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

• Sponsor: Zhejiang Chinese Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05882214
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 37.4
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Binge Drinking; Liver Injury; Nutritional Supplementation; Hepatic Steatosis	Dietary Supplement: β-nicotinamide Mononucleotide; Dietary Supplement: Maltodextrin	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Effect of β-nicotinamide Mononucleotide Intervention on Healthy Young Subjects With Acute Binge Drink: a Double-blinded, Randomized, Crossover Trial
• Anticipated Study Start Date: Jun 5, 2023
• Anticipated Primary Completion Date: Jul 19, 2024
• Anticipated Study Completion Date: Jul 18, 2026

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: maltodextrin group 4 capsule with 1000mg ''maltodextrin''	Dietary Supplement: Maltodextrin; After an 8-hour overnight fast, the participants ingested maltodextrin capsules with a single morning dose of 1000mg.
Experimental: β-nicotinamide mononucleotide group 4 capsule with 1000mg ''β-nicotinamide mononucleotide''	Dietary Supplement: β-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.; Other Names: NMN

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

1. 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

2. 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

3. 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.

4. Metabolomics profiling [day1-2 and day 8-9 of each set]

   Targeted metabonomics are analyzed based on urine and faeces at all visits

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

1. Inclusion Criteria:

1. Sign informed consent

1. Exclusion Criteria:

2. Neurological disorders

3. Alcohol allergy

4. Alcohol addiction

5. Gastrointestinal diseases

6. Liver, kidney, cardiovascular or systemic diseases

7. Antibiotics were administered within 2 weeks prior to the trial

8. Participants who ate a vegetarian diet

9. Unable to use a smartphone or computer with Internet access

10. Participate in another intervention study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Chinese Medical University	Hangzhou	Zhejiang	China	310053

Sponsors and Collaborators

• Zhejiang Chinese Medical University

Investigators

• Principal Investigator: Jiaomei Li, Zhejiang Chinese Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Li lab,MD, Professor, Zhejiang Chinese Medical University
• ClinicalTrials.gov Identifier: NCT05882214
• Other Study ID Numbers: Alleviate a hangover with NMN
• First Posted: May 31, 2023
• Last Update Posted: May 31, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Li lab,MD, Professor, Zhejiang Chinese Medical University: β-nicotinamide mononucleotide; Acute alcohol intake; Nutritional supplementation; Liver
• Additional relevant MeSH terms: Fatty Liver; Binge Drinking; Niacinamide; Niacin; Nicotinic Acids

Study Results

No Results Posted as of May 31, 2023