. Mol Psychiatry. 2021 Apr;26(4):1098-1118. doi: 10.1038/s41380-020-00970-6. Epub 2020 Dec 7. |
| 22968153 | Background | Cryan JF, Dinan TG. Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour. Nat Rev Neurosci. 2012 Oct;13(10):701-12. doi: 10.1038/nrn3346. Epub 2012 Sep 12. |
| 31753762 | Background | Cryan JF, O'Riordan KJ, Sandhu K, Peterson V, Dinan TG. The gut microbiome in neurological disorders. Lancet Neurol. 2020 Feb;19(2):179-194. doi: 10.1016/S1474-4422(19)30356-4. Epub 2019 Nov 18. |
| 25288760 | Background | Leclercq S, Matamoros S, Cani PD, Neyrinck AM, Jamar F, Starkel P, Windey K, Tremaroli V, Backhed F, Verbeke K, de Timary P, Delzenne NM. Intestinal permeability, gut-bacterial dysbiosis, and behavioral markers of alcohol-dependence severity. Proc Natl Acad Sci U S A. 2014 Oct 21;111(42):E4485-93. doi: 10.1073/pnas.1415174111. Epub 2014 Oct 6. |
| 28244981 | Background | Leclercq S, de Timary P, Delzenne NM, Starkel P. The link between inflammation, bugs, the intestine and the brain in alcohol dependence. Transl Psychiatry. 2017 Feb 28;7(2):e1048. doi: 10.1038/tp.2017.15. |
| 30172845 | Background | Jadhav KS, Peterson VL, Halfon O, Ahern G, Fouhy F, Stanton C, Dinan TG, Cryan JF, Boutrel B. Gut microbiome correlates with altered striatal dopamine receptor expression in a model of compulsive alcohol seeking. Neuropharmacology. 2018 Oct;141:249-259. doi: 10.1016/j.neuropharm.2018.08.026. Epub 2018 Aug 31. |
| 30031625 | Background | Leclercq S, Starkel P, Delzenne NM, de Timary P. The gut microbiota: A new target in the management of alcohol dependence? Alcohol. 2019 Feb;74:105-111. doi: 10.1016/j.alcohol.2018.03.005. Epub 2018 Mar 20. |
| 31328014 | Background | Lannoy S, Billieux J, Dormal V, Maurage P. Behavioral and Cerebral Impairments Associated with Binge Drinking in Youth: A Critical Review. Psychol Belg. 2019 Mar 29;59(1):116-155. doi: 10.5334/pb.476. |
| 30375668 | Background | Lopez-Caneda E, Crego A, Campos AD, Gonzalez-Villar A, Sampaio A. The Think/No-Think Alcohol Task: A New Paradigm for Assessing Memory Suppression in Alcohol-Related Contexts. Alcohol Clin Exp Res. 2019 Jan;43(1):36-47. doi: 10.1111/acer.13916. Epub 2018 Nov 25. |
| 40908013 | Derived | Prata-Martins D, Nobre C, Almeida-Antunes N, Azevedo P, Sousa SS, Crego A, Cryan J, Sampaio A, Carbia C, Lopez-Caneda E. Assessing the impact of binge drinking and a prebiotic intervention on the gut-brain axis in young adults: protocol for a randomised controlled trial. BMJ Open. 2025 Sep 4;15(9):e095932. doi: 10.1136/bmjopen-2024-095932. |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |