Binge DrinkingPhase 1MeABDNCT06298318
Metabolic Changes in Healthy Subjects with Acute Binge Drink
A Phase 1 study testing Vodka and water in people with Binge Drinking and Liver Injury, run by Zhejiang Chinese Medical University at 1 site in China.
Trial summary
The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects. The main questions it aims to answer are: 1. If acute binge drinking could alleviate liver injury and hepatic steatosis. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Binge Drinking, Liver Injury, Hepatic Steatosis
- What is being tested?
- Vodka and water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2024to 18 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male aged 18-30 years;
- body mass index (BMI) ranging from 18.5 to 28 kg/m²;
- having prior experience with binge drinking or hangovers, as assessed using the Personal Assessment of Maximum Drinking Capacity Survey Questionnaire
Who cannot join
- with alcohol intolerance or alcohol dependence;
- with serious health conditions, such as liver, kidney, cardiovascular, or gastrointestinal diseases;
- vegetarians;
- smokers;
- with a history of drug use, including antihistamines, antihypertensives, antidiabetics, anxiolytics, and central nervous system depressants;
- who had used antibiotics within two weeks prior to the trial;
- who had consumed alcohol, alcoholic beverages or alcohol-containing foods within one week before the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Acute Binge Drink Intervention on Healthy Young Subjects: a Double-blinded, Randomized Trial
The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects. The main questions it aims to answer are:
- If acute binge drinking could alleviate liver injury and hepatic steatosis.
Read the detailed description
The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects. The main questions it aims to answer are:
- If acute binge drinking could alleviate liver injury and hepatic steatosis.
Participants will be randomized into two groups (n=40) and provided vodka (1 g/kg body weight) or an equal amount of non-alcoholic beverages with the same taste and colour but without alcohol, respectively. 15 minutes later, they are successively provided with the same breakfast. Venous blood samples were collected at 0h, 1h, 3h, 5h, 6h, 12h, and 24h from each subject, respectively.
- Conditions
- Binge Drinking, Liver Injury, Hepatic Steatosis
- Being tested
- Vodka, water
- Keywords
- Acute alcohol intake, Liver
- Medical subject headings
- Binge Drinking, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VodkaOther
BMI: if 18.5 ≤ BMI < 24.0, individuals received 1.0 g/kg body weight of vodka; if 24.0 ≤ BMI ≤ 28.0, individuals received 0.8 g/kg body weight of vodka.
waterOther
equal amount of non-alcoholic beverages with the same taste and colour but without alcohol
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | BMI: if 18.5 ≤ BMI < 24.0, individuals received 1.0 g/kg body weight of water; if 24.0 ≤ BMI ≤ 28.0, individuals received 0.8 g/kg body weight of water. Receives: Other: water |
| vodka group | Experimental | BMI: if 18.5 ≤ BMI < 24.0, individuals received 1.0 g/kg body weight of vodka; if 24.0 ≤ BMI ≤ 28.0, individuals received 0.8 g/kg body weight of vodka. Receives: Other: Vodka |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatic function change
Research blood hepatic function include:Alanine Aminotransferase in U/L;Aspartate Aminotransferase in U/L;Gamma-Glutamyltransferase in U/L;Alpha-Fucosidase in U/L;Alkaline Phosphatase in U/L;cholinesterase in U/L;Lactate Dehydrogenase Enzyme in U/LTBIL in μmol/L, direct bilirubin in μmol/L, indirect bilirubin in μmol/L, and total bile acid in μmol/L
Measured: day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours
Hepatic fibrosis change
Research blood hepatic fibrosis include:Hyaluronicacid in ng/mL;Laminin in ng/mL;type # in ng/mL;precollagen in ng/ mL;type # collagen in ng/mL;Fibronect in ng/mL
Measured: day1-2 of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours
Lipid metabolism change
Research blood Fat metabolism include:Triglycerides in mmol/L;HDL-Cholesterol in mmol/L;LDL--Cholesterol in mmol/ L;Apolipoprotein A in mmol/L;Apolipoprotein B in mmol/L;Lipoprotein(a) in mmol/L
Measured: day1-2 and of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours
Secondary outcomes (2)
Ethanol concentration
Ethanol concentration change in mg/dL of each set
Measured: day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours
Acetaldehyde concentration
Acetaldehyde concentration change in mg/dL of each set
Measured: day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start27 Apr 2024
- Primary completion19 Sep 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Binge DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- not involve drug or biologic products
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Chinese Medical University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Li Lab,MD, Zhejiang Chinese Medical University
- Investigators
- guiiqin sun, Study chair, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298318
- Sponsor's protocol ID
- Acute Binge Drink
- Other IDs
- NSFC: 82273625, ZCLY24H2602, 202410344043, 202410344075X
- Acronym
- MeABD
- Status last verified
- Jan 2025
- First submitted
- 1 Nov 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protect volunteers' personal health data and personal privacy
Publications
Lee MH, Kwak JH, Jeon G, Lee JW, Seo JH, Lee HS, Lee JH. Red ginseng relieves the effects of alcohol consumption and hangover symptoms in healthy men: a randomized crossover study. Food Funct. 2014 Mar;5(3):528-34. doi: 10.1039/c3fo60481k.
PubMed 24458173Kim H, Kim YJ, Jeong HY, Kim JY, Choi EK, Chae SW, Kwon O. A standardized extract of the fruit of Hovenia dulcis alleviated alcohol-induced hangover in healthy subjects with heterozygous ALDH2: A randomized, controlled, crossover trial. J Ethnopharmacol. 2017 Sep 14;209:167-174. doi: 10.1016/j.jep.2017.07.028. Epub 2017 Jul 24.
PubMed 28750942
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Binge Drink Intervention on Healthy Young Subjects: a Double-blinded, Randomized Trial
- ClinicalTrials.gov ID
- NCT06298318
- Acronym / sponsor ID
- MeABD / Acute Binge Drink
- Conditions
- Binge Drinking, Liver Injury, Hepatic Steatosis
- Keywords
- Acute alcohol intake, Liver
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zhejiang Chinese Medical UniversityOther government
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects. The main questions it aims to answer are:
- If acute binge drinking could alleviate liver injury and hepatic steatosis.
Detailed description
The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects. The main questions it aims to answer are:
- If acute binge drinking could alleviate liver injury and hepatic steatosis.
Participants will be randomized into two groups (n=40) and provided vodka (1 g/kg body weight) or an equal amount of non-alcoholic beverages with the same taste and colour but without alcohol, respectively. 15 minutes later, they are successively provided with the same breakfast. Venous blood samples were collected at 0h, 1h, 3h, 5h, 6h, 12h, and 24h from each subject, respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- not involve drug or biologic products
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: waterBMI: if 18.5 ≤ BMI < 24.0, individuals received 1.0 g/kg body weight of water; if 24.0 ≤ BMI ≤ 28.0, individuals received 0.8 g/kg body weight of water. |
| vodka group | Experimental | Other: VodkaBMI: if 18.5 ≤ BMI < 24.0, individuals received 1.0 g/kg body weight of vodka; if 24.0 ≤ BMI ≤ 28.0, individuals received 0.8 g/kg body weight of vodka. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male aged 18-30 years;
- body mass index (BMI) ranging from 18.5 to 28 kg/m²;
- having prior experience with binge drinking or hangovers, as assessed using the Personal Assessment of Maximum Drinking Capacity Survey Questionnaire
Key exclusion criteria (7 listed)
- with alcohol intolerance or alcohol dependence;
- with serious health conditions, such as liver, kidney, cardiovascular, or gastrointestinal diseases;
- vegetarians;
- smokers;
- with a history of drug use, including antihistamines, antihypertensives, antidiabetics, anxiolytics, and central nervous system depressants;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VodkaBMI: if 18.5 ≤ BMI < 24.0, individuals received 1.0 g/kg body weight of vodka; if 24.0 ≤ BMI ≤ 28.0, individuals received 0.8 g/kg body weight of vodka. | Other | vodka group |
| waterequal amount of non-alcoholic beverages with the same taste and colour but without alcohol | Other | Control group |
Primary outcome
hepatic function change
Time frame: day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours
Research blood hepatic function include:Alanine Aminotransferase in U/L;Aspartate Aminotransferase in U/L;Gamma-Glutamyltransferase in U/L;Alpha-Fucosidase in U/L;Alkaline Phosphatase in U/L;cholinesterase in U/L;Lactate Dehydrogenase Enzyme in U/LTBIL in μmol/L, direct bilirubin in μmol/L, indirect bilirubin in μmol/L, and total bile acid in μmol/L
Hepatic fibrosis change
Time frame: day1-2 of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours
Research blood hepatic fibrosis include:Hyaluronicacid in ng/mL;Laminin in ng/mL;type # in ng/mL;precollagen in ng/ mL;type # collagen in ng/mL;Fibronect in ng/mL
Lipid metabolism change
Time frame: day1-2 and of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours
Research blood Fat metabolism include:Triglycerides in mmol/L;HDL-Cholesterol in mmol/L;LDL--Cholesterol in mmol/ L;Apolipoprotein A in mmol/L;Apolipoprotein B in mmol/L;Lipoprotein(a) in mmol/L
2 secondary outcomes
Ethanol concentration
Time frame: day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours
Acetaldehyde concentration
Time frame: day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Background: PubMed 24458173Lee MH, Kwak JH, Jeon G, Lee JW, Seo JH, Lee HS, Lee JH. Red ginseng relieves the effects of alcohol consumption and hangover symptoms in healthy men: a randomized crossover study. Food Funct. 2014 Mar;5(3):528-34. doi: 10.1039/c3fo60481k.
- Background: PubMed 28750942Kim H, Kim YJ, Jeong HY, Kim JY, Choi EK, Chae SW, Kwon O. A standardized extract of the fruit of Hovenia dulcis alleviated alcohol-induced hangover in healthy subjects with heterozygous ALDH2: A randomized, controlled, crossover trial. J Ethnopharmacol. 2017 Sep 14;209:167-174. doi: 10.1016/j.jep.2017.07.028. Epub 2017 Jul 24.
- Individual participant dataSharing planned: No. Protect volunteers' personal health data and personal privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
guiiqin sun study chair
Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vodka and water in people with Binge Drinking and Liver Injury, run by Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hepatic function change (time frame: day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06298318, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.