Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity

NCT ID: NCT06214468

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2025-04-30

Brief Summary

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Over-the-counter drugs like acetaminophen (e.g., Tylenol®) can be detrimental. In space, astronauts who have pain and constant discomfort use acetaminophen extensively. Investigators are studying the effects of acetaminophen under space-like conditions since acetaminophen might affect astronauts' health. Investigators also wish to see whether a dietary supplement can reduce some negative effects of acetaminophen.

It is believed that acetaminophen promotes the productions of chemicals in the body that could be toxic.

In this study, measurements of these chemicals in urine after ingestion of 1 tablet of acetaminophen and compare these measurements to when acetaminophen is taken at the same time as a dietary supplement. This study will also explore whether these products are more abundant when blood is placed under conditions that mimic space. Therefore, this study will collect blood from a few volunteers who took acetaminophen, and acetaminophen with the dietary supplement.

Detailed Description

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In space, astronauts are constantly exposed to conditions the body is not used to. To relieve pain and discomfort, astronauts often use acetaminophen. This study investigates a possible negative synergistic effect between using acetaminophen and space-like stressors as they both generate oxidative stress and produce toxins that distribute around the body and disrupt cellular function in other tissues. The study seeks to examine whether a dietary supplement, nicotinamide riboside (NR), can reduce some adverse effects of these toxins by reducing their production when taking acetaminophen.

The study will measure these materials in urine after ingestion of 1 gram of acetaminophen and compare these measurements to when the same amount of acetaminophen is taken at the same time as NR. It will also evaluate whether these toxins are more abundant when blood is placed under conditions resembling space. Therefore, blood collection from a few volunteers who take acetaminophen, and acetaminophen with NR. Ultimately, this work will establish whether NR could reduce the generation of specific endotoxins.

For this study, male and female volunteers are needed to donate urine for testing the effect of 1000mg dose of Tylenol® and one 1000mg dose of Tylenol® with one 250mg dose of Nicotinamide Riboside on the abundance of uremic toxins in urine and in blood. Volunteers are also needed to donate blood.

Conditions

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Drug Toxicity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

This study takes place over 2 days, and the study runs twice, two weeks apart. Upon enrolment and consent, the participant will provide a urine sample then be given acetaminophen and Nicotinamide Riboside (NR). Participant are asked to collect 4 urine samples over a 24 hour period and record the time of the collection each time. Two weeks after this first collection, participants are asked to repeat the process but this time with only acetaminophen ingestion.

Tubes will be provided for the collection of the urine and zip lock bags will be provided to place the tubes in after samples have been collected. All samples should be stored in the freezer until completion of the samples at which time they should be brought to the USA Mitchell Cancer Institute. Some volunteers will participate in 4 total blood draws collected on the first day at the time of the consent then again 6 hours after taking NR and Acetaminophen. Blood samples will be taken again during the second collection period.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators
Sample will be assigned a unique identifier to de-identify samples from the study team. This unique identifier will be assigned by the clinical manager, who will be providing the informed consent. Each sample will be labeled to include gender, race and ethnicity.

Study Groups

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Tylenol and Nicotinamide Riboside

Group Type OTHER

Acetaminophen and Nicotinamide Riboside

Intervention Type COMBINATION_PRODUCT

Collection of urine at different time intervals following ingestion of Tylenol plus Nicotinamide Riboside

Acetaminophen

Intervention Type DRUG

Collection of urine at different time intervals following ingestion of Tylenol only

Tylenol Only

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Collection of urine at different time intervals following ingestion of Tylenol only

Interventions

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Acetaminophen and Nicotinamide Riboside

Collection of urine at different time intervals following ingestion of Tylenol plus Nicotinamide Riboside

Intervention Type COMBINATION_PRODUCT

Acetaminophen

Collection of urine at different time intervals following ingestion of Tylenol only

Intervention Type DRUG

Other Intervention Names

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Tylenol and Vitamin B3 Tylenol

Eligibility Criteria

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Inclusion Criteria

* n/a

Exclusion Criteria

* Individual allergic to acetaminophen or nicotinamide riboside
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Aeronautics and Space Administration (NASA)

FED

Sponsor Role collaborator

University of Nevada, Las Vegas

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Rutgers University

OTHER

Sponsor Role collaborator

University of South Alabama

OTHER

Sponsor Role lead

Responsible Party

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Marie Migaud

Professor of Pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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marie migaud, PHD

Role: PRINCIPAL_INVESTIGATOR

University of South Alabama

Locations

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University of South Alabama

Mobile, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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marie E migaud, PHD

Role: CONTACT

2514104938

BENJAMIN CAMPBELL

Role: CONTACT

2513305253

Facility Contacts

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Marie Migaud, PhD

Role: primary

251-665-8000

STEFANIE WHITE, CCRP

Role: backup

2514459834

Other Identifiers

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23-067/2026659-2

Identifier Type: -

Identifier Source: org_study_id

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