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AlcoholismNCT03803709

Dietary Fiber Intake in Alcohol-dependent Patients

A study testing inulin in people with Alcoholism, run by Université Catholique de Louvain at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The alcohol problem affects 7.5% of the population in Europe and represents a major public health problem. Alcoholism is also a major cause of undernutrition. Diet is a major factor influencing the composition of the intestinal microbiota and previous studies, carried out at Saint-Luc clinics and catholic university… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcoholism
What is being tested?
inulin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteBelgium
Study dates
4 Jul 2017to Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • male or female
  • aged between 18 and 65
  • caucasian
  • French speaking
  • alcohol drunk less than 48h before day 1

Who cannot join

  • another addiction, except smoking
  • psychiatric comorbidity on axe 1 of Diagnostic and Statistical Manual-IV
  • antibiotic, probiotic or fibers recent (<2 months) treatment (or other molecule modifying intestinal transit)
  • Non-steroidial anti-inflammatory drug or glucocorticoids recently taken (<1 month)
  • obesity: Body Mass Index<30
  • bariatric surgery
Show all 10Show fewer
  • Type 1 or 2 diabetes
  • chronic inflammatory diseases (Crohn disease, coeliac disease, rheumatoid arthritis)
  • cirrhosis or Advanced hepatic fibrosis (Fibroscan > or = F3)
  • pregnancy

Trial locations and contacts

1 site in 1 country.

Peter Stärkel, MD, PhD contact

003227642853

peter.starkel@uclouvain.be

Belgium1 site, 1 recruiting

  • Université catholique de Louvain

    Brussels, 1200

    Peter Stärkel, MD, PhD, 003227642853, peter.starkel@uclouvain.be

    Peter Stärkel, MD, PhD

    Recruiting

Other trials in Belgium

About this study

The alcohol problem affects 7.5% of the population in Europe and represents a major public health problem. Alcoholism is also a major cause of undernutrition. Diet is a major factor influencing the composition of the intestinal microbiota and previous studies, carried out at Saint-Luc clinics and catholic university of Louvain, show that alcoholic patients suffer from dysbiosis, that is a significant alteration of the gut microbiota. The investigator's preliminary studies, carried out at the Integrated Unit of Hepatology of Saint-Luc Clinics, have shown that alcohol represents more than 40% of total caloric intake in alcohol-dependent patients. In addition, alcoholic patients have an insufficient intake of dietary fiber, that is to say a contribution lower than the Belgian nutritional recommendations. Indeed, the Conseil Supérieur de la Santé recommends a total amount of dietary fiber equal to or greater than 25 grams per day to ensure correct intestinal function. Fructan-type dietary fiber (inulin and fructo-oligosaccharides) is found naturally in many fruits and vegetables (Jerusalem artichokes, asparagus, artichokes, onions, garlic, chicory roots, bananas). They are neither absorbed nor digested by human enzymes but fermented selectively by intestinal bacteria.

A good digestive tolerance to dietary fiber supplementation has been observed in healthy subjects as well as in obese patients, in previous studies conducted at catholic university of Louvain and Saint-Luc clinics. However, a nutritional rebalance via fiber supplementation and digestive fiber tolerance have never been tested in an alcohol-dependent population.

Read more

The primary objectives of this academic research project in nutrition, carried out in alcohol-dependent patients, are as follows:

  1. restore a nutritional balance as recommended by the Conseil Supérieur de la Santé via a dietary fiber intake
  2. to study digestive tolerance to fibers
  3. to study the intestinal and psychological well-being related to a fiber intake

Depending on the results obtained during the achievement of the primary objectives, the biological samples (blood, stool) collected during the study will be used to analyze the composition of the intestinal microbiota and the plasma markers associated with intestinal function.

Conditions
Alcoholism
Being tested
inulin, placebo
Keywords
dietary fibers, alcohol-dependent
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • inulinDietary supplement

    inulin given at different dosis from day 3 to day 20

  • placeboDietary supplement

    maltodextrine given at different dosis from day 3 to day 20

Study groups in NCT03803709
Study groupRoleWhat they receive
placeboPlacebo comparator* maltodextrin received at 4g/day on day 3 and 4 * maltodextrin received at 8g/day from day 5 to 14 * maltodextrin received at 16g/day from day 15 to 20
Receives: Dietary Supplement: placebo
inulinExperimental* inulin received at 4g/day on day 3 and 4 * inulin received at 8g/day from day 5 to 14 * inulin received at 16g/day from day 15 to 20
Receives: Dietary Supplement: inulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in diet profile

    This tool is based on the one adapted to alcoholic patients at Saint Luc Hospital. It consists of two parts to allow cross-checking of data (redundancy) and to measure separate information:

    General: it is implemented a Food Frequency Questionnaire (FFQ) in order to investigate the general diet profile.

    Daily: it resumes the sequencing of a full day which allows to verify the information previously obtained as well as to precisely identify the moments of consumption of alcoholic and non-alcoholic inputs.

    This 7-day recall will be carried out at two times: week T1 for reminder of the week before hospitalization then T2 for reminder of the week back home. In this last case, this anamnesis will be done by interview, but also on the basis of the diary filled by the patient in T2, in order to optimize the accuracy of the data.

    Measured: on Day 2 and Day 19

Secondary outcomes (18)

  1. Alimentary book

    The patient will have to fill in this book every day

    Measured: From day 1 to day 21

  2. Quantitative evaluation of intakes

    The meals will be weighted before and after eating

    Measured: on Day 2 and Day 19

  3. Alimentation history

    This questionnaire makes it possible to further investigate the patient's diet before the episode of alcoholism in his adult and child life. The aim is to assess whether it is closer to a healthy diet (Mediterranean diet or dash diet) or a Western diet type. It is based on the recall technique and performed by a qualified dietician.

    Measured: On day 21

  4. Change in mood

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

    Measured: on Day 2 and Day 19

  5. Change in anxiety

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

    Measured: on Day 2 and Day 19

  6. Change in alcohol craving

    Obsessive Compulsive Drinking Scale: a total score (= obsession + compulsion) (0-40) and 2 sub-scores (Obsession (0-20) and Compulsion (0-20)) are calculated. Higher score indicates higher craving level.

    Measured: on Day 2 and Day 19

  7. Change in impulsivity

    Urgency Premeditation Perseverance Sensation seeking impulsive behavior scale: score of different subscales are calculated: "urgency"(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.

    Measured: on Day 2 and Day 19

  8. Change in selective attention

    William Lennox attention tests

    Measured: on Day 2 and Day 19

  9. Change in work memory

    Brown-Peterson's tasks

    Measured: on Day 2 and Day 19

  10. Change in flexibility

    Trail making test

    Measured: on Day 2 and Day 19

  11. Change in inhibition

    Scoop's tasks

    Measured: on Day 2 and Day 19

  12. Change in decision making

    Iowa gambling's task

    Measured: on Day 2 and Day 19

  13. Change in trauma

    Post-traumatic diagnostic scale: calculation of score is complex and described in the related publication 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.

    Measured: on Day 2 and Day 19

  14. Change in intestine integrity

    It will be determined by blood sample (LPS level)

    Measured: on Day 2 and Day 19

  15. Change in albumin, pre-albumin and zinc concentration

    It will be determined by blood sample

    Measured: on Day 2 and Day 19

  16. Change in intestinal permeability

    Patients will ingest 50microCurie of 51Chrome-Ethylenediamintetraacetic prepared in a Nutridrink®. This molecule is not normally absorbed by the intestine except when there is an increase in intestinal permeability (paracellular passage following rupture of tight junctions). The molecule is then filtered by the kidney and is found in the urine. A 24h urine collection will be carried out to measure the radioactivity emitted by 51Chrome-Ethylenediamintetraacetic

    Measured: on Day 2 and Day 19

  17. Change in fecal albumin concentration

    A stool sample will be collected to analyze a marker of intestinal permeability: fecal albumin

    Measured: on Day 2 and Day 19

  18. Intestinal permeability

    a duodenal biopsy will be collected and the expression of the tight junctions regulating the intestinal permeability will be analyzed by sectional immunofluorescence and quantitative Polymerase Chain reaction

    Measured: On day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start4 Jul 2017
  3. Primary completionJul 2022 (estimated)
  4. Study completionJul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03803709
Sponsor's protocol ID
190616V1
Other IDs
2017/04JUL/354
Status last verified
Dec 2018
First submitted
13 Dec 2018
Last updated
7 Feb 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Amadieu C, Ahmed H, Leclercq S, Koistinen V, Leyrolle Q, Starkel P, Bindels LB, Laye S, Neyrinck AM, Karkkainen O, De Timary P, Hanhineva K, Delzenne NM. Effect of inulin supplementation on fecal and blood metabolome in alcohol use disorder patients: A randomised, controlled dietary intervention. Clin Nutr ESPEN. 2025 Apr;66:361-371. doi: 10.1016/j.clnesp.2025.01.046. Epub 2025 Jan 27.

    PubMed 39864520

  • Amadieu C, Maccioni L, Leclercq S, Neyrinck AM, Delzenne NM, de Timary P, Starkel P. Liver alterations are not improved by inulin supplementation in alcohol use disorder patients during alcohol withdrawal: A pilot randomized, double-blind, placebo-controlled study. EBioMedicine. 2022 Jun;80:104033. doi: 10.1016/j.ebiom.2022.104033. Epub 2022 Apr 28.

    PubMed 35490461

  • Amadieu C, Coste V, Neyrinck AM, Thijssen V, Leyrolle Q, Bindels LB, Piessevaux H, Starkel P, de Timary P, Delzenne NM, Leclercq S. Restoring an adequate dietary fiber intake by inulin supplementation: a pilot study showing an impact on gut microbiota and sociability in alcohol use disorder patients. Gut Microbes. 2022 Jan-Dec;14(1):2007042. doi: 10.1080/19490976.2021.2007042.

    PubMed 34923905

  • Amadieu C, Leclercq S, Coste V, Thijssen V, Neyrinck AM, Bindels LB, Cani PD, Piessevaux H, Starkel P, de Timary P, Delzenne NM. Dietary fiber deficiency as a component of malnutrition associated with psychological alterations in alcohol use disorder. Clin Nutr. 2021 May;40(5):2673-2682. doi: 10.1016/j.clnu.2021.03.029. Epub 2021 Mar 30.

    PubMed 33933733

Questions about this trial

What is this clinical trial studying?

A study testing inulin in people with Alcoholism, run by Université Catholique de Louvain at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Peter Stärkel, MD, PhD (003227642853, peter.starkel@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in diet profile (time frame: on Day 2 and Day 19). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03803709, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.

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