NCT06895018Enrolling by invitation
Medium-term Effects of a Polyphenol-rich Beverage Based on Red Grape Pomace Extract on Non-alcoholic Fatty Liver Disease, Cardiometabolic Risk Profile and Gut Microbiota in Subjects with Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 26 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Nonalcoholic fatty liver disease (NAFLD) is a liver disease characterized by an abnormal accumulation of fat not due to alcohol or drug consumption that can evolve into steatohepatitis (NASH), fibrosis and cirrhosis. Its prevalence is high, affecting approximately 20-30% of the general adult population and is also growing in pediatric age. Obesity, insulin resistance and type 2 diabetes (T2DM) are common and well-known risk factors for NAFLD, which is approximately 2-3 times more prevalent among obese and diabetic individuals. Despite the high and increasing prevalence of NAFLD in the population, its pathophysiology is not fully understood and there is currently no pharmacological treatment available. Recent evidence suggests that dietary polyphenols may have specific beneficial effects on hepatic steatosis and associated sequelae by polyphenol metabolites and their phase II derivatives. Therefore, the aim of our study is to evaluate whether medium-term consumption of a beverage rich in polyphenols extracted from red grape pomace is able to exert beneficial effects on hepatic steatosis, cardiometabolic risk profile and microbiota composition of patients with type 2 diabetes.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 19 Mar 2025
- Start date
- 3 May 2024
- Primary completion date
- 8 Aug 2025
- Lead sponsor
- Federico II University
- NCT number
- NCT06895018
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 3 May 2024 to the primary completion date, 8 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Insulin therapy and other hypoglycemic drugs other than metformin
Other illness
- Cardiovascular events (myocardial infarction and/or stroke)
Lab values
- Renal insufficiency (serum creatinine \>1.5 mg/dl) and liver failure (ALT/AST twice the normal values)
- Anemia (Hb \<12 g/dl) or other chronic disease
Other
- Habitual intense physical activity
Who the study is looking for
- Body Mass Index (BMI) \>25 and ≤35 kg/m2
- Cholesterolemia ≤ 250 mg/dl and Triglyceridemia ≤ 200 mg/dl.
- type 2 Diabetes in good glycemic control (Hb1Ac ≤7.5%) treated with diet alone or diet + metformin.
Age in the registry: 35 years to 70 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Federico II University Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.