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

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757089
• Other study ID #: ALCOFILTRUM-NIR-B-07/2021
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: February 2023
• Source: AVVA Pharmaceuticals Ltd.
• Contact: Artemiy A. Sergeev, M.D., D.Sci.
• Phone: +74952690016
• Email: sergeev[@]rnd.avvapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Intoxication
• Alcoholic Intoxication

Intervention

Dietary Supplement:
• ALCOFILTRUM
ALCOFILTRUM helps alleviate alcohol hangover symptoms after a single intake for 30 minutes before alcohol consumption.

Locations

Country	Name	City	State
Belarus	Clinical Emergency Hospital	Minsk

Sponsors (1)

Lead Sponsor	Collaborator
AVVA Pharmaceuticals Ltd.

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Adverse Events [Safety and Tolerability]	Incidence rate of any adverse events.	5 days
Other	Incidence of Serious Adverse events [Safety and Tolerability]	Incidence rate of any serious adverse events.	5 days
Other	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
Other	Heart rate [Safety and Tolerability]	Hear rate 1; 2; 3, 4, 12, 13 hours vs. baseline.	13 hours
Primary	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	Schulte test	Attention focusing and work efficiency according to Schulte test. Measurement timepoints: baseline, 1, 4, 12, 13 hours.	13 hours
Secondary	Romberg Stance test	Coordination and stability assessment in Romberg Stances. Measurement coordination and stability timepoints: baseline, 1, 4, 12, 13 hours.	13 hours
Secondary	Mini Cog test	Psychoneurological status. Measurement timepoints: baseline, 1, 4, 12, 13 hours.	13 hours
Secondary	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
Secondary	Blood Alcohol level	Concentration of ethanol in per mille. Measurement timepoints: baseline, 1, 4, 12 hours.	12 hours
Secondary	Blood acetaldehyde level	Concentration of acetaldehyde in ng/mL. Measurement timepoints: baseline, 1, 4, 12 hours.	12 hours
Secondary	C-reactive protein level	Blood concentration of C-reactive protein in mg/L. Measurement timepoints: baseline, 4, 12 hours.	12 hours
Secondary	Bilirubin level	Blood concentrations of bilirubin and bilirubin fractions (direct and indirect) in umol/L. Measurement timepoints: baseline, 12 hours.	12 hours
Secondary	Blood Inflamatory markers	Concentrations of TNF-alpha and 8-isoprostane in pg/mL. Measurement timepoints: baseline, 4, 12 hours.	12 hours
Secondary	Liver enzyme markers	Blood concentrations of AST, ALT, ALP, GGT in u/L. Measurement timepoints: baseline, 12 hours.	12 hours