Effect of Nutritional Counseling and Mediterranean Diet on Patients with Diverticular Disease (Nutri-DICA)

Effect of Nutritional Counseling and Mediterranean Diet on Patients with Diverticular Disease Evaluated Using the DICA Endoscopic Classification

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diverticular Diseases
• Intervention / Treatment: Other: Nutritional counselling; Other: Diet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Vicenza
    • Santorso, Vicenza, Italy, 36014
      • UOSD Endoscopia - Ospedale Alto Vicentino - AULSS 7 Pedemontana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have given written informed consent to participate
• Diagnosis of SUDD defined as the presence of symptoms (mainly abdominal pain, but also constipation, diarrhea and bloating) in patients with a previous diagnosis of diverticular disease at colonoscopy in the absence of any current complications (stenoses, abscesses, fistulas)
• DICA assessment during a colonoscopy

Exclusion Criteria:

• Acute or complicated diverticulitis
• Hospitalized patients
• Patients with active oncological diseases.
• Former partial or total colonic resection or other surgical procedures for DD
• Short bowel syndrome or active perianal fistulas
• Female patients who are pregnant or breastfeeding
• Patients with known malabsorption diseases (e.g. celiac disease)
• Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety
• Any surgical procedure requiring general anesthesia within 30 days prior to enrollment or is planning to undergo major surgery during the study period
• Patients undergoing a specific diet (e.g. diet for diabetics)
• Patients with known and well-established food allergies or intolerance to dietary elements of MD
• Patients with recent diagnosis of or non-controlled lactose intolerance
• Active participation in other interventional or drug research projects in the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary counselling on Mediterranean Diet; Patients will be asked to follow the Mediterranean Diet and to participate to an educational program	Other: Nutritional counselling; Patients will be asked to follow the Mediterranean Diet and to participate to an educational program.; Other: Diet; Patients will be asked to follow Mediterranean Diet only
Experimental: Mediterranean Diet; Patients will be asked to follow Mediterranean Diet only	Other: Diet; Patients will be asked to follow Mediterranean Diet only
No Intervention: Controls; Patients maintain their current lifestyle and dietary habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	12 weeks
Drug use	The percentage of patients with modifications in drug therapy.	12 weeks

Collaborators and Investigators

• Sponsor: Regione del Veneto - AULSS n. 7 Pedemontana
• Investigators: Principal Investigator: Antonio Ferronato, MD, UOSD Endoscopia - Ospedale Alto Vicentino - AULSS 7 Pedemontana

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Actual): December 16, 2024
• Study Completion (Estimated): April 4, 2025

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: DICA endoscopic score; Medi-LITE score; Symptomatic Uncomplicated Diverticular Disease (SUDD)
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Diverticulum
• Other Study ID Numbers: 18987/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data must be submitted to local Ethical Committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No