Active Comparator: Omega-3Placebo Comparator: olive oil
Active Comparator: Omega-3: It is a dietary supplement made of fish oil rich in n-3 PUFA.
Placebo Comparator: olive oil: Refined olive oil is the usual placebo used in studies with n-3 PUFA.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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
Primary outcome measure(s)
Change in depression — On day 2, day 19 and day 90 Beck Depression Inventory (BDI) (score 0-63) Higher score indicates higher depression level.
Change in anxiety — On day 2, day 19 and day 90 State-Trait Anxiety Inventory (STAI) (score 20-80) Higher score indicates higher anxiety level.
Change in fatigue — On day 2, day 19 and day 90 Multidimensional Fatigue Inventory (MFI) (score 20-140) Higher score indicates higher fatigue level.
Change in alcohol craving — On day 2, day 19 and day 90 Obsessive Compulsive Drinking Scale (OCDS) (score 0-40) Higher score indicates higher craving level.
Change in impulsivity — On day 19 and day 90 Urgency 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 anxiety — On day 19 and day 90 Liebowitz Scale of Social Anxiety (EASL) (score 0-144) Higher score indicates higher social anxiety level.
Change in trauma — On day 19 Post-traumatic diagnostic scale (PDS-F): calculation of score is complex and described in the related publication
Childhood trauma — On day 19 Childhood Trauma Questionnaire (CTQ) (28-144) Higher score indicates higher childhood trauma level.
Self-stigma — On day 19 Self-Stigma in Alcohol Dependence (SSAD) (16-80) Higher score indicates higher self-stigma level.
Change in work memory — On day 2, day 19 and day 90 Letter Memory Task
Change in inhibition — On day 2, day 19 and day 90 Stop Signal Task
Change in decision making — On day 19 and day 90 Fisher Task
Change in facial emotions recognition — On day 19 and day 90 Facial Emotions Recognition Task (TREF)
Change in visual perspective taking — On day 19 and day 90 Visual Perspective Taking Task
Sociability — On day 19 Sociogram
Emotional intelligence — Day 19 Trait Emotional Intelligence Questionnaire (TEI Que-75) : calculation of score is complex and described in the related publication
Change in social activity — On day 2, day 19 and day 90 Social Activities Questionnaire (28-196)
Trial sites (1)
Facility
City
Region
Status
Cliniques universitaires Saint Luc
Brussels
Belgium
Recruiting
More Université Catholique de Louvain trials in Belgium
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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