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

NCT05882214 | Completed Phase 1 DMC

• 1 other identifier: Alleviate a hangover with NMN
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 1.if NMN administration could accelerate alcohol metabolism and alleviate hangover symptom;
2. 2.if NMN administration could alleviate alcohol-induced liver injury and hepatic steatosis.

Conditions

Binge Drinking; Liver Injury; Nutritional Supplementation; Hepatic Steatosis

Keywords

β-nicotinamide mononucleotide; Acute alcohol intake; Nutritional supplementation; Liver

Outcome Measures

Primary Outcomes (7)

• Ethanol concentration

  Ethanol concentration change in mg/dL of each set

  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

  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

  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

  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

  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

  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

  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

  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

  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

  day1-2 and day 8-9 of each set

• Metabolomics profiling

  day1-2 and day 8-9 of each set

Study Arms (2)

maltodextrin group

PLACEBO COMPARATOR

4 capsule with 1000mg ''maltodextrin''

Dietary Supplement: Maltodextrin

β-nicotinamide mononucleotide group

EXPERIMENTAL

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

Dietary Supplement: β-nicotinamide Mononucleotide

Interventions

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.

Also known as: NMN

β-nicotinamide mononucleotide group

Maltodextrin DIETARY_SUPPLEMENT

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

maltodextrin group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• a. Sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Chinese Medical University: lead

Study Sites (1)

Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

Location

Related Publications (5)

• 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.

  PMID: 30234415 BACKGROUND

• 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.

  PMID: 12439627 BACKGROUND

• 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.

  PMID: 28750942 BACKGROUND

• 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.

  PMID: 24458173 BACKGROUND

• 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.

  PMID: 34845832 BACKGROUND

MeSH Terms

Conditions

Binge Drinking; Fatty Liver

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol Drinking; Drinking Behavior; Behavior; Mental Disorders; Liver Diseases; Digestive System Diseases

Study Officials

• Jiaomei Li

  Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intervention method using β-nicotinamide mononucleotide

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: May 31, 2023
• Study Start: May 1, 2024
• Primary Completion: February 18, 2025
• Study Completion: April 6, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)