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Completed

NCT Number: NCT05882214

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

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.

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Key information

Conditions

Binge Drinking Alcohol Drinking Alcohol-Related Disorders Behavior Chemically-Induced Disorders Digestive System Diseases Drinking Behavior Fatty Liver Hepatic Steatosis Liver Diseases Liver Injury Mental Disorders Nutritional Supplementation Substance-Related Disorders

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

About this study

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:

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:

a. 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

Treatment and study plan

β-nicotinamide Mononucleotide

Dietary Supplement

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.

Other names: NMN

Maltodextrin

Dietary Supplement

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. 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

    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

  2. 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

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

  3. Fecal metabolites

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

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

  4. Metabolomics profiling

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

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

Sponsors and collaborators

Lead sponsor

Zhejiang Chinese Medical University

Other Gov

Registry information

Official study title

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

Acronym: NMN-MeABD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 31, 2023
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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