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Dietary Fiber Intake in Alcohol-dependent Patients

Primary Purpose

Alcoholism

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
inulin
placebo
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcoholism focused on measuring dietary fibers, alcohol-dependent

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Université catholique de LouvainRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

inulin

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 13, 2018
Last Updated
February 5, 2019
Sponsor
Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03803709
Brief Title
Dietary Fiber Intake in Alcohol-dependent Patients
Official Title
Dietary Fiber Intake in Alcohol-dependent Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 4, 2017 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
dietary fibers, alcohol-dependent

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm 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
Arm Title
inulin
Arm Type
Experimental
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
inulin
Intervention Description
inulin given at different dosis from day 3 to day 20
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
maltodextrine given at different dosis from day 3 to day 20
Primary Outcome Measure Information:
Title
Change in diet profile
Description
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.
Time Frame
on Day 2 and Day 19
Secondary Outcome Measure Information:
Title
Alimentary book
Description
The patient will have to fill in this book every day
Time Frame
From day 1 to day 21
Title
Quantitative evaluation of intakes
Description
The meals will be weighted before and after eating
Time Frame
on Day 2 and Day 19
Title
Alimentation history
Description
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.
Time Frame
On day 21
Title
Change in mood
Description
Beck Depression Inventory (score 0-63). Higher score indicates higher depression level.
Time Frame
on Day 2 and Day 19
Title
Change in anxiety
Description
State-Trait Anxiety Inventory (score 20-80). Higher score indicates higher anxiety level.
Time Frame
on Day 2 and Day 19
Title
Change in alcohol craving
Description
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.
Time Frame
on Day 2 and Day 19
Title
Change in impulsivity
Description
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.
Time Frame
on Day 2 and Day 19
Title
Change in selective attention
Description
William Lennox attention tests
Time Frame
on Day 2 and Day 19
Title
Change in work memory
Description
Brown-Peterson's tasks
Time Frame
on Day 2 and Day 19
Title
Change in flexibility
Description
Trail making test
Time Frame
on Day 2 and Day 19
Title
Change in inhibition
Description
Scoop's tasks
Time Frame
on Day 2 and Day 19
Title
Change in decision making
Description
Iowa gambling's task
Time Frame
on Day 2 and Day 19
Title
Change in trauma
Description
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.
Time Frame
on Day 2 and Day 19
Title
Change in intestine integrity
Description
It will be determined by blood sample (LPS level)
Time Frame
on Day 2 and Day 19
Title
Change in albumin, pre-albumin and zinc concentration
Description
It will be determined by blood sample
Time Frame
on Day 2 and Day 19
Title
Change in intestinal permeability
Description
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
Time Frame
on Day 2 and Day 19
Title
Change in fecal albumin concentration
Description
A stool sample will be collected to analyze a marker of intestinal permeability: fecal albumin
Time Frame
on Day 2 and Day 19
Title
Intestinal permeability
Description
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
Time Frame
On day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Stärkel, MD, PhD
Phone
003227642853
Email
peter.starkel@uclouvain.be
Facility Information:
Facility Name
Université catholique de Louvain
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Stärkel, MD, PhD
Phone
003227642853
Email
peter.starkel@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Peter Stärkel, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nathalie Delzenne, PhD
First Name & Middle Initial & Last Name & Degree
Sophie Leclercq, PhD
First Name & Middle Initial & Last Name & Degree
Philippe de Timary, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35490461
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.
Results Reference
derived
PubMed Identifier
34923905
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.
Results Reference
derived
PubMed Identifier
33933733
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.
Results Reference
derived

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Dietary Fiber Intake in Alcohol-dependent Patients

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