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Diverticular Disease (DD) is a frequent condition in Western populations and may be associated with complications including bleeding, perforation, acute diverticulitis, and colon strictures. Severity of diverticular disease and its association with prognosis in relation to surgery using the Diverticular Inflammation and Complication Assessment (DICA) classification has been validated in several studies. A sedentary lifestyle, poor fibre intake and other unhealthy dietary habits have been associated with DD. On the contrary, the Mediterranean Diet (MD), which involves factors such as consuming locally grown food products, family meals, conviviality, involvement in the preparation of meals, as well as high intake of vegetables, legumes, fruit and cereals, medium intake of fish, low intake of meat and saturated fat, high intake of unsaturated fat (particularly olive oil), a medium-low intake of dairy products (yogurt and cheese), and a moderate intake of wine, seems to protect against DD. Moreover, populations that follow the MD pattern show a 50% lower rate of cardiovascular mortality due to cardiovascular disease and show highest longevity. A common finding in clinical practice is that a majority of patients undergoing a new diet stop to correctly follow the diet in the long term, suggesting the importance of periodic counselling for patients.
The aim of the study is to evaluate the impact of MD on DD and on severity of DD, and to explore the impact of incorporating a dietitian-driven counselling program in this condition.
The investigators will verify whether a 12-week nutritional intervention is able to reduce DD-related symptoms, improve patient's quality of life and reduce the need for medication. DD severity will be assessed using DICA, MD adherence will be assessed with Medi-Lite (Mediterranean Literature scoring system), symptoms will be assessed with a VAS (visual analogue scale) questionnaire and IBS-SSS (the irritable bowel syndrome severity scoring system), nutritional status will be evaluated using BIA (bioelectrical impedance analysis) and metabolic blood parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary counselling on Mediterranean Diet | Experimental | Patients will be asked to follow the Mediterranean Diet and to participate to an educational program |
|
| Mediterranean Diet | Experimental | Patients will be asked to follow Mediterranean Diet only |
|
| Controls | No Intervention | Patients maintain their current lifestyle and dietary habits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional counselling | Other | Patients will be asked to follow the Mediterranean Diet and to participate to an educational program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission of symptoms | The percentage of patients that will achieve symptom-free remission of symptoms | 12 weeks |
| Adherence to diet | The effect of a counselling program on Medi-LITE score | 12 weeks |
| DICA and diet | The differences in response based on basal DICA (Diverticular Inflammation and Complication Assessment, value 1-3, with DICA 3 meaning a worse outcome). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation | To determine the percentage of patients with a reduction of fecal calprotectin | 12 weeks |
| Metabolism | The percentage of patients with a modification in blood metabolic parameters: liver and renal function, cholesterol, HDL, LDL, triglycerides, glucose, HOMA (homeostasis model assessment) index, albumin. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Ferronato, MD | UOSD Endoscopia - Ospedale Alto Vicentino - AULSS 7 Pedemontana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOSD Endoscopia - Ospedale Alto Vicentino - AULSS 7 Pedemontana | Santorso | Vicenza | 36014 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31930224 | Background | Tursi A, Brandimarte G, Di Mario F, Lanas A, Scarpignato C, Bafutto M, Barbara G, Bassotti G, Binda GA, Biondi A, Biondo S, Cassieri C, Crucitti A, Dumitrascu DL, Elisei W, Escalante R, Herszenyi L, Kruis W, Kupcinskas J, Lahat A, Lecca PG, Maconi G, Malfertheiner P, Mazzari A, Mearin F, Milosavljevic T, Nardone G, Chavez De Oliveira E, Papa A, Papagrigoriadis S, Pera M, Persiani R, Picchio M, Regula J, Stimac D, Stollman N, Strate LL, Walker MM; DICA International Group. The DICA Endoscopic Classification for Diverticular Disease of the Colon Shows a Significant Interobserver Agreement among Community Endoscopists: an International Study. J Gastrointestin Liver Dis. 2019 Dec 19;28(suppl. 4):39-44. doi: 10.15403/jgld-558. | |
| 34702716 |
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Individual participant data must be submitted to local Ethical Committee
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| ID | Term |
|---|---|
| D000076385 | Diverticular Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Diet | Other | Patients will be asked to follow Mediterranean Diet only |
|
| 12 weeks |
| Drug use | The percentage of patients with modifications in drug therapy. | 12 weeks |
| Background |
| Tursi A, Brandimarte G, Di Mario F, Elisei W, Picchio M, Allegretta L, Annunziata ML, Bafutto M, Bassotti G, Bianco MA, Colucci R, Conigliaro R, Dumitrascu D, Escalante R, Ferrini L, Forti G, Franceschi M, Graziani MG, Lammert F, Latella G, Maconi G, Nardone G, Camara de Castro Oliveira L, Chaves Oliveira E, Papa A, Papagrigoriadis S, Pietrzak A, Pontone S, Poskus T, Pranzo G, Reichert MC, Rodino S, Regula J, Scaccianoce G, Scaldaferri F, Vassallo R, Zampaletta C, Zullo A, Piovani D, Bonovas S, Danese S; DICA International Group. Prognostic performance of the 'DICA' endoscopic classification and the 'CODA' score in predicting clinical outcomes of diverticular disease: an international, multicentre, prospective cohort study. Gut. 2022 Jul;71(7):1350-1358. doi: 10.1136/gutjnl-2021-325574. Epub 2021 Oct 26. |
| 28276908 | Background | Sofi F, Dinu M, Pagliai G, Marcucci R, Casini A. Validation of a literature-based adherence score to Mediterranean diet: the MEDI-LITE score. Int J Food Sci Nutr. 2017 Sep;68(6):757-762. doi: 10.1080/09637486.2017.1287884. Epub 2017 Feb 9. |