Dietary Assessment and Mycotoxin Exposure in Celiac Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor:
Collaborator:
University of Parma
Information provided by (Responsible Party):
Leda Roncoroni, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT01975155
First received: October 23, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Celiac Disease
Other: food questionnaire
Other: Urinary mycotoxin test

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Dietary Assessment and Mycotoxin Exposure in Celiac Subjects

Resource links provided by NLM:


Further study details as provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:

Primary Outcome Measures:
  • Mycotoxins [ Time Frame: mycotoxins will be measured at the end of a 7 day period and the completion of the dietary questionnaire ] [ Designated as safety issue: No ]
    Urinary measure of mycotoxins


Secondary Outcome Measures:
  • dietary questionnaire [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples Without DNA

Urine


Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Celiac
patients with celiac disease filling the questionnaire and undergoing urinary test
Other: food questionnaire Other: Urinary mycotoxin test
healthy controls
healthy patients filling the questionnaire and undergoing urinary test
Other: food questionnaire Other: Urinary mycotoxin test

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

adult subjects with or without celiac disease

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975155

Contacts
Contact: Leda Roncooni 0039 02 55033384 leda.roncoroni@tiscali.it

Locations
Italy
Celiac Disease Center, Fondazione IRCCS Cà Granda Recruiting
Milano, Italy, 20122
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
University of Parma
Investigators
Study Chair: Luca Elli, MD Celiac Disease Center, Fondazione IRCCS Cà Granda
Study Chair: Nicoletta Pellegrini University of Parma
Study Chair: Dario Conte, MD Celiac Disease Center, Fondazione IRCCS Cà Granda
  More Information

Additional Information:
No publications provided

Responsible Party: Leda Roncoroni, Biologist, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT01975155     History of Changes
Other Study ID Numbers: 852/12, GFD/2012
Study First Received: October 23, 2013
Last Updated: October 28, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Celiac disease
Gluten free diet nutrient content
mycotoxins
Gluten free diet

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 19, 2014