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.

Study Overview

• Status: Recruiting
• Conditions: Drug Toxicity
• Intervention / Treatment: Combination product: Acetaminophen and Nicotinamide Riboside; Drug: Acetaminophen

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: marie E migaud, PHD; Phone Number: 2514104938; Email: mmigaud@southalabama.edu
• Study Contact Backup: Name: BENJAMIN CAMPBELL; Phone Number: 2513305253; Email: brcampbell@health.southalabams.edu

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • Recruiting
      • University Of South Alabama
      • Contact: Marie Migaud, PhD; Phone Number: 251-665-8000; Email: mmigaud@southalabama.edu
      • Contact: STEFANIE WHITE, CCRP; Phone Number: 2514459834; Email: swhite@southalabama.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• n/a

Exclusion Criteria:

• Individual allergic to acetaminophen or nicotinamide riboside

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Tylenol and Nicotinamide Riboside	Combination product: Acetaminophen and Nicotinamide Riboside; Collection of urine at different time intervals following ingestion of Tylenol plus Nicotinamide Riboside; Other Names: Tylenol and Vitamin B3; Drug: Acetaminophen; Collection of urine at different time intervals following ingestion of Tylenol only; Other Names: Tylenol
Active Comparator: Tylenol Only	Drug: Acetaminophen; Collection of urine at different time intervals following ingestion of Tylenol only; Other Names: Tylenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count the quantity of NAD(P)(H) present with exposure to acetaminophen, with and without NR	Multiple blood draws pre and post dose of acetaminophen plus NR	At consent and 6 hours post dose
Count the DNA damage occurring upon space-like stressors following exposure to acetaminophen, with and without NR	Multiple blood draws pre and post dose of acetaminophen with or without NR.	At consent and 6 hours post dose
Count the quantity of ox-NAD(P) present with exposure to acetaminophen, with and without NR	Multiple blood draws pre and post dose of acetaminophen plus NR	At consent and 6 hours post dose
Count the quantity of PYR-ribosides present with exposure to acetaminophen, with and without NR	A urine sample will be collected from consented volunteers pre and post dose of acetaminophen plus NR	Pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and
Count the quantity of PYR-nucleotides present with exposure to acetaminophen, with and without NR	A blood sample will be collected from consented volunteers pre and post dose of acetaminophen plus NR	Pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and

Collaborators and Investigators

• Sponsor: University of South Alabama
• Collaborators: University of Alabama at Birmingham; University of Nevada, Las Vegas; Rutgers University; National Aeronautics and Space Administration (NASA)
• Investigators: Principal Investigator: marie migaud, PHD, University Of South Alabama

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2024
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Acetaminophen; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: 23-067/2026659-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes