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

Primary Purpose

Binge Drinking, Liver Injury, Nutritional Supplementation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
β-nicotinamide Mononucleotide
Maltodextrin
Sponsored by
Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Binge Drinking focused on measuring β-nicotinamide mononucleotide, Acute alcohol intake, Nutritional supplementation, Liver

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Zhejiang Chinese Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

maltodextrin group

β-nicotinamide mononucleotide group

Arm Description

4 capsule with 1000mg ''maltodextrin''

4 capsule with 1000mg ''β-nicotinamide mononucleotide''

Outcomes

Primary Outcome Measures

Ethanol concentration
Ethanol concentration change in mg/dL of each set
Acetaldehyde concentration
Acetaldehyde concentration change in mg/dL of each set
Hepatic fibrosis change
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
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
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
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
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

Laboratory markers of inflammation
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
NAD+ metabolism will be analysed by performing Liquid Chromatography Mass Spectrometer(LC-MS) on serum
Fecal metabolites
Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.
Metabolomics profiling
Targeted metabonomics are analyzed based on urine and faeces at all visits

Full Information

First Posted
March 16, 2023
Last Updated
September 20, 2023
Sponsor
Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05882214
Brief Title
Metabolic Changes Induced by NMN in Healthy Subjects With Acute Binge Drink
Acronym
NMN-MeABD
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
July 19, 2024 (Anticipated)
Study Completion Date
July 18, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Drinking, Liver Injury, Nutritional Supplementation, Hepatic Steatosis
Keywords
β-nicotinamide mononucleotide, Acute alcohol intake, Nutritional supplementation, Liver

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
maltodextrin group
Arm Type
Placebo Comparator
Arm Description
4 capsule with 1000mg ''maltodextrin''
Arm Title
β-nicotinamide mononucleotide group
Arm Type
Experimental
Arm Description
4 capsule with 1000mg ''β-nicotinamide mononucleotide''
Intervention Type
Dietary Supplement
Intervention Name(s)
β-nicotinamide Mononucleotide
Other Intervention Name(s)
NMN
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
After an 8-hour overnight fast, the participants ingested maltodextrin capsules with a single morning dose of 1000mg.
Primary Outcome Measure Information:
Title
Ethanol concentration
Description
Ethanol concentration change in mg/dL of each set
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
Title
Acetaldehyde concentration
Description
Acetaldehyde concentration change in mg/dL of each set
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
Title
Hepatic fibrosis change
Description
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
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
Title
hepatic function change
Description
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
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
Title
hepatic injury change
Description
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
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
Title
Lipid metabolism change
Description
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
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
Title
hangover cognition assessment tools after drinking
Description
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
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
Secondary Outcome Measure Information:
Title
Laboratory markers of inflammation
Description
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
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
Title
nicotinamide adenine dinucleotide metabolism change
Description
NAD+ metabolism will be analysed by performing Liquid Chromatography Mass Spectrometer(LC-MS) on serum
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
Title
Fecal metabolites
Description
Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.
Time Frame
day1-2 and day 8-9 of each set
Title
Metabolomics profiling
Description
Targeted metabonomics are analyzed based on urine and faeces at all visits
Time Frame
day1-2 and day 8-9 of each set

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaixin Pan
Phone
08615705811859
Email
zcmunutrition@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiaomei Li
Organizational Affiliation
Zhejiang Chinese Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Chinese Medical University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaixin Pan
Phone
08615705811859
Email
zcmunutrition@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Protect volunteers' personal health data and personal privacy
Citations:
PubMed Identifier
30234415
Citation
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Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
28750942
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.
Results Reference
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PubMed Identifier
24458173
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Metabolic Changes Induced by NMN in Healthy Subjects With Acute Binge Drink

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