An interventional study of Nutritional counselling and Diet in Diverticular Diseases, sponsored by Regione del Veneto - AULSS n. 7 Pedemontana. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Regione del Veneto - AULSS n. 7 Pedemontana · Not applicable, Interventional, and Treatment
Among 11 studies in Diverticular Diseases with a site in Italy — 2 open to participants now, 3 under way, none of them phase 3. Diverticular Diseases · Italy.
Among the 11 studies in Diverticular Diseases with a site in Italy, this one is one of 5 that started in 2023, is one of 3 with no phase, and was the 8th registered.
44 studies on the registry are indexed under Diverticular Diseases; 9 are open to participants now.
This study's planned enrollment of 80 is close to the median of 81 across 31 interventional studies indexed under Diverticular Diseases.
Browse Diverticular Diseases studies →2 of the 11 studies in Diverticular Diseases with a site in Italy are open now, in 1 country. Each count lists the studies.
Of the 6 Diverticular Diseases studies recruiting now, 4 (67%) set no upper age limit and 1 (17%) stop at 75 or younger; 0 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 5 started in 2023.
Median enrollment 80 across the 7 interventional studies, 250 across the 4 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
1 of 11 have an industry lead sponsor. The 10 most frequent:
Regione del Veneto - AULSS n. 7 Pedemontana is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Regione del Veneto - AULSS n. 7 Pedemontana has 1 study filed under Diverticular Diseases — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Diverticular Diseases with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be asked to follow the Mediterranean Diet and to participate to an educational program
Other: Nutritional counselling · Other: Diet
Patients will be asked to follow Mediterranean Diet only
Other: Diet
Patients maintain their current lifestyle and dietary habits.
Patients will be asked to follow the Mediterranean Diet and to participate to an educational program.
Patients will be asked to follow Mediterranean Diet only
Remission of symptoms
The percentage of patients that will achieve symptom-free remission of symptoms
Time frame: 12 weeks
Adherence to diet
The effect of a counselling program on Medi-LITE score
Time frame: 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).
Time frame: 12 weeks
Inflammation
To determine the percentage of patients with a reduction of fecal calprotectin
Time frame: 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.
Time frame: 12 weeks
Drug use
The percentage of patients with modifications in drug therapy.
Time frame: 12 weeks
Plan to share: No — Individual participant data must be submitted to local Ethical Committee
Ran from Apr 2023 to primary completion in Dec 2024, 20 months.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Regione del Veneto - AULSS n. 7 Pedemontana