Impact of Omega 3 in Alcohol Use Disorder
Recruiting · NCT05899660 · Interventional (participants receive a specific treatment) · Lead sponsor: Université Catholique de Louvain
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Cliniques universitaires Saint Luc - Brussels, Belgium