Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05899660

Impact of Omega 3 in Alcohol Use Disorder

Led by Université Catholique de Louvain · Updated on 2023-06-22

100

Participants Needed

1

Research Sites

236 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Impact of Omega 3 in Alcohol Use Disorder

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of alcohol use disorder (at least 4 DSM-5 criteria)
  • Patient admitted for a 3-week alcohol withdrawal program
  • Male or female gender
  • Age between 18 and 70 years old
  • French speaking
  • Alcohol consumption within 48 hours before admission
Not Eligible

You will not qualify if you...

  • Presence of another addiction except smoking and cannabis use
  • Psychiatric comorbidity (axis 1 DSM-5)
  • Use of antibiotics, probiotics, or fiber supplements within the last 2 months
  • Use of omega-3 supplements within the last 2 months
  • Use of oral anti-coagulants within the last 2 months
  • Use of double anti-platelet therapy within the last 2 months
  • Coagulation disorders
  • Use of non-steroidal anti-inflammatory drugs or glucocorticoids within the last month
  • Morbid obesity with body mass index over 35 kg/m2
  • History of bariatric surgery
  • Type 1 diabetes or unstable type 2 diabetes
  • Chronic inflammatory diseases
  • Cancer diagnosed less than 5 years ago
  • Presence of cirrhosis (Fibroscan F4 and echodoppler confirmed)
  • Known allergy to fish and seafood
  • Any other medical condition that contraindicates participation as judged by the principal investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cliniques universitaires Saint Luc

Brussels, Belgium, 1200

Actively Recruiting

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Research Team

S

Sophie Leclercq, PhD

CONTACT

M

Marie Mornard

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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