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UnknownNCT03803709

Dietary Fiber Intake in Alcohol-dependent Patients

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Université Catholique de Louvain · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTinulininulin given at different dosis from day 3 to day 20
DIETARY_SUPPLEMENTplacebomaltodextrine given at different dosis from day 3 to day 20

Timeline

Start date
2017-07-04
Primary completion
2022-07-01
Completion
2022-07-01
First posted
2019-01-15
Last updated
2019-02-07

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03803709. Inclusion in this directory is not an endorsement.