Clinical trial NCT05757089: Efficacy of the Dietary Food Supplement ALCOFILTRUM in Alleviating Alcohol Hangover Symptoms
Official title: An Open-label, Randomized, Cross-over, Comparative Study of ALCOFILTRUM Dietary Food Supplement for Alleviating Alcohol Hangover Symptoms in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Drinking
Alcohol Intoxication
Lead sponsor: AVVA Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-07
Enrollment: 60
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: 1-item overall hangover severity rating
timeFrame: 13 hours
Secondary outcomes:
measure: Schulte test
timeFrame: 13 hours
measure: Romberg Stance test
timeFrame: 13 hours
measure: Mini Cog test
timeFrame: 13 hours
measure: Hangover Symptoms Questionnaire
timeFrame: 13 hours
measure: Blood Alcohol level
timeFrame: 12 hours
measure: Blood acetaldehyde level
timeFrame: 12 hours
measure: C-reactive protein level
timeFrame: 12 hours
measure: Bilirubin level
timeFrame: 12 hours
measure: Blood Inflamatory markers
timeFrame: 12 hours
measure: Liver enzyme markers
timeFrame: 12 hours
Other outcomes:
measure: Incidence of Adverse Events [Safety and Tolerability]
timeFrame: 5 days
measure: Incidence of Serious Adverse events [Safety and Tolerability]
timeFrame: 5 days
measure: Arterial blood pressure [Safety and Tolerability]
timeFrame: 13 hours
measure: Heart rate [Safety and Tolerability]
timeFrame: 13 hours
Locations:
city: Minsk
country: Belarus
facility: Clinical Emergency Hospital
Study officials:
affiliation: City Clinical Emergency Hospital
name: Olga A. Sharapova, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: