Dietary Fiber Intake in Alcohol-dependent Patients

U

Université Catholique de Louvain

Status

Unknown

Conditions

Alcoholism

Treatments

Dietary Supplement: inulin
Dietary Supplement: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03803709
190616V1
2017/04JUL/354 (Other Identifier)

Details and patient eligibility

About

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: restore a nutritional balance as recommended by the Conseil Supérieur de la Santé via a dietary fiber intake to study digestive tolerance to fibers 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups, including a placebo group

placebo
Placebo Comparator group
Description:
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
Treatment:
Dietary Supplement: placebo
inulin
Experimental group
Description:
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
Treatment:
Dietary Supplement: inulin

Trial contacts and locations

1

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Central trial contact

Peter Stärkel, MD, PhD

Data sourced from clinicaltrials.gov

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