Dietary Assessment and Mycotoxin Exposure in Celiac Subjects
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mycotoxins
研究概览
简要总结
Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries. Gluten free diet is the only available therapy but few is known about its nutrient content and mycotoxin exposure.
详细描述
Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries, occurring in genetically susceptible individuals, elicited by the gluten ingestion. By definition the disease responds to gluten withdrawal, so currently gluten free (GFD) diet is the therapy for celiac patients. It is known that gluten rich products are important source of nutrients on the other hands it is not clear if gluten exclusion from the diet could have a negative effect on the nutritional status of CD patients.
Another concern related to the GFD could be the high exposure to mycotoxins due to the high concentration of maize in GF products.
AIM The aim of this study is to estimate the nutrient intake and the dietary exposure of all mycotoxin types in a group of treated celiac patients vs. non-celiac subjects.
METHODS We will enroll celiac patients and healthy controls. Exclusion criteria for celiac patients will be: 1) diagnosis of CD less than two years 2) age under 18 or over 70 3) associated metabolic or chronic disease 4) pregnancy or lactation 5) being vegetarian or vegan. Exclusion criteria for the healthy subjects will be the same with the exception of the diagnosis of CD.
Total food and beverage consumption will be assessed by means of a 7 days long questionnaire. All participants will be trained by a nutritionist to record all food consumed and the completed forms will be returned and reviewed during a face-to-face interview at which portions size were quantified in standard units. Participants will be asked to weigh all foods and drinks consumed and to provide a detailed description of each food, including methods of preparation and recipes, whenever possible. In case of Gluten Free Foods, patients will be asked to precisely note the name of the manufacturer or to provide the food label.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •celiac disease diagnosis
- •GFD for at least 2 years
排除标准
- •follow a vegetarian diet
- •being affected by important systemic or psychiatric disorders
- •incapacity to fill the questionnaires
结局指标
主要结局
Mycotoxins
时间窗: mycotoxins will be measured at the end of a 7 day period and the completion of the dietary questionnaire
Urinary measure of mycotoxins
次要结局
- dietary questionnaire(7 days)
研究者
Leda Roncoroni
Biologist
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
