The Brain, the Bug, and the Binge: the Interplay Between Binge Drinking, Gut Microbiota, and Brain Functioning

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-23
SponsorUniversity of Minho

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

College students whose native language is Portuguese;

Age 18-23 years;

Binge Drinkers: report (i) drinking 4 (for women)/5 (for men) or more drinks on one occasion at least once a month, (ii) drinking at a speed of at least two drinks per hour during these episodes (which brings blood alcohol concentration to 0.08 g/dL or above), and (iii) having an AUDIT score < 20.

Non/Low-Drinkers: report (i) never drinking 4/5 or more drinks on one occasion and (ii) having an AUDIT score ≤ 4.

Disqualifiers

Use of illicit drugs as determined by the Drug Use Disorders Identification Test (DUDIT);

Alcohol abuse (i.e., AUDIT ≥ 20);

Personal history of psychopathological disorders (according to DSM-V criteria);

History of traumatic brain injury or neurological disorder;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

82 Participants
are divided into 3 treatment groups
Group A: Binge Drinkers with Inulin InterventionActive comparator 1 intervention
Group B: Binge Drinkers with Maltodextrin InterventionPlacebo comparator 1 intervention
Group C: Non/Low-DrinkersNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline (pre-intervention)
2

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.

Time frame
Immediately post-intervention.
3

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.

Time frame
At baseline (pre-intervention)
4

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.

Time frame
Immediately post-intervention

Secondary outcomes

1

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.

Time frame
Immediately post-intervention
2

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.

Time frame
3 months post-intervention
3

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).

Time frame
Immediately post-intervention
4

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).

Time frame
3 months post-intervention

Other outcomes

Sponsors and contacts

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University of Minho

Lead sponsor

Foundation for Science and Technology, Portugal

Collaborator