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临床试验/NCT01975155
NCT01975155Unknown不适用

Dietary Assessment and Mycotoxin Exposure in Celiac Subjects

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年6月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leda Roncoroni

Biologist

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

研究点 (1)

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