Recruiting

Impact of Omega 3 in Alcohol Use Disorder

ClinicalTrials.gov IDNCT05899660

PhaseNA

Enrollment100

SponsorUniversité Catholique de Louvain

Age18 Years

SexALL

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Conditions studied

Alcohol Use Disorder, Severe

About this study

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.

Interventions

Dietary Supplement: Active Comparator: Omega-3 — It is a dietary supplement made of fish oil rich in n-3 PUFA.
Dietary Supplement: Placebo Comparator: olive oil — Refined olive oil is the usual placebo used in studies with n-3 PUFA.

Primary outcomes

Change in depression (On day 2, day 19 and day 90)
Change in anxiety (On day 2, day 19 and day 90)
Change in fatigue (On day 2, day 19 and day 90)
Change in alcohol craving (On day 2, day 19 and day 90)
Change in impulsivity (On day 19 and day 90)
Change in social anxiety (On day 19 and day 90)
Change in trauma (On day 19)
Childhood trauma (On day 19)

Eligibility information

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

Study locations

Cliniques universitaires Saint Luc, Brussels, 1200 Belgium

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.