NCT05899660 Impact of Omega 3 in Alcohol Use Disorder
| NCT ID | NCT05899660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Université Catholique de Louvain |
| Condition | Alcohol Use Disorder, Severe |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-06-19 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-06-19 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Philippe de Timary, MD, PhD
PRINCIPAL INVESTIGATOR
St Luc academic Hospital and Université Catholique de Louvain
Frequently Asked Questions
Who can join the NCT05899660 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Alcohol Use Disorder, Severe. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05899660 currently recruiting?
Yes, NCT05899660 is actively recruiting participants. Contact the research team at sophie.leclercq@uclouvain.be for enrollment information.
Where is the NCT05899660 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT05899660 clinical trial?
NCT05899660 is sponsored by Université Catholique de Louvain. The principal investigator is Philippe de Timary, MD, PhD at St Luc academic Hospital and Université Catholique de Louvain. The trial plans to enroll 100 participants.