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
Launched by FEDERICO II UNIVERSITY · Mar 19, 2025
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
A randomized, crossover, placebo-controlled study will be conducted. Twenty patients with type 2 diabetes mellitus (T2DM) recruited from the Diabetes Unit of the University Hospital of Naples "Federico II" who meet the inclusion criteria will be studied. After a 2-week run-in period during which they will stabilize their habitual diet, participants will be randomly assigned to receive either 150 ml/day of a polyphenol-rich red grape pomace beverage (RG) or 150 ml/day of a control beverage (Placebo) for a 6-week period each. The two treatments will be separated by a 2-week wash-out period.
...
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • Cardiovascular events (myocardial infarction and/or stroke)
- • 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
- • Insulin therapy and other hypoglycemic drugs other than metformin
- • Habitual intense physical activity
About Federico Ii University
Federico II University, located in Naples, Italy, is a prestigious academic institution with a strong emphasis on advanced research and clinical innovation. As a clinical trial sponsor, the university is committed to fostering the development of novel therapeutic interventions and enhancing patient care through rigorous scientific inquiry. With a multidisciplinary approach, Federico II University collaborates with healthcare professionals, researchers, and industry partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory requirements. Its dedication to improving health outcomes is reflected in its robust research programs and commitment to translating scientific findings into clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Napoli, , Italy
Patients applied
Trial Officials
Rosalba Giacco, Senior Researcher
Principal Investigator
CNR
Luigi Russo, Senior Researcher
Study Director
CNR
Lutgarda Bozzetto, Full Professor
Principal Investigator
Federico II Univerisity
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported