Dietary Assessment and Mycotoxin Exposure in Celiac Disease

Celiac Disease Clinical Trial

Official title:

Dietary Assessment and Mycotoxin Exposure in Celiac Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01975155
• Other study ID #: 852/12
• Secondary ID: GFD/2012
• Status: Recruiting
• Phase: N/A
• First received: October 23, 2013
• Last updated: August 26, 2015
• Start date: June 2013
• Est. completion date: July 2016

Study information

• Verified date: August 2015
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Leda Roncooni
• Phone: 0039 02 55033384
• Email: leda.roncoroni[@]tiscali.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Other:
• food questionnaire

• Urinary mycotoxin test

Locations

Country	Name	City	State
Italy	Celiac Disease Center, Fondazione IRCCS Cà Granda	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mycotoxins	Urinary measure of mycotoxins	mycotoxins will be measured at the end of a 7 day period and the completion of the dietary questionnaire	No
Secondary	dietary questionnaire	during a 7 days lonf period the patients will be invited to fill a complete dietary questionnaire on the basis of the questionnaire results the nutritional status will be evaluated At the end of these 7 days the patients will collect the 24h urine for mycotoxin dosage	7 days	No

External Links

•   Web of the Celiac diseases center