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

Hepatic Steatosis Clinical Trial

— NMN-MeABD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05882214
• Other study ID #: Alleviate a hangover with NMN
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: July 18, 2026

Study information

• Verified date: February 2024
• Source: Zhejiang Chinese Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 18, 2026
• Est. primary completion date: July 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• ß-nicotinamide Mononucleotide
After an 8-hour overnight fast, the participants ingested ß-nicotinamide Mononucleotide capsules with a single morning dose of 1000mg. The purity of ß-nicotinamide Mononucleotide capsules was no less than 97% according to high-performance liquid chromatography analysis.
• Maltodextrin
After an 8-hour overnight fast, the participants ingested maltodextrin capsules with a single morning dose of 1000mg.

Locations

Country	Name	City	State
China	Zhejiang Chinese Medical University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Hepatic fibrosis change	Research blood hepatic fibrosis include:Hyaluronicacid in ng/mL;Laminin in ng/mL;type ? in ng/mL;precollagen in ng/mL;type ? 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
Primary	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
Primary	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
Primary	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
Primary	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	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	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	nicotinamide adenine dinucleotide metabolism change	NAD+ metabolism will be analysed by performing Liquid Chromatography Mass Spectrometer(LC-MS) on serum	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	Fecal metabolites	Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.	day1-2 and day 8-9 of each set
Secondary	Metabolomics profiling	Targeted metabonomics are analyzed based on urine and faeces at all visits	day1-2 and day 8-9 of each set