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Impact of Omega 3 in Alcohol Use Disorder

NCT05899660 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-06-22

No results posted yet for this 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.

Conditions

  • Alcohol Use Disorder, Severe

Interventions

DIETARY_SUPPLEMENT

Active Comparator: Omega-3

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

DIETARY_SUPPLEMENT

Placebo Comparator: olive oil

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

Sponsors & Collaborators

  • Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Philippe de Timary, MD, PhD · St Luc academic Hospital and Université Catholique de Louvain

  • Peter Starkel, MD, PhD · St Luc academic Hospital and Université Catholique de Louvain

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-19
Primary Completion
2024-12-01
Completion
2027-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05899660 on ClinicalTrials.gov