Effect of Nutritional Counseling and Mediterranean Diet on Patients With Diverticular Disease

NCT06797739 | Active Not Recruiting

• 1 other identifier: 18987/22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diverticular Diseases

Keywords

DICA endoscopic score; Medi-LITE score; Symptomatic Uncomplicated Diverticular Disease (SUDD)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Inflammation

  12 weeks

• Metabolism

  12 weeks

• Drug use

  12 weeks

Study Arms (3)

Dietary counselling on Mediterranean Diet

EXPERIMENTAL

Patients will be asked to follow the Mediterranean Diet and to participate to an educational program

Other: Nutritional counselling; Other: Diet

Mediterranean Diet

EXPERIMENTAL

Patients will be asked to follow Mediterranean Diet only

Other: Diet

Controls

NO INTERVENTION

Patients maintain their current lifestyle and dietary habits.

Interventions

Nutritional counselling OTHER

Patients will be asked to follow the Mediterranean Diet and to participate to an educational program.

Dietary counselling on Mediterranean Diet

Diet OTHER

Patients will be asked to follow Mediterranean Diet only

Dietary counselling on Mediterranean Diet; Mediterranean Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regione del Veneto - AULSS n. 7 Pedemontana: lead

Study Sites (1)

UOSD Endoscopia - Ospedale Alto Vicentino - AULSS 7 Pedemontana

Santorso, Vicenza, 36014, Italy

Location

Related Publications (3)

• 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.

  PMID: 31930224 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.

  PMID: 34702716 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.

  PMID: 28276908 BACKGROUND

MeSH Terms

Conditions

Diverticular Diseases

Interventions

Diet

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Antonio Ferronato, MD

  UOSD Endoscopia - Ospedale Alto Vicentino - AULSS 7 Pedemontana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: January 28, 2025
• Study Start: April 4, 2023
• Primary Completion: December 16, 2024
• Study Completion: April 4, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)