Impact of Omega 3 in Alcohol Use Disorder

NCT05899660 | Recruiting

• 1 other identifier: 2022/22DEC/502
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder, Severe

Keywords

gut microbiota; Omega 3; metabolomics; Depression; Anxiety; Alcohol craving; Sociability; Cognition; Inflammation; Brain imaging

Outcome Measures

Primary Outcomes (17)

• Change in depression

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

  On day 2, day 19 and day 90

• Change in anxiety

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

  On day 2, day 19 and day 90

• Change in fatigue

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

  On day 2, day 19 and day 90

• Change in alcohol craving

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

  On day 2, day 19 and day 90

• Change in impulsivity

  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.

  On day 19 and day 90

• Change in social anxiety

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

  On day 19 and day 90

• Change in trauma

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

  On day 19

• Childhood trauma

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

  On day 19

• Self-stigma

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

  On day 19

• Change in work memory

  Letter Memory Task

  On day 2, day 19 and day 90

• Change in inhibition

  Stop Signal Task

  On day 2, day 19 and day 90

• Change in decision making

  Fisher Task

  On day 19 and day 90

• Change in facial emotions recognition

  Facial Emotions Recognition Task (TREF)

  On day 19 and day 90

• Change in visual perspective taking

  Visual Perspective Taking Task

  On day 19 and day 90

• Sociability

  Sociogram

  On day 19

• Emotional intelligence

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

  Day 19

• Change in social activity

  Social Activities Questionnaire (28-196)

  On day 2, day 19 and day 90

Secondary Outcomes (7)

• Change in markers of microbial translocation

  On day 2, day 19 and day 90

• Change in inflammation

  On day 2, day 19 and day 90

• Change in gut microbiota composition

  On day 2, day 19 and day 90

• Intestinal permeability

  On day 19

• Change in omega-3 levels

  On day 2, day 19 and day 90

Study Arms (2)

Olive oil

PLACEBO COMPARATOR

Dosage form : capsule Dosage : 1000 mg oleic acid (olive oil) + 3.6 mg D-α-tocopherol (vitamin E) Frequency : 4 capsules per day Duration : 3 months

Dietary Supplement: Placebo Comparator: olive oil

Omega-3

ACTIVE COMPARATOR

Dosage form : capsule Dosage : 330 mg EPA, 220 mg DHA, 100 mg other n-3 PUFA + 3.6 mg D-α-tocopherol (vitamin E) Frequency : 4 capsules per day Duration : 3 months

Dietary Supplement: Active Comparator: Omega-3

Interventions

Active Comparator: Omega-3 DIETARY_SUPPLEMENT

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

Omega-3

Placebo Comparator: olive oil DIETARY_SUPPLEMENT

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

Olive oil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (2)

• Hearn, M, Ceschi, G., Brillon, P, Fürst, G., & Van der Linden, M. (2012). A French adaptation of the Post-traumatic Diagnostic scale. Canadian Journal of Behavioural Science, 44, 16-28

  BACKGROUND

• Petrides KV (2009) Psychometric properties of the trait emotional intelligence questionnaire. In: Stough C, Saklofske DH, Parker JD (eds) Advances in the assessment of emotional intelligence. Springer, New York. 10.1007/978-0-387-88370-0_5

  BACKGROUND

MeSH Terms

Conditions

Alcoholism; Depression; Anxiety Disorders; Inflammation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe de Timary, MD, PhD

  St Luc academic Hospital and Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

• Peter Starkel, MD, PhD

  St Luc academic Hospital and Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Leclercq, PhD

CONTACT

+3224361023; sophie.leclercq@uclouvain.be

Marie Mornard

CONTACT

marie.mornard@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 12, 2023
• Study Start: June 19, 2023
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)