Clinical trial NCT03803709: Dietary Fiber Intake in Alcohol-dependent Patients
Official title: Dietary Fiber Intake in Alcohol-dependent Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcoholism
Keywords: dietary fibers
alcohol-dependent
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in diet profile
timeFrame: on Day 2 and Day 19
Secondary outcomes:
measure: Alimentary book
timeFrame: From day 1 to day 21
measure: Quantitative evaluation of intakes
timeFrame: on Day 2 and Day 19
measure: Alimentation history
timeFrame: On day 21
measure: Change in mood
timeFrame: on Day 2 and Day 19
measure: Change in anxiety
timeFrame: on Day 2 and Day 19
measure: Change in alcohol craving
timeFrame: on Day 2 and Day 19
measure: Change in impulsivity
timeFrame: on Day 2 and Day 19
measure: Change in selective attention
timeFrame: on Day 2 and Day 19
measure: Change in work memory
timeFrame: on Day 2 and Day 19
measure: Change in flexibility
timeFrame: on Day 2 and Day 19
measure: Change in inhibition
timeFrame: on Day 2 and Day 19
measure: Change in decision making
timeFrame: on Day 2 and Day 19
measure: Change in trauma
timeFrame: on Day 2 and Day 19
measure: Change in intestine integrity
timeFrame: on Day 2 and Day 19
measure: Change in albumin, pre-albumin and zinc concentration
timeFrame: on Day 2 and Day 19
measure: Change in intestinal permeability
timeFrame: on Day 2 and Day 19
measure: Change in fecal albumin concentration
timeFrame: on Day 2 and Day 19
measure: Intestinal permeability
timeFrame: On day 3
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Université catholique de Louvain
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.