Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity

Drug Toxicity Clinical Trial

Official title:

Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214468
• Other study ID #: 23-067/2026659-2
• Status: Recruiting
• Phase: Phase 1
• Start date: January 15, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: January 2024
• Source: University of South Alabama
• Contact: marie E migaud, PHD
• Phone: 2514104938
• Email: mmigaud[@]southalabama.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• n/a

Exclusion Criteria:

• Individual allergic to acetaminophen or nicotinamide riboside

Related Conditions & MeSH terms

• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions

Intervention

Combination Product:
• Acetaminophen and Nicotinamide Riboside
Collection of urine at different time intervals following ingestion of Tylenol plus Nicotinamide Riboside

Drug:
• Acetaminophen
Collection of urine at different time intervals following ingestion of Tylenol only

Locations

Country	Name	City	State
United States	University of South Alabama	Mobile	Alabama

Sponsors (5)

Lead Sponsor	Collaborator
University of South Alabama	National Aeronautics and Space Administration (NASA), Rutgers University, University of Alabama at Birmingham, University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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