Sylimarin, Pyrroloquinoline, Quinone Sodium Salt and Myricetin Assumption Effects

NCT06548503 | Completed

• 1 other identifier: SiPiMi2123
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxidative Stress; Alcohol Drinking

Keywords

oxidative stress; alcohol

Outcome Measures

Primary Outcomes (9)

• 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.

Study Arms (2)

Intervention

EXPERIMENTAL

Subject assumed the Si.Pi.Mi product as detailed in the protocol

Dietary Supplement: Si.Pi.Mi product

Placebo

PLACEBO COMPARATOR

Subjects assumed the placebo as detailed in the protocol

Other: Placebo

Interventions

Si.Pi.Mi product DIETARY_SUPPLEMENT

Assumption of the product as detailed in the protocol

Intervention

Placebo OTHER

Assumption of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18 and 35 years;
• no history of alcohol abuse or other substances.
• Caucasian ethnicity.
• no smoker;
• good health condition, no autoimmune, endocrine, infectious, cardiac, renal, hepatic or metabolic diseases;
• no pregnancy or lactation condition.

You may not qualify if:

• pregnancy
• age falling outside limits
• smoke
• any disease

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Department of Biomedical Sciences

Padua, 35131, Italy

Location

Related Publications (1)

• Bosco G, Vezzoli A, Brizzolari A, Paganini M, Giacon TA, Savini F, Gussoni M, Montorsi M, Dellanoce C, Mrakic-Sposta S. Consumption of Sylimarin, Pyrroloquinoline Quinone Sodium Salt and Myricetin: Effects on Alcohol Levels and Markers of Oxidative Stress-A Pilot Study. Nutrients. 2024 Sep 3;16(17):2965. doi: 10.3390/nu16172965.

  PMID: 39275279 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: same taste, same case, just a letter on the external case.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two groups, one with placebo, one with the Si.Pi.Mi product

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 12, 2024
• Study Start: November 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)