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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 3, 2024

Primary Completion Date

August 8, 2025

Study Completion Date

October 31, 2025

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.

Trial Locations (1)

80131

Federico II University, Napoli

All Listed Sponsors
collaborator

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

OTHER_GOV

lead

Federico II University

OTHER