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NCT Number: NCT06797739

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diverticular Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UOSD Endoscopia - Ospedale Alto Vicentino - AULSS 7 Pedemontana

Santorso, Vicenza, 36014, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional Counselling

Other

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

Diet

Other

Patients will be asked to follow Mediterranean Diet only

Primary outcomes

  1. Remission of symptoms

    Time frame: 12 weeks

    The percentage of patients that will achieve symptom-free remission of symptoms

  2. Adherence to diet

    Time frame: 12 weeks

    The effect of a counselling program on Medi-LITE score

  3. DICA and diet

    Time frame: 12 weeks

    The differences in response based on basal DICA (Diverticular Inflammation and Complication Assessment, value 1-3, with DICA 3 meaning a worse outcome).

Secondary outcomes

  1. Inflammation

    Time frame: 12 weeks

    To determine the percentage of patients with a reduction of fecal calprotectin

  2. Metabolism

    Time frame: 12 weeks

    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.

  3. Drug use

    Time frame: 12 weeks

    The percentage of patients with modifications in drug therapy.

Sponsors and collaborators

Lead sponsor

Regione del Veneto - AULSS n. 7 Pedemontana

Other

Registry information

Official study title

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

Acronym: Nutri-DICA

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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