Changes in body composition, substrate oxidation, and resting metabolic rate in adult celiac disease patients after a 1-y gluten-free diet treatment.
E Capristo, G Addolorato, G Mingrone...
https://pubmed.ncbi.nlm.nih.gov/10871564Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05530070
Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies
Led by University of Pecs · Updated on 2025-01-22
190
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the key cardiovascular risk factors, including metabolic parameters and body composition, in people with coeliac disease (CD). This research focuses on newly diagnosed and treated CD patients to understand how these factors change over time, especially during a gluten-free diet (GFD). The study also evaluates whether a structured dietary intervention can reduce negative effects associated with an unbalanced diet in these patients. The study includes a randomized controlled trial where participants are assigned either to a dietary intervention group receiving structured, group-based online dietary counseling focused on maintaining a GFD and adopting a Mediterranean diet, or to a standard care group receiving baseline dietary education. The counseling consists of six sessions over one year, with monthly meetings for five months and a final session at month nine. The study also collects detailed data on body composition and cardiovascular risk markers. Participants will undergo various assessments including body composition measurement, questionnaires on symptoms, quality of life, and diet adherence, blood tests for metabolic and immunological parameters, urine tests for gluten intake, and ultrasound scans to check for fatty liver disease. These evaluations occur over one year to monitor changes in percent body fat and other health markers. The study aims to improve understanding of metabolic and cardiovascular health in CD and to optimize follow-up care.
CONDITIONS
Brief Title
Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age should be over 18 years.
- Blood collection must be indicated with medical conditions.
- Signed informed consent.
- Diagnosis of coeliac disease according to current guidelines.
- Newly diagnosed patients must be on a gluten-containing diet.
- Patients on a gluten-free diet for at least one year must show good dietary adherence.
- In the randomized trial, strict dietary adherence is confirmed by specific tests and interviews.
- Adherence to the Mediterranean diet should be suboptimal (score ≤ 8).
- Patients in the randomized trial must have internet access and be able to attend online sessions for one year.
- Control subjects must be free from coeliac disease and on a gluten-containing diet.
You will not qualify if you...
- Estimated glomerular filtration rate <60 mL/min/1.73m2 (severe kidney failure).
- Liver cirrhosis in Child-Pugh class B-C.
- Heart failure classified as New York Heart Association III-IV.
- Active malignant diseases.
- Any acute illnesses or worsening of chronic conditions.
- Diseases causing clinically relevant malabsorption.
- Refractory coeliac disease.
- Pregnancy or lactation.
- Inability to understand the informed consent.
- Lack of consent or withdrawal of consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Randomized Trial Participation
Duration - 1 year
Participants are randomized to receive either structured, group-based online dietary counseling sessions or standard of care with baseline dietary education. The counseling aims to maintain a gluten-free diet and promote a healthy lifestyle aligned with the Mediterranean diet.
6 online group counseling sessions over 1 year (monthly for 5 months and one at month 9)
Assessment of Cardiovascular Risk and Metabolic Parameters
Duration - 1 year
Participants undergo anthropometric measurements, questionnaires, urine and blood collection, and ultrasound examinations to assess body composition, dietary adherence, cardiovascular risk factors, and liver health throughout the study.
Multiple assessments including questionnaires, blood and urine collection, and ultrasound at baseline and follow-up visits during the 1-year study
Trial Site Locations
Total: 1 location
1
First Department of Medicine, Medical School, University of Pécs
Pécs, Baranya, Hungary, 7624
Actively Recruiting
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Research Team
J
Judit Bajor, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Adherence to the gluten-free diet can achieve the therapeutic goals in almost all patients with coeliac disease: A 5-year longitudinal study from diagnosis.
Evan D Newnham, Susan J Shepherd, Boyd J Strauss...
https://pubmed.ncbi.nlm.nih.gov/26212198Impact of type 1 diabetes mellitus and celiac disease on nutrition and quality of life.
J G Nunes-Silva, V S Nunes, R P Schwartz...
https://pubmed.ncbi.nlm.nih.gov/28067892Changes in Age at Diagnosis and Nutritional Course of Celiac Disease in the Last Two Decades.
Mónica Villanueva, Amaya Oyarzún, Bárbara Leyton...
https://pubmed.ncbi.nlm.nih.gov/31935859Gluten-Free Diet: Gaps and Needs for a Healthier Diet.
Valentina Melini, Francesca Melini
https://pubmed.ncbi.nlm.nih.gov/30650530Anthropometric Parameters in Celiac Disease: A Review on the Different Evaluation Methods and Disease Effects.
Allysson Costa, Gleisson A P Brito
https://pubmed.ncbi.nlm.nih.gov/31583132Patients with coeliac disease are increasingly overweight or obese on presentation.
Elizabeth Tucker, Kamran Rostami, Sudhakaran Prabhakaran...
https://pubmed.ncbi.nlm.nih.gov/22457854Influence of nutrition education in paediatric coeliac disease: impact of the role of the registered dietitian: a prospective, single-arm intervention study.
M Suárez-González, C Bousoño García, S Jiménez Treviño...
https://pubmed.ncbi.nlm.nih.gov/32790023Multidimensional Disadvantages of a Gluten-Free Diet in Celiac Disease: A Narrative Review.
Martyna Marciniak, Aleksandra Szymczak-Tomczak, Dagmara Mahadea...
https://pubmed.ncbi.nlm.nih.gov/33669442Influence of a structured, 1-year-long dietary intervention regarding body composition and cardiovascular risk (ARCTIC) in coeliac disease: a protocol of a multicentre randomised controlled trial.
Zsófia Vereczkei, Zsolt Szakács, Míra Zsófia Peresztegi...
https://pubmed.ncbi.nlm.nih.gov/39384235