Clinical trial NCT05882214: Metabolic Changes Induced by NMN in Healthy Subjects With Acute Binge Drink
Official title: Effect of β-nicotinamide Mononucleotide Intervention on Healthy Young Subjects With Acute Binge Drink: a Double-blinded, Randomized, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Binge Drinking
Liver Injury
Nutritional Supplementation
Hepatic Steatosis
Keywords: β-nicotinamide mononucleotide
Acute alcohol intake
Nutritional supplementation
Liver
Lead sponsor: Zhejiang Chinese Medical University
Sponsor class: OTHER_GOV
First posted: 2023-05-31
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Intervention method using β-nicotinamide mononucleotide
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ethanol concentration
timeFrame: 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
measure: Acetaldehyde concentration
timeFrame: 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
measure: Hepatic fibrosis change
timeFrame: 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
measure: hepatic function change
timeFrame: 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
measure: hepatic injury change
timeFrame: 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
measure: Lipid metabolism change
timeFrame: 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
measure: hangover cognition assessment tools after drinking
timeFrame: 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:
measure: Laboratory markers of inflammation
timeFrame: 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
measure: nicotinamide adenine dinucleotide metabolism change
timeFrame: 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
measure: Fecal metabolites
timeFrame: day1-2 and day 8-9 of each set
measure: Metabolomics profiling
timeFrame: day1-2 and day 8-9 of each set
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: Zhejiang Chinese Medical University
name: Jiaomei Li
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.