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

NCT ID: NCT05757089

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2023-05-30

Brief 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.

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.

Conditions

Alcohol Drinking; Alcohol Intoxication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ALCOFILTRUM

Intervention Type: DIETARY_SUPPLEMENT

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

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ALCOFILTRUM

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

AVVA Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olga A. Sharapova, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

City Clinical Emergency Hospital

Locations

Clinical Emergency Hospital

Minsk, , Belarus

Site Status: RECRUITING

Countries

Belarus

Central Contacts

Artemiy A. Sergeev, M.D., D.Sci.

Role: CONTACT

sergeev@rnd.avvapharma.com

+74952690016 ext. 3017

Facility Contacts

Olga А. Sharapova, Ph.D.

Role: primary

minsk.bsmp@gmail.com

+375172870001

Other Identifiers

ALCOFILTRUM-NIR-B-07/2021

Identifier Type: -

Identifier Source: org_study_id