Clinical trial NCT01975155: Dietary Assessment and Mycotoxin Exposure in Celiac Disease
Official title: Dietary Assessment and Mycotoxin Exposure in Celiac Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Celiac Disease
Keywords: Celiac disease
Gluten free diet nutrient content
mycotoxins
Gluten free diet
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: University of Parma
First posted: 2013-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult subjects with or without celiac disease

Brief summary: 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.

Detailed description: 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.

The nutrient intake was calculated using a software application linked to the food database of the European Institute of Oncology integrated with the nutrient composition of 60 commercial GF foods. The computer output will consist in the evaluation of the mean daily intake of macro nutrients for each subject, in terms of carbohydrates, protein and lipid. Food items consumed will be also collapsed into food categories; pasta, bread, potatoes, flours, different cereals, fruit, vegetables, milk, cheese, eggs, fish, oils and fats, biscuits, sweet snacks, breakfast cereals, candies, chocolate, soft drinks, juices, coffees, teas, alcoholic beverages. For each subject, the mean daily intake of each food category will be calculated.

The 24-h urines were collected at the end of the registration period and analyzed for mycotoxins.

Eligibility criteria: Inclusion Criteria:

* celiac disease diagnosis
* GFD for at least 2 years

Exclusion Criteria:

* follow a vegetarian diet
* being affected by important systemic or psychiatric disorders
* incapacity to fill the questionnaires

Primary outcomes:
measure: Mycotoxins
timeFrame: mycotoxins will be measured at the end of a 7 day period and the completion of the dietary questionnaire
Secondary outcomes:
measure: dietary questionnaire
timeFrame: 7 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Celiac Disease Center, Fondazione IRCCS Cà Granda
Study officials:
affiliation: Celiac Disease Center, Fondazione IRCCS Cà Granda
name: Luca Elli, MD
role: STUDY_CHAIR
affiliation: University of Parma
name: Nicoletta Pellegrini
role: STUDY_CHAIR
affiliation: Celiac Disease Center, Fondazione IRCCS Cà Granda
name: Dario Conte, MD
role: STUDY_CHAIR
References:
citation: Morreale F, Agnoli C, Roncoroni L, Sieri S, Lombardo V, Mazzeo T, Elli L, Bardella MT, Agostoni C, Doneda L, Scricciolo A, Brighenti F, Pellegrini N. Are the dietary habits of treated individuals with celiac disease adherent to a Mediterranean diet? Nutr Metab Cardiovasc Dis. 2018 Nov;28(11):1148-1154. doi: 10.1016/j.numecd.2018.06.021. Epub 2018 Jul 4.
citation: Mazzeo T, Roncoroni L, Lombardo V, Tomba C, Elli L, Sieri S, Grioni S, Bardella MT, Agostoni C, Doneda L, Brighenti F, Pellegrini N. Evaluation of a Modified Italian European Prospective Investigation into Cancer and Nutrition Food Frequency Questionnaire for Individuals with Celiac Disease. J Acad Nutr Diet. 2016 Nov;116(11):1810-1816. doi: 10.1016/j.jand.2016.04.013. Epub 2016 May 28.