Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05899660

Impact of Omega 3 in Alcohol Use Disorder

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint Luc

Brussels, 1200, Belgium

Location status: Recruiting

Location contact

Marie Mornard

CONTACT

[email protected]

Sophie Leclercq

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Comparator: Omega-3

Dietary Supplement

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

Placebo Comparator: olive oil

Dietary Supplement

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

Primary outcomes

  1. Change in depression

    Time frame: On day 2, day 19 and day 90

    Beck Depression Inventory (BDI) (score 0-63) Higher score indicates higher depression level.

  2. Change in anxiety

    Time frame: On day 2, day 19 and day 90

    State-Trait Anxiety Inventory (STAI) (score 20-80) Higher score indicates higher anxiety level.

  3. Change in fatigue

    Time frame: On day 2, day 19 and day 90

    Multidimensional Fatigue Inventory (MFI) (score 20-140) Higher score indicates higher fatigue level.

  4. Change in alcohol craving

    Time frame: On day 2, day 19 and day 90

    Obsessive Compulsive Drinking Scale (OCDS) (score 0-40) Higher score indicates higher craving level.

  5. Change in impulsivity

    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.

  6. Change in social anxiety

    Time frame: On day 19 and day 90

    Liebowitz Scale of Social Anxiety (EASL) (score 0-144) Higher score indicates higher social anxiety level.

  7. Change in trauma

    Time frame: On day 19

    Post-traumatic diagnostic scale (PDS-F): calculation of score is complex and described in the related publication

  8. Childhood trauma

    Time frame: On day 19

    Childhood Trauma Questionnaire (CTQ) (28-144) Higher score indicates higher childhood trauma level.

  9. Self-stigma

    Time frame: On day 19

    Self-Stigma in Alcohol Dependence (SSAD) (16-80) Higher score indicates higher self-stigma level.

  10. Change in work memory

    Time frame: On day 2, day 19 and day 90

    Letter Memory Task

  11. Change in inhibition

    Time frame: On day 2, day 19 and day 90

    Stop Signal Task

  12. Change in decision making

    Time frame: On day 19 and day 90

    Fisher Task

  13. Change in facial emotions recognition

    Time frame: On day 19 and day 90

    Facial Emotions Recognition Task (TREF)

  14. Change in visual perspective taking

    Time frame: On day 19 and day 90

    Visual Perspective Taking Task

  15. Sociability

    Time frame: On day 19

    Sociogram

  16. Emotional intelligence

    Time frame: Day 19

    Trait Emotional Intelligence Questionnaire (TEI Que-75) : calculation of score is complex and described in the related publication

  17. Change in social activity

    Time frame: On day 2, day 19 and day 90

    Social Activities Questionnaire (28-196)

Secondary outcomes

  1. Change in markers of microbial translocation

    Time frame: On day 2, day 19 and day 90

    measurement of sCD14, PGRP in blood sample using ELISA kits (pg/mL)

  2. Change in inflammation

    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

  3. Change in gut microbiota composition

    Time frame: On day 2, day 19 and day 90

    Analysis of gut microbiota (16S rDNA) by high-throughput sequencing (Illumina)

  4. Intestinal permeability

    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

  5. Change in omega-3 levels

    Time frame: On day 2, day 19 and day 90

    Omega-3 levels in plasma and red blood cells

  6. Change in diet profile

    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)

  7. Change in brain functioning

    Time frame: On day 2, day 19 and day 90

    Magnetic Resonance Imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Mornard

CONTACT

[email protected]

Sophie Leclercq, PhD

CONTACT

[email protected]

+3224361023

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

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

Acronym: W3-AUD

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Jun 12, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.