Dietary Fiber Intake in Alcohol-dependent Patients

Alcoholism Clinical Trial

Official title:

Dietary Fiber Intake in Alcohol-dependent Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03803709
• Other study ID #: 190616V1
• Secondary ID: 2017/04JUL/354
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2017
• Est. completion date: July 2022

Study information

• Verified date: December 2018
• Source: Université Catholique de Louvain
• Contact: Peter Stärkel, MD, PhD
• Phone: 003227642853
• Email: peter.starkel[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism

Intervention

Dietary Supplement:
• inulin
inulin given at different dosis from day 3 to day 20
• placebo
maltodextrine given at different dosis from day 3 to day 20

Locations

Country	Name	City	State
Belgium	Université catholique de Louvain	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Alimentary book	The patient will have to fill in this book every day	From day 1 to day 21
Secondary	Quantitative evaluation of intakes	The meals will be weighted before and after eating	on Day 2 and Day 19
Secondary	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.	On day 21
Secondary	Change in mood	Beck Depression Inventory (score 0-63). Higher score indicates higher depression level.	on Day 2 and Day 19
Secondary	Change in anxiety	State-Trait Anxiety Inventory (score 20-80). Higher score indicates higher anxiety level.	on Day 2 and Day 19
Secondary	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.	on Day 2 and Day 19
Secondary	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.	on Day 2 and Day 19
Secondary	Change in selective attention	William Lennox attention tests	on Day 2 and Day 19
Secondary	Change in work memory	Brown-Peterson's tasks	on Day 2 and Day 19
Secondary	Change in flexibility	Trail making test	on Day 2 and Day 19
Secondary	Change in inhibition	Scoop's tasks	on Day 2 and Day 19
Secondary	Change in decision making	Iowa gambling's task	on Day 2 and Day 19
Secondary	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.	on Day 2 and Day 19
Secondary	Change in intestine integrity	It will be determined by blood sample (LPS level)	on Day 2 and Day 19
Secondary	Change in albumin, pre-albumin and zinc concentration	It will be determined by blood sample	on Day 2 and Day 19
Secondary	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	on Day 2 and Day 19
Secondary	Change in fecal albumin concentration	A stool sample will be collected to analyze a marker of intestinal permeability: fecal albumin	on Day 2 and Day 19
Secondary	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	On day 3