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NCT Number: NCT06214468

Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity

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.

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Key information

Conditions

Drug Toxicity Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of South Alabama

Mobile, Alabama, 36604, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • n/a

Exclusion criteria

  • Individual allergic to acetaminophen or nicotinamide riboside

Treatment and study plan

Acetaminophen and Nicotinamide Riboside

Combination Product

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

Other names: Tylenol and Vitamin B3

Acetaminophen

Drug

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

Other names: Tylenol

Primary outcomes

  1. Count the quantity of NAD(P)(H) present with exposure to acetaminophen, with and without NR

    Time frame: At consent and 6 hours post dose

    Multiple blood draws pre and post dose of acetaminophen plus NR

  2. Count the DNA damage occurring upon space-like stressors following exposure to acetaminophen, with and without NR

    Time frame: At consent and 6 hours post dose

    Multiple blood draws pre and post dose of acetaminophen with or without NR.

  3. Count the quantity of ox-NAD(P) present with exposure to acetaminophen, with and without NR

    Time frame: At consent and 6 hours post dose

    Multiple blood draws pre and post dose of acetaminophen plus NR

  4. Count the quantity of PYR-ribosides present with exposure to acetaminophen, with and without NR

    Time frame: Pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and

    A urine sample will be collected from consented volunteers pre and post dose of acetaminophen plus NR

  5. Count the quantity of PYR-nucleotides present with exposure to acetaminophen, with and without NR

    Time frame: Pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and

    A blood sample will be collected from consented volunteers pre and post dose of acetaminophen plus NR

Sponsors and collaborators

Lead sponsor

University of South Alabama

Other

Collaborators

  • National Aeronautics and Space Administration (NASA)
  • Rutgers University
  • University of Alabama at Birmingham
  • University of Nevada, Las Vegas

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 19, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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