Dietary Fiber Intake in Alcohol-dependent Patients
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StatusRekrutacyjny
Sponsorzy
Université Catholique de Louvain
BADANIE KLINICZNE: NCT03803709
BioSeek: nct03803709
Słowa kluczowe
Abstrakcyjny
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.
Daktyle
| Ostatnia weryfikacja: | 11/30/2018 |
| Pierwsze przesłane: | 12/12/2018 |
| Szacowana liczba przesłanych rejestracji: | 01/09/2019 |
| Wysłany pierwszy: | 01/14/2019 |
| Ostatnia aktualizacja przesłana: | 02/04/2019 |
| Ostatnia opublikowana aktualizacja: | 02/06/2019 |
| Rzeczywista data rozpoczęcia badania: | 07/03/2017 |
| Szacowana data zakończenia podstawowej działalności: | 06/30/2022 |
| Szacowana data zakończenia badania: | 06/30/2022 |
Stan lub choroba
Alcoholism
Interwencja / leczenie
Dietary Supplement: inulin
Dietary Supplement: placebo
Faza
-
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| 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 | Dietary Supplement: placebo maltodextrine given at different dosis from day 3 to day 20 |
| 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 | Dietary Supplement: inulin inulin given at different dosis from day 3 to day 20 |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
| Płeć kwalifikująca się do nauki | All |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | 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 |
Wynik
Podstawowe miary wyników
1. Change in diet profile [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.
Miary wyników wtórnych
1. Alimentary book [From day 1 to day 21]
The patient will have to fill in this book every day
2. Quantitative evaluation of intakes [on Day 2 and Day 19]
The meals will be weighted before and after eating
3. Alimentation history [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.
4. Change in mood [on Day 2 and Day 19]
Beck Depression Inventory (score 0-63). Higher score indicates higher depression level.
5. Change in anxiety [on Day 2 and Day 19]
State-Trait Anxiety Inventory (score 20-80). Higher score indicates higher anxiety level.
6. Change in alcohol craving [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.
7. Change in impulsivity [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.
8. Change in selective attention [on Day 2 and Day 19]
William Lennox attention tests
9. Change in work memory [on Day 2 and Day 19]
Brown-Peterson's tasks
10. Change in flexibility [on Day 2 and Day 19]
Trail making test
11. Change in inhibition [on Day 2 and Day 19]
Scoop's tasks
12. Change in decision making [on Day 2 and Day 19]
Iowa gambling's task
13. Change in trauma [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.
14. Change in intestine integrity [on Day 2 and Day 19]
It will be determined by blood sample (LPS level)
15. Change in albumin, pre-albumin and zinc concentration [on Day 2 and Day 19]
It will be determined by blood sample
16. Change in intestinal permeability [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
17. Change in fecal albumin concentration [on Day 2 and Day 19]
A stool sample will be collected to analyze a marker of intestinal permeability: fecal albumin
18. Intestinal permeability [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
