Influence 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
Introduction Coeliac disease (CD) affects 1% of the population worldwide. The only available evidence-based treatment is a strict gluten-free diet (GFD), which can readily lead to weight gain and unfavourable metabolic changes (eg, dyslipidaemia, fatty liver disease and insulin resistance) if follow...
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BMJ Publishing Group
2024-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/10/e084365.full |
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| author | Zsolt Szakács Nelli Farkas Judit Bajor Nándor Faluhelyi Krisztina Hagymási Zsófia Vereczkei Míra Zsófia Peresztegi Klára Lemes Sarolta Dakó Eszter Dakó Szilvia Lada Gábor Szekeres Gyula Pásztor Gabriella Pár Emese Mezősi |
| author_facet | Zsolt Szakács Nelli Farkas Judit Bajor Nándor Faluhelyi Krisztina Hagymási Zsófia Vereczkei Míra Zsófia Peresztegi Klára Lemes Sarolta Dakó Eszter Dakó Szilvia Lada Gábor Szekeres Gyula Pásztor Gabriella Pár Emese Mezősi |
| author_sort | Zsolt Szakács |
| collection | DOAJ |
| description | Introduction Coeliac disease (CD) affects 1% of the population worldwide. The only available evidence-based treatment is a strict gluten-free diet (GFD), which can readily lead to weight gain and unfavourable metabolic changes (eg, dyslipidaemia, fatty liver disease and insulin resistance) if followed without adequate dietary control. That can lead to increased cardiovascular risk (CV). We planned a randomised controlled trial to test the effect of a group-based, structured, 1-year, advanced dietary education, per the proposal of a Mediterranean diet vs standard of care, regarding the most relevant CV risk factors (eg, metabolic parameters and body composition) in CD patients.Methods and analysis Randomisation will occur after the baseline dietary education and interview in a 1:1 allocation ratio. Outcomes include anthropometric parameters (body composition analysis including weight, Body Mass Index, fat mass, per cent body fat, skeletal muscle mass, visceral fat area and total body water) and CV risk-related metabolic parameters (eg, lipid profile, homocysteine, fasting glucose, haemoglobin A1c, Homeostatic Model Assessment Index, metabolic hormones, waist circumference, blood pressure, liver function tests, liver steatosis rate and diet composition). In this study, we aim to draw attention to a new aspect regarding managing CD: dietary education can lead to a better quality of the GFD, thereby reducing the risk of potential metabolic and CV complications.Ethics and dissemination The study was approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (27521-5/2022/EÜIG). Findings will be disseminated at research conferences and in peer-reviewed journals.Trial registration number NCT05530070 |
| format | Article |
| id | doaj-art-c9a7b09be63f4d01948fb30beddda9bd |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-c9a7b09be63f4d01948fb30beddda9bd2025-08-20T02:12:49ZengBMJ Publishing GroupBMJ Open2044-60552024-10-01141010.1136/bmjopen-2024-084365Influence 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 trialZsolt Szakács0Nelli Farkas1Judit Bajor2Nándor Faluhelyi3Krisztina Hagymási4Zsófia Vereczkei5Míra Zsófia Peresztegi6Klára Lemes7Sarolta Dakó8Eszter Dakó9Szilvia Lada10Gábor Szekeres11Gyula Pásztor12Gabriella Pár13Emese Mezősi14First Department of Medicine, Medical Shcool, University of Pécs, Pécs, HungaryInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, HungaryFirst Department of Medicine, Medical Shcool, University of Pécs, Pécs, HungaryDepartment of Radiology, Medical School, University of Pécs, Pécs, HungaryDepartment of Surgery, Transplantation and Gastroenterology, Faculty of Medicine, Semmelweis University, Budapest, HungaryInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, HungaryMedical Shcool, University of Pécs, Pécs, HungaryDepartment of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, HungaryDepartment of Surgery, Transplantation and Gastroenterology, Faculty of Medicine, Semmelweis University, Budapest, HungaryDepartment of Surgery, Transplantation and Gastroenterology, Faculty of Medicine, Semmelweis University, Budapest, HungaryDepartment of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, HungaryDepartment of Radiology, Medical School, University of Pécs, Pécs, HungaryDepartment of Radiology, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, HungaryFirst Department of Medicine, Medical Shcool, University of Pécs, Pécs, HungaryFirst Department of Medicine, Medical Shcool, University of Pécs, Pécs, HungaryIntroduction Coeliac disease (CD) affects 1% of the population worldwide. The only available evidence-based treatment is a strict gluten-free diet (GFD), which can readily lead to weight gain and unfavourable metabolic changes (eg, dyslipidaemia, fatty liver disease and insulin resistance) if followed without adequate dietary control. That can lead to increased cardiovascular risk (CV). We planned a randomised controlled trial to test the effect of a group-based, structured, 1-year, advanced dietary education, per the proposal of a Mediterranean diet vs standard of care, regarding the most relevant CV risk factors (eg, metabolic parameters and body composition) in CD patients.Methods and analysis Randomisation will occur after the baseline dietary education and interview in a 1:1 allocation ratio. Outcomes include anthropometric parameters (body composition analysis including weight, Body Mass Index, fat mass, per cent body fat, skeletal muscle mass, visceral fat area and total body water) and CV risk-related metabolic parameters (eg, lipid profile, homocysteine, fasting glucose, haemoglobin A1c, Homeostatic Model Assessment Index, metabolic hormones, waist circumference, blood pressure, liver function tests, liver steatosis rate and diet composition). In this study, we aim to draw attention to a new aspect regarding managing CD: dietary education can lead to a better quality of the GFD, thereby reducing the risk of potential metabolic and CV complications.Ethics and dissemination The study was approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (27521-5/2022/EÜIG). Findings will be disseminated at research conferences and in peer-reviewed journals.Trial registration number NCT05530070https://bmjopen.bmj.com/content/14/10/e084365.full |
| spellingShingle | Zsolt Szakács Nelli Farkas Judit Bajor Nándor Faluhelyi Krisztina Hagymási Zsófia Vereczkei Míra Zsófia Peresztegi Klára Lemes Sarolta Dakó Eszter Dakó Szilvia Lada Gábor Szekeres Gyula Pásztor Gabriella Pár Emese Mezősi Influence 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 BMJ Open |
| title | Influence 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 |
| title_full | Influence 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 |
| title_fullStr | Influence 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 |
| title_full_unstemmed | Influence 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 |
| title_short | Influence 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 |
| title_sort | influence 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 |
| url | https://bmjopen.bmj.com/content/14/10/e084365.full |
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