Sylimarin, Pyrroloquinoline, Quinone Sodium Salt and Myricetin Assumption Effects
NCT Number: NCT06548503
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oxidative Stress|Alcohol Drinking
Interventions: DIETARY_SUPPLEMENT: Si.Pi.Mi product|OTHER: Placebo
Sponsor: University of Padova
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-11-01
Completion Date: 2024-03-31
Locations: Department of Biomedical Sciences, Padova, 35131, Italy

Summary:
Alcohol abuse is one of the most common causes of mortality worldwide, also associated with increased oxidative stress and end-organ damage in chronic assumption.

This study intend to evaluate the effect of the intake of a product contain silymarin, pyrroloquinoline quinone sodium salt, and myricetin (conventionally for this project Si.Pi.Mi.) on alcohol, ethyl glucuronide (EtG) and markers of oxidative stress levels on regular wine assumption over a predefined time period.

Primary Outcome Measures: Change in Reactive oxygen species production, Reactive oxygen species production on blood and saliva (μmol/min) (by paramagnetic resonance), Blood and Saliva: Day 0 (baseline); Day 1 and 7: 60, 120 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo. On saliva alone: Day 2, Day 3, Day 4, Day 5, Day 6, in the morning.|Change in Total Antioxidant Capacity, Total antioxidant capacity on blood and saliva (by paramagnetic resonance) (mM), Blood and Saliva: Day 0 (baseline); Day 1 and 7: 60, 120 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo. On saliva alone: Day 2, Day 3, Day 4, Day 5, Day 6, in the morning.|Change in lipid peroxidation markers, Lipid peroxidation assessed by measuring 8-isoprostane and 8-OH deoxyguanosine concentration (by competitive immunoassay) (pg mg-1 creatinine), Day 1 and 7: at 0 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.|Change in nitrite and nitrate (NO2 and NO3) concentration, nitrite and nitrate (NO2 and NO3) concentration on urine (by colorimetry based on the Griess reaction (μM), Day 1 and 7: at 0 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.|Change in Co Q10 coenzyme levels, CoQ10 levels on blood (by competitive inhibition enzyme immunoassay) (μg/mL), Day 1 and 7: at 0 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.|Change in aminothiols levels, total (tot) and reduced (red) aminothiols on blood (by fluorescence spectroscopy) (μmol L-1), Day 1 and 7: 0, 60, 120 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.|Change in Renal damage markers, Renal damage by measuring on urine: creatinine (g-L-1), neopterin (μmol·mol-1 creatinine), and uric acid levels (mg/dl), (by isocratic high-pressure liquid chromatography), Day 1 and 7: at 0 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.|Change in Blood Alcohol Levels, Measurement of blood alcohol levels (g/L) (by isothermal elution), Day 1 and 7: 60, 120 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.|Change in Urine Ethyl Glucuronoide, Urine Ethyl Glucuronoide measurement on urine (ng/mL) (by enzymatic immunoassay), Day 1 and 7: at 0 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.