Cliniques universitaires Saint Luc
Brussels, 1200, Belgium
Location status: Recruiting
NCT Number: NCT05899660
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Brussels, 1200, Belgium
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
It is a dietary supplement made of fish oil rich in n-3 PUFA.
Refined olive oil is the usual placebo used in studies with n-3 PUFA.
Time frame: On day 2, day 19 and day 90
Beck Depression Inventory (BDI) (score 0-63) Higher score indicates higher depression level.
Time frame: On day 2, day 19 and day 90
State-Trait Anxiety Inventory (STAI) (score 20-80) Higher score indicates higher anxiety level.
Time frame: On day 2, day 19 and day 90
Multidimensional Fatigue Inventory (MFI) (score 20-140) Higher score indicates higher fatigue level.
Time frame: On day 2, day 19 and day 90
Obsessive Compulsive Drinking Scale (OCDS) (score 0-40) Higher score indicates higher craving level.
Time frame: 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.
Time frame: On day 19 and day 90
Liebowitz Scale of Social Anxiety (EASL) (score 0-144) Higher score indicates higher social anxiety level.
Time frame: On day 19
Post-traumatic diagnostic scale (PDS-F): calculation of score is complex and described in the related publication
Time frame: On day 19
Childhood Trauma Questionnaire (CTQ) (28-144) Higher score indicates higher childhood trauma level.
Time frame: On day 19
Self-Stigma in Alcohol Dependence (SSAD) (16-80) Higher score indicates higher self-stigma level.
Time frame: On day 2, day 19 and day 90
Letter Memory Task
Time frame: On day 2, day 19 and day 90
Stop Signal Task
Time frame: On day 19 and day 90
Fisher Task
Time frame: On day 19 and day 90
Facial Emotions Recognition Task (TREF)
Time frame: On day 19 and day 90
Visual Perspective Taking Task
Time frame: On day 19
Sociogram
Time frame: Day 19
Trait Emotional Intelligence Questionnaire (TEI Que-75) : calculation of score is complex and described in the related publication
Time frame: On day 2, day 19 and day 90
Social Activities Questionnaire (28-196)
Time frame: On day 2, day 19 and day 90
measurement of sCD14, PGRP in blood sample using ELISA kits (pg/mL)
Time frame: On day 2, day 19 and day 90
Circulating 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
Time frame: On day 2, day 19 and day 90
Analysis of gut microbiota (16S rDNA) by high-throughput sequencing (Illumina)
Time frame: On day 19
a 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
Time frame: On day 2, day 19 and day 90
Omega-3 levels in plasma and red blood cells
Time frame: On day 2, day 19 and day 90
The dietary anamnesis will consist of a 24-hour recall over 3 days (2 weekdays and 1 weekend day)
Time frame: On day 2, day 19 and day 90
Magnetic Resonance Imaging
Contact information is provided by the study sponsor or research team.
Université Catholique de Louvain
Other
Impact of Omega-3 Polyunsaturated Fatty Acids on Emotional, Cognitive and Biological Alterations in Alcohol Use Disorder
Acronym: W3-AUD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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