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

Plain-language guide to NCT05882214: phase 1, phase 2 randomized trial of NAD+, 22 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05882214
Phase
phase 1, phase 2
Status
completed
Start
2024-05-01
Completion (planned or actual)
2025-02-18
Participants
22 (actual)
Design
randomized, quadruple-blind, health_services_research
Conditions studied
Binge Drinking; Liver Injury; Nutritional Supplementation; Hepatic Steatosis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1, phase 2) is built around NAD+.

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.

It had two arms (groups): maltodextrin group (placebo comparator) and β-nicotinamide mononucleotide group (experimental).

The registry classes the interventions as dietary supplement.

More on the Plan

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.

Who Took Part

The registry lists 22 actual participants took part.

It was open to men only aged from 18 years up to 30 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: neurological disorders; alcohol allergy; alcohol addiction.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.

In the crossover set-up each of the participants took both NAD+ and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received NAD+.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-05-01 with completion listed for 2025-02-18.

It ran at 1 site in China.

Its stated primary purpose is health services research.

What Was Measured

Primary outcome: Ethanol concentration. Acetaldehyde concentration. Hepatic fibrosis change.

It also tracked 4 secondary outcomes, for example Laboratory markers of inflammation, nicotinamide adenine dinucleotide metabolism change, Fecal metabolites and Metabolomics profiling.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of NAD+ in 22 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.

Our Notes on the Compound

NAD+: The coenzyme that accepts electrons at complex I.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.