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Impact of Omega 3 in Alcohol Use Disorder

Impact of Omega-3 Polyunsaturated Fatty Acids on Emotional, Cognitive and Biological Alterations in Alcohol Use Disorder

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05899660
Acronym
W3-AUD
Enrollment
100
Registered
2023-06-12
Start date
2023-06-19
Completion date
2027-12-31
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Severe

Keywords

gut microbiota, Omega 3, metabolomics, Depression, Anxiety, Alcohol craving, Sociability, Cognition, Inflammation, Brain imaging

Brief summary

The goal of this clinical trial is to investigate the biological pathways underlying the beneficial effect of omega-3 polyunsaturated fatty acids (n-3 PUFA) on mental health in patients with alcohol use disorder. The main questions this study aims to answer are: * Can n-3 PUFA improve mood disorders (depression, anxiety), craving for alcohol, cognitive impairments and sociability disorders ? * Are the beneficial effects of n-3 PUFAs due to a modification of the gut microbiota and/or the inflammatory status? Participants will : * take a supplementation of omega-3 or placebo during 3 months * do a brain MRI * be interviewed for a dietary anamnesis * provide blood, stool and saliva samples * perform psychological tests and neuropsychological tasks Researchers will compare active comparator (omega-3) with placebo comparator (olive oil) to see if omega-3 can have a beneficial effect on AUD patients.

Detailed description

Alcohol use disorder (AUD) is the most widespread addiction in Belgium and Europe and constitutes a major public health problem with important physical, psychological and economic consequences for the consumer and his family, friends, co-workers. For several years, the intestinal microbiota has been increasingly studied because it seems to play an indispensable role in the proper functioning of the body. Indeed, it is involved in the regulation of the immune system, metabolic reactions and the nervous system and therefore influences behaviour. The composition of the microbiota is specific to everyone and is influenced by many factors, such as diet, medication and lifestyle. In the case of AUD, numerous studies have shown that alcohol and its metabolites alter the intestinal microbiota, leading to an increase in inflammation and changes in behaviour. Nutritional intervention is an encouraging and innovative approach to alcohol addiction therapy. The main aim of this research is to see how a nutritional intervention could improve mood, cognition and social behaviour in AUD patients. The interest will therefore focus on Omega-3. These polyunsaturated fatty acids are found in the diet, mainly in fish oils, and are constituents of the body's cell membranes and perform many physiological functions. They also play an important role in the regulation of inflammation. Studies have shown that Omega-3 supplementation can reduce symptoms of depression and have beneficial effects in autism spectrum disorders, schizophrenia, bipolar disorders and neurodegenerative diseases. They have therefore been widely studied, but their role in social interactions, which is an important factor in many mental illnesses including AUD, has not yet been studied. The investigators will conduct a randomised, placebo-controlled, double-blind study, testing the impact of Omega-3 supplementation on AUD patients undergoing a detoxification program at the Saint-Luc University Hospital, Brussels, Belgium. 100 patients will be enrolled and the Omega 3/placebo supplementation will last for 3 months. The patients will be tested 3 times: T1 (2nd day of withdrawal), T2 (18th-19th day of withdrawal) and T3 (after 3 months of supplementation). The investigators hope to see a beneficial effect of omega-3 on social, emotional and cognitive deficits as well as brain functioning (fMRI). They will investigate the mechanisms involved, namely, changes in the composition of the gut microbiota, reduction of systemic inflammation, and production of bacterial metabolites with immune or neuroactive properties.

Interventions

DIETARY_SUPPLEMENTActive Comparator: Omega-3

It is a dietary supplement made of fish oil rich in n-3 PUFA.

DIETARY_SUPPLEMENTPlacebo Comparator: olive oil

Refined olive oil is the usual placebo used in studies with n-3 PUFA.

Sponsors

Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Double-blind

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of alcohol use disorder (≥ 4 DSM-5 criteria) * Patient at the hospital for a 3 week alcohol withdrawal program * Gender : male and female * Age : between 18 and 70 years old * Language : french * Alcohol consumption less than 48 jours before admission

Exclusion criteria

* Presence of another addiction, except for smoking and cannabis use * Presence of a psychiatric comorbidity (axis 1 DSM-5) * Current or recent use (\< 2 months) of antibiotics, probiotics, fibre supplements * Current or recent (\< 2 months) use of omega-3 supplements * Current or recent (\< 2 months) use of oral anti-coagulants drugs * Current or recent (\< 2 months) double anti-platelet therapy * Coagulation disorders * Current or recent (\< 1 month) use of non-steroidal anti-inflammatory drugs and glucocorticoids * Morbid obesity : body mass index \> 35 kg.m-2 * Bariatric surgery * Type I diabetes and type II diabetes not stabilised (i.e. glycated haemoglobin \> 7.2 and unstable drug treatments) * Chronic inflammatory diseases * Cancer (less than 5 years before admission) * Presence of cirrhosis (Fibroscan® = F4 and echodoppler performed as part of clinical routine on patient admission) * Known allergy to fish and seafood * Any other comorbidity that would be a contraindication to the study in the judgement of the principal investigator

Design outcomes

Primary

MeasureTime frameDescription
Change in social activityOn day 2, day 19 and day 90Social Activities Questionnaire (28-196)
Change in work memoryOn day 2, day 19 and day 90Letter Memory Task
Change in inhibitionOn day 2, day 19 and day 90Stop Signal Task
Change in decision makingOn day 19 and day 90Fisher Task
Change in facial emotions recognitionOn day 19 and day 90Facial Emotions Recognition Task (TREF)
Change in visual perspective takingOn day 19 and day 90Visual Perspective Taking Task
SociabilityOn day 19Sociogram
Emotional intelligenceDay 19Trait Emotional Intelligence Questionnaire (TEI Que-75) : calculation of score is complex and described in the related publication
Change in depressionOn day 2, day 19 and day 90Beck Depression Inventory (BDI) (score 0-63) Higher score indicates higher depression level.
Change in anxietyOn day 2, day 19 and day 90State-Trait Anxiety Inventory (STAI) (score 20-80) Higher score indicates higher anxiety level.
Change in fatigueOn day 2, day 19 and day 90Multidimensional Fatigue Inventory (MFI) (score 20-140) Higher score indicates higher fatigue level.
Change in alcohol cravingOn day 2, day 19 and day 90Obsessive Compulsive Drinking Scale (OCDS) (score 0-40) Higher score indicates higher craving level.
Change in impulsivityOn day 19 and day 90Urgency Premeditation Perseverance Sensation seeking impulsive behavior scale (UPPS) : score of different subscales are calculated : ugency (0-48), lack of premeditation (0-44), lack of perseverance (0-40), sensation seeking) (0-48). Higher score in the different subscales indicates higher impulsivity level.
Change in social anxietyOn day 19 and day 90Liebowitz Scale of Social Anxiety (EASL) (score 0-144) Higher score indicates higher social anxiety level.
Change in traumaOn day 19Post-traumatic diagnostic scale (PDS-F): calculation of score is complex and described in the related publication
Childhood traumaOn day 19Childhood Trauma Questionnaire (CTQ) (28-144) Higher score indicates higher childhood trauma level.
Self-stigmaOn day 19Self-Stigma in Alcohol Dependence (SSAD) (16-80) Higher score indicates higher self-stigma level.

Secondary

MeasureTime frameDescription
Change in inflammationOn day 2, day 19 and day 90Circulating pro- and anti-inflammatory cytokines (TNFa, IL-6, IL-1b, IL-8, IL-10) levels in blood sample Isolation of PBMC to study intracellular inflammatory pathways by RT-qPCR
Change in gut microbiota compositionOn day 2, day 19 and day 90Analysis of gut microbiota (16S rDNA) by high-throughput sequencing (Illumina)
Intestinal permeabilityOn day 19a duodenal biopsy will be collected and the expression of the tight junctions regulation the intestinal permeability will be analyzed by sectional immunofluorescence and quantitative polymerase chain reaction
Change in omega-3 levelsOn day 2, day 19 and day 90Omega-3 levels in plasma and red blood cells
Change in diet profileOn day 2, day 19 and day 90The dietary anamnesis will consist of a 24-hour recall over 3 days (2 weekdays and 1 weekend day)
Change in brain functioningOn day 2, day 19 and day 90Magnetic Resonance Imaging
Change in markers of microbial translocationOn day 2, day 19 and day 90measurement of sCD14, PGRP in blood sample using ELISA kits (pg/mL)

Countries

Belgium

Contacts

Primary ContactSophie Leclercq, PhD
sophie.leclercq@uclouvain.be+3224361023
Backup ContactMarie Mornard
marie.mornard@uclouvain.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026