Binge Drinking, Hepatic Steatosis, Liver Injury, Nutritional Supplementation
Conditions
Keywords
β-nicotinamide mononucleotide, Acute alcohol intake, Nutritional supplementation, Liver
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.
Interventions
DIETARY_SUPPLEMENTβ-nicotinamide Mononucleotide
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.
DIETARY_SUPPLEMENTMaltodextrin
After an 8-hour overnight fast, the participants ingested maltodextrin capsules with a single morning dose of 1000mg.
Sponsors
Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Intervention method using β-nicotinamide mononucleotide
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
China
Outcome results
None listed