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

Short name NMN-MeABD

NCTNCT05882214Other idAlleviate a hangover with NMN

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1/2
Enrollment: 22 participants (actual)
Sponsor: Zhejiang Chinese Medical University · Other gov
Design: Randomized · Quadruple masking
Countries: 1 country
China
Start: 1 May 2024
Primary completion: 18 Feb 2025
Completion: 6 Apr 2025
First posted: 31 May 2023
Last update posted: 10 Apr 2025
Conditions: Binge Drinking · Liver Injury · Nutritional Supplementation · Hepatic Steatosis

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026

Ph 1/2
NMN-MeABD
NCT05882214
1 May 2024 to 6 Apr 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

β-nicotinamide MononucleotideDietary supplement
MaltodextrinDietary supplement

Arms2

Placebo comparator
maltodextrin group
4 capsule with 1000mg ''maltodextrin''
Experimental
β-nicotinamide mononucleotide group
4 capsule with 1000mg ''β-nicotinamide mononucleotide''

Primary outcomes7

Outcomes the sponsor listed as primary.

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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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(4)

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
Registry description
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
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
Registry description
NAD+ metabolism will be analysed by performing Liquid Chromatography Mass Spectrometer（LC-MS） on serum
Fecal metabolites
Time frame · day1-2 and day 8-9 of each set
Registry description
Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.
Metabolomics profiling
Time frame · day1-2 and day 8-9 of each set
Registry description
Targeted metabonomics are analyzed based on urine and faeces at all visits

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 30 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

1. Inclusion Criteria: a. Sign informed consent 2. Exclusion Criteria: 1. Neurological disorders 2. Alcohol allergy 3. Alcohol addiction 4. Gastrointestinal diseases 5. Liver, kidney, cardiovascular or systemic diseases 6. Antibiotics were administered within 2 weeks prior to the trial 7. Participants who ate a vegetarian diet 8. Unable to use a smartphone or computer with Internet access 9. Participate in another intervention study

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