Effect of β-nicotinamide Mononucleotide Intervention on Healthy Young Subjects With Acute Binge Drink: a Double-blinded, Randomized, Crossover Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Ethanol concentration
Study Overview
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:
- if NMN administration could accelerate alcohol metabolism and alleviate hangover symptom;
- 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:
- if NMN administration could accelerate alcohol metabolism and alleviate hangover symptom;
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion Criteria:
- •a. Sign informed consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Ethanol concentration
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
Investigators
Li Lab,MD
Professor
Zhejiang Chinese Medical University