Binge DrinkingPhase 1/2NMN-MeABDNCT05882214

Metabolic Changes Induced by NMN in Healthy Subjects With Acute Binge Drink

A Phase 1/2 study testing β-nicotinamide Mononucleotide and Maltodextrin in people with Binge Drinking and Liver Injury, run by Zhejiang Chinese Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this double-blinded, randomized, crossover trial is to investigate the effects of NMN supplementation on liver function, liver fat content and lipid metabolism in healthy young subjects with acute binge drink. The main questions it aims to answer are: 1. 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, Nutritional Supplementation
What is being tested?: β-nicotinamide Mononucleotide and Maltodextrin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteChina
Study dates: 1 May 2024to 6 Apr 2025
Phase: Phase 1/2
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

Inclusion Criteria:
Sign informed consent
Exclusion Criteria:
Neurological disorders
Alcohol allergy
Alcohol addiction
Gastrointestinal diseases
Liver, kidney, cardiovascular or systemic diseases
Antibiotics were administered within 2 weeks prior to the trial
Participants who ate a vegetarian diet
Unable to use a smartphone or computer with Internet access
Participate in another intervention study

Trial locations and contacts

1 site in 1 country.

China1 site

Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310053

Other trials in China

About this study

Official title: Effect of β-nicotinamide Mononucleotide Intervention on Healthy Young Subjects With Acute Binge Drink: a Double-blinded, Randomized, Crossover Trial

if NMN administration could accelerate alcohol metabolism and alleviate hangover symptom;
if NMN administration could alleviate alcohol-induced liver injury and hepatic steatosis.

Read the detailed description

if NMN administration could accelerate alcohol metabolism and alleviate hangover symptom;
if NMN administration could alleviate alcohol-induced liver injury and hepatic steatosis.

Participants will be randomized into two groups (n=20), and take 4 NMN capsules (250mg/capsule) or 4 placebo capsules (maltodextrin), respectively. 15 minutes later, they are successively provided with same breakfast and then vodka with a dose of 1g/kg body weight. Venous blood are collected at 0h, 1h, 2h, 3h, 4h, 8h, 12h and 24h from each subject, respectively. In addition, nuclear magnetic resonance imaging (MRI) are taken at 0h, 4h and 24h after alcohol intake. After a 7-day washout period, volunteers are crossed over to another alternative group to receive the corresponding capsules and the test protocol repeats twice.

Conditions: Binge Drinking, Liver Injury, Nutritional Supplementation, Hepatic Steatosis
Being tested: β-nicotinamide Mononucleotide, Maltodextrin
Keywords: β-nicotinamide mononucleotide, Acute alcohol intake, Nutritional supplementation, 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.

β-nicotinamide MononucleotideDietary supplement
Also called NMN
After an 8-hour overnight fast, the participants ingested β-nicotinamide Mononucleotide capsules with a single morning dose of 1000mg. The purity of β-nicotinamide Mononucleotide capsules was no less than 97% according to high-performance liquid chromatography analysis.
MaltodextrinDietary supplement
After an 8-hour overnight fast, the participants ingested maltodextrin capsules with a single morning dose of 1000mg.

Study groups in NCT05882214
Study group	Role	What they receive
maltodextrin group	Placebo comparator	4 capsule with 1000mg ''maltodextrin'' Receives: Dietary Supplement: Maltodextrin
β-nicotinamide mononucleotide group	Experimental	4 capsule with 1000mg ''β-nicotinamide mononucleotide'' Receives: Dietary Supplement: β-nicotinamide Mononucleotide

What is being measured

The primary outcome is the main question the study is designed to answer.

Ethanol concentration
Ethanol concentration change in mg/dL of each set
Measured: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
Acetaldehyde concentration
Acetaldehyde concentration change in mg/dL of each set
Measured: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
Hepatic fibrosis change
Research blood hepatic fibrosis include:Hyaluronicacid in ng/mL;Laminin in ng/mL;type Ⅲ in ng/mL;precollagen in ng/mL;type Ⅳ collagen in ng/mL;Fibronect in ng/mL
Measured: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
hepatic function change
Research blood hepatic function include:TBIL in μmol/L;Direct bilirubin in μmol/L;Indirect bilirubin in μmol/L;Total bile acid in μmol/L
Measured: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
hepatic injury change
Research blood hepatic injury 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/L
Measured: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 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 day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
hangover cognition assessment tools after drinking
The survey tool consisted of many questions addressing cognition headache, nausea,vomiting,fatigue,concentration,thirst or dehydration,light sensitivity,sleeping difficulty,excessive sweating,anxiety,feelings of depression,trembling or shaking,dizziness,stomachache,and memory loss after drinking
Measured: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours

Secondary outcomes (4)

Laboratory markers of inflammation
Research blood Inflammatory factor include:Interleukin-2 in pg/ml;Interleukin-4 in pg/ml;Interleukin-6 in pg/ml;Interleukin-8 in pg/ml;Interleukin-10 in pg/ml;Tumor necrosis factor in pg/ml;Interferon gamma in pg/ml;Human IL-1 beta protein in pg/ml;High Sensitivity C-reactive Protein in mg/L
Measured: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
nicotinamide adenine dinucleotide metabolism change
NAD+ metabolism will be analysed by performing Liquid Chromatography Mass Spectrometer（LC-MS） on serum
Measured: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
Fecal metabolites
Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.
Measured: day1-2 and day 8-9 of each set
Metabolomics profiling
Targeted metabonomics are analyzed based on urine and faeces at all visits
Measured: day1-2 and day 8-9 of each set

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20246 Apr 2025

First posted31 May 2023
Study start1 May 2024
Primary completion18 Feb 2025
Study completion6 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)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 1/2
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Model description: Intervention method using β-nicotinamide mononucleotide
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05882214
Sponsor's protocol ID: Alleviate a hangover with NMN
Acronym: NMN-MeABD
Status last verified: Apr 2025
First submitted: 16 Mar 2023
Last updated: 10 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Protect volunteers' personal health data and personal privacy

Publications

Mammen RR, Natinga Mulakal J, Mohanan R, Maliakel B, Illathu Madhavamenon K. Clove Bud Polyphenols Alleviate Alterations in Inflammation and Oxidative Stress Markers Associated with Binge Drinking: A Randomized Double-Blinded Placebo-Controlled Crossover Study. J Med Food. 2018 Nov;21(11):1188-1196. doi: 10.1089/jmf.2017.4177. Epub 2018 Sep 20.
PubMed 30234415
Weissenborn R, Duka T. Acute alcohol effects on cognitive function in social drinkers: their relationship to drinking habits. Psychopharmacology (Berl). 2003 Jan;165(3):306-12. doi: 10.1007/s00213-002-1281-1. Epub 2002 Nov 19.
PubMed 12439627
Kim 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
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 24458173
Torp N, Israelsen M, Nielsen MJ, Astrand CP, Juhl P, Johansen S, Hansen CD, Madsen B, Villesen IF, Leeming DJ, Thiele M, Hansen T, Karsdal M, Krag A. Binge drinking induces an acute burst of markers of hepatic fibrogenesis (PRO-C3). Liver Int. 2022 Jan;42(1):92-101. doi: 10.1111/liv.15120. Epub 2021 Dec 10.
PubMed 34845832

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of β-nicotinamide Mononucleotide Intervention on Healthy Young Subjects With Acute Binge Drink: a Double-blinded, Randomized, Crossover Trial
ClinicalTrials.gov ID: NCT05882214
Acronym / sponsor ID: NMN-MeABD / Alleviate a hangover with NMN
Conditions: Binge Drinking, Liver Injury, Nutritional Supplementation, Hepatic Steatosis
Keywords: β-nicotinamide mononucleotide, Acute alcohol intake, Nutritional supplementation, Liver
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Zhejiang Chinese Medical UniversityOther government
Study start: 1 May 2024 (actual)
Primary completion: 18 Feb 2025 (actual)
Study completion: 6 Apr 2025 (actual)
First posted: 31 May 2023 (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.

if NMN administration could accelerate alcohol metabolism and alleviate hangover symptom;
if NMN administration could alleviate alcohol-induced liver injury and hepatic steatosis.

Detailed description

if NMN administration could accelerate alcohol metabolism and alleviate hangover symptom;
if NMN administration could alleviate alcohol-induced liver injury and hepatic steatosis.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Intervention method using β-nicotinamide mononucleotide

Arm	Type	Receives
maltodextrin group	Placebo comparator	Dietary Supplement: Maltodextrin4 capsule with 1000mg ''maltodextrin''
β-nicotinamide mononucleotide group	Experimental	Dietary Supplement: β-nicotinamide Mononucleotide4 capsule with 1000mg ''β-nicotinamide mononucleotide''

Who may qualify

Ages: 18 to 30 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

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
β-nicotinamide MononucleotideAlso: NMNAfter an 8-hour overnight fast, the participants ingested β-nicotinamide Mononucleotide capsules with a single morning dose of 1000mg. The purity of β-nicotinamide Mononucleotide capsules was no less than 97% according to high-performance liquid chromatography analysis.	Dietary supplement	β-nicotinamide mononucleotide group
MaltodextrinAfter an 8-hour overnight fast, the participants ingested maltodextrin capsules with a single morning dose of 1000mg.	Dietary supplement	maltodextrin group

Primary outcome

Ethanol concentration
Time frame: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
Ethanol concentration change in mg/dL of each set
Acetaldehyde concentration
Time frame: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
Acetaldehyde concentration change in mg/dL of each set
Hepatic fibrosis change
Time frame: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
Research blood hepatic fibrosis include:Hyaluronicacid in ng/mL;Laminin in ng/mL;type Ⅲ in ng/mL;precollagen in ng/mL;type Ⅳ collagen in ng/mL;Fibronect in ng/mL
hepatic function change
Time frame: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
Research blood hepatic function include:TBIL in μmol/L;Direct bilirubin in μmol/L;Indirect bilirubin in μmol/L;Total bile acid in μmol/L
hepatic injury change
Time frame: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
Research blood hepatic injury 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/L
Lipid metabolism change
Time frame: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 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
hangover cognition assessment tools after drinking
Time frame: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
The survey tool consisted of many questions addressing cognition headache, nausea,vomiting,fatigue,concentration,thirst or dehydration,light sensitivity,sleeping difficulty,excessive sweating,anxiety,feelings of depression,trembling or shaking,dizziness,stomachache,and memory loss after drinking

4 secondary outcomes

Laboratory markers of inflammation
Time frame: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
nicotinamide adenine dinucleotide metabolism change
Time frame: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours
Fecal metabolites
Time frame: day1-2 and day 8-9 of each set
Metabolomics profiling
Time frame: day1-2 and day 8-9 of each set

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 10 Apr 2025.
Background: PubMed 30234415Mammen RR, Natinga Mulakal J, Mohanan R, Maliakel B, Illathu Madhavamenon K. Clove Bud Polyphenols Alleviate Alterations in Inflammation and Oxidative Stress Markers Associated with Binge Drinking: A Randomized Double-Blinded Placebo-Controlled Crossover Study. J Med Food. 2018 Nov;21(11):1188-1196. doi: 10.1089/jmf.2017.4177. Epub 2018 Sep 20.
Background: PubMed 12439627Weissenborn R, Duka T. Acute alcohol effects on cognitive function in social drinkers: their relationship to drinking habits. Psychopharmacology (Berl). 2003 Jan;165(3):306-12. doi: 10.1007/s00213-002-1281-1. Epub 2002 Nov 19.
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.
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 34845832Torp N, Israelsen M, Nielsen MJ, Astrand CP, Juhl P, Johansen S, Hansen CD, Madsen B, Villesen IF, Leeming DJ, Thiele M, Hansen T, Karsdal M, Krag A. Binge drinking induces an acute burst of markers of hepatic fibrogenesis (PRO-C3). Liver Int. 2022 Jan;42(1):92-101. doi: 10.1111/liv.15120. Epub 2021 Dec 10.
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.

Jiaomei Li principal investigator

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 1/2 study testing β-nicotinamide Mononucleotide and Maltodextrin 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?

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 10 Apr 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Ethanol concentration (time frame: day1-2 and day 8-9 of each 30minutes and 1hour and 2 hours and 3 hours and 4 hours and 5 hours and 6 hours and 12 hours and 24 hours). The study lists 7 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 NCT05882214, which also lists 5 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 10 Apr 2025.