Active — Not RecruitingNot Applicable

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

Italy80 participantsStarted 2023-04-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 interven…

What they're measuring

Remission of symptoms

Timeframe: 12 weeks

Adherence to diet

Timeframe: 12 weeks

DICA and diet

Timeframe: 12 weeks

Trial details

NCT IDNCT06797739

SponsorRegione del Veneto - AULSS n. 7 Pedemontana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-16

View on ClinicalTrials.gov More Diverticular Diseases trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.