Dietary Fiber Intake in Alcohol-dependent Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in diet profile
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female
- •aged between 18 and 65
- •caucasian
- •French speaking
- •alcohol drunk less than 48h before day 1
排除标准
- •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
结局指标
主要结局
Change in diet profile
时间窗: 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.
次要结局
- Change in mood(on Day 2 and Day 19)
- Change in decision making(on Day 2 and Day 19)
- Change in trauma(on Day 2 and Day 19)
- Alimentary book(From day 1 to day 21)
- Change in selective attention(on Day 2 and Day 19)
- Change in flexibility(on Day 2 and Day 19)
- Change in fecal albumin concentration(on Day 2 and Day 19)
- Change in inhibition(on Day 2 and Day 19)
- Quantitative evaluation of intakes(on Day 2 and Day 19)
- Alimentation history(On day 21)
- Change in anxiety(on Day 2 and Day 19)
- Change in intestine integrity(on Day 2 and Day 19)
- Change in intestinal permeability(on Day 2 and Day 19)
- Intestinal permeability(On day 3)
- Change in work memory(on Day 2 and Day 19)
- Change in albumin, pre-albumin and zinc concentration(on Day 2 and Day 19)
- Change in alcohol craving(on Day 2 and Day 19)
- Change in impulsivity(on Day 2 and Day 19)