Dietary Fiber Intake in Alcohol-dependent Patients
2 other identifiers
interventional
40
1 country
1
Brief 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 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 4, 2017
CompletedFirst Submitted
Initial submission to the registry
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedFebruary 7, 2019
December 1, 2018
5 years
December 13, 2018
February 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
on Day 2 and Day 19
Secondary Outcomes (18)
Alimentary book
From day 1 to day 21
Quantitative evaluation of intakes
on Day 2 and Day 19
Alimentation history
On day 21
Change in mood
on Day 2 and Day 19
Change in anxiety
on Day 2 and Day 19
- +13 more secondary outcomes
Study Arms (2)
placebo
PLACEBO 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
inulin
EXPERIMENTAL* 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
Interventions
Eligibility Criteria
You may qualify if:
- male or female
- aged between 18 and 65
- caucasian
- French speaking
- alcohol drunk less than 48h before day 1
You may not qualify if:
- 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
- Type 1 or 2 diabetes
- chronic inflammatory diseases (Crohn disease, coeliac disease, rheumatoid arthritis)
- cirrhosis or Advanced hepatic fibrosis (Fibroscan \> or = F3)
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Université catholique de Louvain
Brussels, 1200, Belgium
Related Publications (4)
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.
PMID: 39864520DERIVEDAmadieu 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.
PMID: 35490461DERIVEDAmadieu 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.
PMID: 34923905DERIVEDAmadieu 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.
PMID: 33933733DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2018
First Posted
January 15, 2019
Study Start
July 4, 2017
Primary Completion
July 1, 2022
Study Completion
July 1, 2022
Last Updated
February 7, 2019
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share