ClinicalTrials.gg
CompletedNCT05882214NMN-MeABDUpdated Apr 10, 2025

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

A Phase 1/2 interventional study of β-nicotinamide Mononucleotide and Maltodextrin in Binge Drinking, Liver Injury and Nutritional Supplementation, sponsored by Zhejiang Chinese Medical University. Completed at 1 site in China. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by Zhejiang Chinese Medical University · Phase 1/2, Interventional, and Health services research

Phase
Phase 1/2
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study 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. if NMN administration could accelerate alcohol metabolism and alleviate hangover symptom;
  2. if NMN administration could alleviate alcohol-induced liver injury and hepatic steatosis.
Read the detailed description

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. if NMN administration could accelerate alcohol metabolism and alleviate hangover symptom;
  2. 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.

02

Conditions studied

  • Binge Drinking
  • Liver Injury
  • Nutritional Supplementation
  • Hepatic Steatosis

Keywords

  • β-nicotinamide mononucleotide
  • Acute alcohol intake
  • Nutritional supplementation
  • Liver
03

In context

Binge Drinking

71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.

This study's enrollment of 22 is below the median of 120 across 64 interventional studies indexed under Binge Drinking.

Browse Binge Drinking studies →

Lead sponsor

Zhejiang Chinese Medical University is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

a. Sign

Exclusion criteria

  1. Neurological disorders

    1. Alcohol allergy
    2. Alcohol addiction
    3. Gastrointestinal diseases
    4. Liver, kidney, cardiovascular or systemic diseases
    5. Antibiotics were administered within 2 weeks prior to the trial
    6. Participants who ate a vegetarian diet
    7. Unable to use a smartphone or computer with Internet access
    8. Participate in another intervention study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
22 participants (actual)

Study arms

  • Placebo comparator
    maltodextrin group

    4 capsule with 1000mg ''maltodextrin''

    Dietary Supplement: Maltodextrin

  • Experimental
    β-nicotinamide mononucleotide group

    4 capsule with 1000mg ''β-nicotinamide mononucleotide''

    Dietary Supplement: β-nicotinamide Mononucleotide

Interventions

  • 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.

    Also known as: NMN

  • Dietary supplementMaltodextrin

    After an 8-hour overnight fast, the participants ingested maltodextrin capsules with a single morning dose of 1000mg.

06

What researchers measure

Primary outcomes

  1. Ethanol concentration

    Ethanol concentration change in mg/dL of each set

    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

  2. Acetaldehyde concentration

    Acetaldehyde concentration change in mg/dL of each set

    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

  3. 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

    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

  4. 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

    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

  5. 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

    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

  6. 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

    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

  7. 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

    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

Secondary outcomes

  1. 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

    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

  2. nicotinamide adenine dinucleotide metabolism change

    NAD+ metabolism will be analysed by performing Liquid Chromatography Mass Spectrometer(LC-MS) on serum

    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

  3. Fecal metabolites

    Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.

    Time frame: day1-2 and day 8-9 of each set

  4. Metabolomics profiling

    Targeted metabonomics are analyzed based on urine and faeces at all visits

    Time frame: day1-2 and day 8-9 of each set

07

Study locations

1 site
  • Zhejiang Chinese Medical University
    Hangzhou, Zhejiang 310053, China
08

References and documents

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 ↗

Individual participant data

Plan to share: No — Protect volunteers' personal health data and personal privacy

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2024 to primary completion in Feb 2025, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2023
First posted
May 31, 2023
StartActual
May 1, 2024
Primary completionActual
Feb 18, 2025
CompletionActual
Apr 6, 2025
Last update
Apr 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05882214
Lead sponsor
Zhejiang Chinese Medical University
Responsible party
Li Lab,MD (Professor, Zhejiang Chinese Medical University) — Principal investigator
First posted
May 31, 2023
Start date
May 1, 2024
Primary completion
Feb 18, 2025
Completion
Apr 6, 2025
Last update
Apr 10, 2025

Study contacts

Jiaomei Li
principal investigator · Zhejiang Chinese Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Nicotinamide Mononucleotide

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