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

Summary

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.

Conditions

• Diabetes Mellitus Type 2

Interventions

DIETARY_SUPPLEMENT

Supplementation with Polyphenol Rich Drink

Participants were instructed to consume, over a 6-week period, within the context of a Mediterranean diet, a polyphenol-rich drink RGPD (150 mL) containing 1.5 g of polyphenols. After this treatment period, participants underwent a two-week washout period before switching to the alternative treatment with control drink (Placebo) devoid of polyphenols. To evaluate metabolic responses during both fasting and postprandial states, participants participants consumed a standardized test meal at the end of the 6 weeks. This standard meal was preceded by the consumption of the RGPD 60 minutes prior.

DIETARY_SUPPLEMENT

Supplementation with Control Drink (Placebo)

Participants were instructed to consume, over a 6-week period, within the context of a Mediterranean diet, a control drink (Placebo) (150 mL) containing 0 g of polyphenols. After this treatment period, participants underwent a two-week washout period before switching to the alternative treatment with a polyphenol-rich drink RGPD (150 mL) containing 1.5 g of polyphenols. To evaluate metabolic responses during both fasting and postprandial states, participants participants consumed a standardized test meal at the end of the 6 weeks. This standard meal was preceded by the consumption of the Control drink (Placebo) 60 minutes prior.

Sponsors & Collaborators

• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

  collaborator OTHER_GOV

• Federico II University

  lead OTHER

Principal Investigators

• Rosalba Giacco, Senior Researcher · CNR

• Luigi Russo, Senior Researcher · CNR

• Lutgarda Bozzetto, Full Professor · Federico II Univerisity

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

35 Years

Max Age

70 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-03

Primary Completion

2025-08-08

Completion

2025-10-31

Countries

• Italy

Study Locations