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Trial record 2 of 2 for:    Iowa + banana

Dietary Fiber Intake in Alcohol-dependent Patients

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ClinicalTrials.gov Identifier: NCT03803709
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Université Catholique de Louvain

Tracking Information
First Submitted Date  ICMJE December 13, 2018
First Posted Date  ICMJE January 15, 2019
Last Update Posted Date February 7, 2019
Actual Study Start Date  ICMJE July 4, 2017
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
Change in diet profile [ Time Frame: on Day 2 and Day 19 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
  • Alimentary book [ Time Frame: From day 1 to day 21 ]
    The patient will have to fill in this book every day
  • Quantitative evaluation of intakes [ Time Frame: on Day 2 and Day 19 ]
    The meals will be weighted before and after eating
  • Alimentation history [ Time Frame: On day 21 ]
    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 [ Time Frame: on Day 2 and Day 19 ]
    Beck Depression Inventory (score 0-63). Higher score indicates higher depression level.
  • Change in anxiety [ Time Frame: on Day 2 and Day 19 ]
    State-Trait Anxiety Inventory (score 20-80). Higher score indicates higher anxiety level.
  • Change in alcohol craving [ Time Frame: on Day 2 and Day 19 ]
    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 [ Time Frame: on Day 2 and Day 19 ]
    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 [ Time Frame: on Day 2 and Day 19 ]
    William Lennox attention tests
  • Change in work memory [ Time Frame: on Day 2 and Day 19 ]
    Brown-Peterson's tasks
  • Change in flexibility [ Time Frame: on Day 2 and Day 19 ]
    Trail making test
  • Change in inhibition [ Time Frame: on Day 2 and Day 19 ]
    Scoop's tasks
  • Change in decision making [ Time Frame: on Day 2 and Day 19 ]
    Iowa gambling's task
  • Change in trauma [ Time Frame: on Day 2 and Day 19 ]
    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 [ Time Frame: on Day 2 and Day 19 ]
    It will be determined by blood sample (LPS level)
  • Change in albumin, pre-albumin and zinc concentration [ Time Frame: on Day 2 and Day 19 ]
    It will be determined by blood sample
  • Change in intestinal permeability [ Time Frame: on Day 2 and Day 19 ]
    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 [ Time Frame: on Day 2 and Day 19 ]
    A stool sample will be collected to analyze a marker of intestinal permeability: fecal albumin
  • Intestinal permeability [ Time Frame: On day 3 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • Alimentary book [ Time Frame: From day 1 to day 21 ]
    The patient will have to fill in this book every day
  • Quantitative evaluation of intakes [ Time Frame: on Day 2 and Day 19 ]
    The meals will be weighted before and after eating
  • Alimentation history [ Time Frame: On day 21 ]
    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 [ Time Frame: on Day 2 and Day 19 ]
    Beck Depression Inventory (score 0-63). Higher score indicates higher depression level.
  • Change in anxiety [ Time Frame: on Day 2 and Day 19 ]
    State-Trait Anxiety Inventory (score 20-80). Higher score indicates higher anxiety level.
  • Change in alcohol craving [ Time Frame: on Day 2 and Day 19 ]
    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 [ Time Frame: on Day 2 and Day 19 ]
    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 [ Time Frame: on Day 2 and Day 19 ]
    William Lennox attention tests
  • Change in work memory [ Time Frame: on Day 2 and Day 19 ]
    Brown-Peterson's tasks
  • Change in flexibility [ Time Frame: on Day 2 and Day 19 ]
    Trail making test
  • Change in inhibition [ Time Frame: on Day 2 and Day 19 ]
    Scoop's tasks
  • Change in decision making [ Time Frame: on Day 2 and Day 19 ]
    Iowa gambling's task
  • Change in trauma [ Time Frame: on Day 2 and Day 19 ]
    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 [ Time Frame: on Day 2 and Day 19 ]
    It will be determined by blood sample (LPS level)
  • Change in nutritional state [ Time Frame: on Day 2 and Day 19 ]
    It will be determined by blood sample (albumin, pre-albumin, zinc)
  • Change in intestinal permeability [ Time Frame: on Day 2 and Day 19 ]
    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 intestinal permeability [ Time Frame: on Day 2 and Day 19 ]
    A stool sample will be collected to analyze a marker of intestinal permeability: fecal albumin
  • Intestinal permeability [ Time Frame: On day 3 ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Fiber Intake in Alcohol-dependent Patients
Official Title  ICMJE Dietary Fiber Intake in Alcohol-dependent Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Alcoholism
Intervention  ICMJE
  • Dietary Supplement: inulin
    inulin given at different dosis from day 3 to day 20
  • Dietary Supplement: placebo
    maltodextrine given at different dosis from day 3 to day 20
Study Arms  ICMJE
  • Placebo Comparator: placebo
    • 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
    Intervention: Dietary Supplement: placebo
  • Experimental: inulin
    • 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: Dietary Supplement: inulin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 10, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peter Stärkel, MD, PhD 003227642853 peter.starkel@uclouvain.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03803709
Other Study ID Numbers  ICMJE 190616V1
2017/04JUL/354 ( Other Identifier: Ethics Committee CEHF )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Université Catholique de Louvain
Study Sponsor  ICMJE Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Université Catholique de Louvain
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP