Metabolic Changes Induced by NMN in Healthy Subjects With Acute Binge Drink
- Conditions
- Liver InjuryHepatic SteatosisBinge DrinkingNutritional Supplementation
- Interventions
- Dietary Supplement: MaltodextrinDietary Supplement: β-nicotinamide Mononucleotide
- Registration Number
- NCT05882214
- Lead Sponsor
- Zhejiang Chinese Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 22
a. Sign informed consent 2.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description maltodextrin group Maltodextrin 4 capsule with 1000mg ''maltodextrin'' β-nicotinamide mononucleotide group β-nicotinamide Mononucleotide 4 capsule with 1000mg ''β-nicotinamide mononucleotide''
- Primary Outcome Measures
Name Time Method Ethanol concentration 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
Acetaldehyde concentration 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
Hepatic fibrosis 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 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 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
hepatic injury 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 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 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
hangover cognition assessment tools 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 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 Outcome Measures
Name Time Method 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 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 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
Fecal metabolites day1-2 and day 8-9 of each set Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.
Metabolomics profiling day1-2 and day 8-9 of each set Targeted metabonomics are analyzed based on urine and faeces at all visits
Trial Locations
- Locations (1)
Zhejiang Chinese Medical University
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Chinese Medical University🇨🇳Hangzhou, Zhejiang, China