Alcohol Drinking, Alcohol Intoxication
Conditions
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.
Interventions
DIETARY_SUPPLEMENTALCOFILTRUM
ALCOFILTRUM helps alleviate alcohol hangover symptoms after a single intake for 30 minutes before alcohol consumption.
Sponsors
AVVA Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-item overall hangover severity rating | 13 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hangover Symptoms Questionnaire | 13 hours | 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. |
| C-reactive protein level | 12 hours | Blood concentration of C-reactive protein in mg/L. Measurement timepoints: baseline, 4, 12 hours. |
| Bilirubin level | 12 hours | Blood concentrations of bilirubin and bilirubin fractions (direct and indirect) in umol/L. Measurement timepoints: baseline, 12 hours. |
| Blood Inflamatory markers | 12 hours | Concentrations of TNF-alpha and 8-isoprostane in pg/mL. Measurement timepoints: baseline, 4, 12 hours. |
| Liver enzyme markers | 12 hours | Blood concentrations of AST, ALT, ALP, GGT in u/L. Measurement timepoints: baseline, 12 hours. |
| Romberg Stance test | 13 hours | Coordination and stability assessment in Romberg Stances. Measurement coordination and stability timepoints: baseline, 1, 4, 12, 13 hours. |
| Schulte test | 13 hours | Attention focusing and work efficiency according to Schulte test. Measurement timepoints: baseline, 1, 4, 12, 13 hours. |
| Mini Cog test | 13 hours | Psychoneurological status. Measurement timepoints: baseline, 1, 4, 12, 13 hours. |
| Blood Alcohol level | 12 hours | Concentration of ethanol in per mille. Measurement timepoints: baseline, 1, 4, 12 hours. |
| Blood acetaldehyde level | 12 hours | Concentration of acetaldehyde in ng/mL. Measurement timepoints: baseline, 1, 4, 12 hours. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Arterial blood pressure [Safety and Tolerability] | 13 hours | Level of systolic and diastolic arterial blood pressure 1; 2; 3, 4, 12, 13 hours vs. baseline. |
| Heart rate [Safety and Tolerability] | 13 hours | Hear rate 1; 2; 3, 4, 12, 13 hours vs. baseline. |
| Incidence of Serious Adverse events [Safety and Tolerability] | 5 days | Incidence rate of any serious adverse events. |
| Incidence of Adverse Events [Safety and Tolerability] | 5 days | Incidence rate of any adverse events. |
Countries
Belarus
Contacts
Primary ContactArtemiy A. Sergeev, M.D., D.Sci.
Outcome results
None listed