Efficacy of the Dietary Food Supplement ALCOFILTRUM in Alleviating Alcohol Hangover Symptoms

An Open-label, Randomized, Cross-over, Comparative Study of ALCOFILTRUM Dietary Food Supplement for Alleviating Alcohol Hangover Symptoms in Healthy Volunteers

The aim of this open-label, randomized, crossover, comparative pilot study is to assess efficacy and safety of the dietary food supplement ALCOFILTRUM in healthy volunteers who consume alcohol. Specifically the study will evaluate:

• Efficacy of the intervention to alleviate hangover symptoms in participants who consumed alcohol,
• Safety of intervention in participants who consuming alcohol.

Participants will take four tablets of ALCOFILTRUM dietary food supplement 30 minutes before alcohol ingestion, while the control group will intake only alcohol drink.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Drinking; Alcohol Intoxication
• Intervention / Treatment: Dietary supplement: ALCOFILTRUM

Detailed Description

Heavy drinking of alcoholic beverages may lead to hangover, characterized by a combination of unpleasant physical and mental symptoms that affect mood, cognition, and physical functioning. Hangover symptoms begin within several hours following drinking cessation, when a person's blood alcohol concentration (BAC) is falling, and peak when BAC is zero. The symptoms may continue for up to 24 hours thereafter. Multiple contributing factors are responsible for the development of alcohol hangover symptoms which include ethanol itself, its metabolites and congeners / fusel alcohols. The liver plays a key role in alcohol detoxification, and is therefore affected the most. Drinking large amounts of alcohol can lead to significant damage to the liver and brain cells, the reason for the need for protection.

In this open-label, randomized, cross-over, comparative pilot study investigators aim to assess efficacy and safety of the dietary food supplement ALCOFILTRUM in healthy volunteers who consume alcohol. Participants will consume an alcoholic drink (Bulbash Nano Original vodka 40%) in a dose calculated for every study subject based on ethanol 1.7g/kg body weight. The test group will take 4 tablets of ALCOFILTRUM dietary food supplement, 30 minutes before alcohol ingestion, while the control group will intake only alcohol drink. Twelve to thirteen hours after the last alcohol intake hangover symptoms will be evaluated based on questionnaires, and measurements of balance / coordination, attention and blood parameters. The findings from this study will provide important insight of a possible intervention for alleviating alcohol hangover symptoms.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Artemiy A. Sergeev, M.D., D.Sci.; Phone Number: 3017 +74952690016; Email: sergeev@rnd.avvapharma.com

Study Locations

• Belarus
  • Minsk, Belarus, 220024
    • Recruiting
    • Clinical Emergency Hospital
    • Contact: Olga А. Sharapova, Ph.D.; Phone Number: +375172870001; Email: minsk.bsmp@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy men aged from 25 to 45 years inclusive.
• Body weight index of 18.5 to 30 kg/m2, with body weight of 60 kg to 100 kg.
• Healthy volunteers should behave adequately, with coherent speech observed.
• Available written Informed Consent for participation in this Study given by a healthy volunteer according to the effective laws.
• Subjects with history of episodic intake of alcohol and episodic hangover symptoms.
• Verified diagnosis "healthy": no chronic diseases in the history, no abnormal findings of lab tests and clinical investigations.

Exclusion Criteria:

• The Investigator's decision that a healthy volunteer is to be excluded in the interests of the volunteer.
• Any serious adverse event occurring to a healthy volunteer and associated with intake of alcohol and/or the study product.
• A healthy volunteer refusing to collaborate with the Medical Investigator or not complying with the Study procedure.
• A healthy volunteer was enrolled into the Study with violation of the Clinical Study Protocol.
• Any adverse events occurring to a healthy volunteer that, in a Medical Investigator's opinion, may endanger safety of a volunteer.
• Positive urine opioid test.
• Positive COVID-19 Ag Rapid Test.
• Positive blood alcohol test judging by concentration of alcohol fumes in exhaled air.
• 0.15 mg/L or higher content of alcohol fumes in exhaled air at the Screening Visit and at Visits 2, 3 prior to intake the first alcohol portion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: ALCOFILTRUM; ALCOFILTRUM, 4 tablets in a single dose, 30 minutes prior to consumption of alcohol. Ingredients per tablet: Lignin hydrolyzed 800 mg; Glycine 150 mg; Dihydromyricetin 30 mg; Vitamin B1 30 mg.	Dietary supplement: ALCOFILTRUM; ALCOFILTRUM helps alleviate alcohol hangover symptoms after a single intake for 30 minutes before alcohol consumption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-item overall hangover severity rating	Intensity of hangover symptoms in 12-13 hours after alcohol intake according to 1-item overall hangover severity rating. Score range is from 0 to 10, where higher scores mean more severe hangover symptoms.	13 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schulte test	Attention focusing and work efficiency according to Schulte test. Measurement timepoints: baseline, 1, 4, 12, 13 hours.	13 hours
Romberg Stance test	Coordination and stability assessment in Romberg Stances. Measurement coordination and stability timepoints: baseline, 1, 4, 12, 13 hours.	13 hours
Mini Cog test	Psychoneurological status. Measurement timepoints: baseline, 1, 4, 12, 13 hours.	13 hours
Hangover Symptoms Questionnaire	Score of Hangover Symptoms Questionnaire and frequency of hangover symptoms. Score rating from 0 to 4 for 24 diferent symptoms, where higher scores mean higher severity of the symptoms. Measurement timepoints: baseline, 1, 4, 12, 13 hours.	13 hours
Blood Alcohol level	Concentration of ethanol in per mille. Measurement timepoints: baseline, 1, 4, 12 hours.	12 hours
Blood acetaldehyde level	Concentration of acetaldehyde in ng/mL. Measurement timepoints: baseline, 1, 4, 12 hours.	12 hours
C-reactive protein level	Blood concentration of C-reactive protein in mg/L. Measurement timepoints: baseline, 4, 12 hours.	12 hours
Bilirubin level	Blood concentrations of bilirubin and bilirubin fractions (direct and indirect) in umol/L. Measurement timepoints: baseline, 12 hours.	12 hours
Blood Inflamatory markers	Concentrations of TNF-alpha and 8-isoprostane in pg/mL. Measurement timepoints: baseline, 4, 12 hours.	12 hours
Liver enzyme markers	Blood concentrations of AST, ALT, ALP, GGT in u/L. Measurement timepoints: baseline, 12 hours.	12 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events [Safety and Tolerability]	Incidence rate of any adverse events.	5 days
Incidence of Serious Adverse events [Safety and Tolerability]	Incidence rate of any serious adverse events.	5 days
Arterial blood pressure [Safety and Tolerability]	Level of systolic and diastolic arterial blood pressure 1; 2; 3, 4, 12, 13 hours vs. baseline.	13 hours
Heart rate [Safety and Tolerability]	Hear rate 1; 2; 3, 4, 12, 13 hours vs. baseline.	13 hours

Collaborators and Investigators

• Sponsor: AVVA Pharmaceuticals Ltd.
• Investigators: Principal Investigator: Olga A. Sharapova, Ph.D., City Clinical Emergency Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Anticipated): March 30, 2023
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Estimate): March 7, 2023

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholic Intoxication
• Other Study ID Numbers: ALCOFILTRUM-NIR-B-07/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No