Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity

Phase 1

Recruiting

• Conditions: Drug Toxicity
• Interventions: Combination Product: Acetaminophen and Nicotinamide Riboside; Drug: Acetaminophen

• Registration Number: NCT06214468
• Lead Sponsor: University of South Alabama

Brief 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.

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 Timeline

• Study First Submitted: 2023-12-07
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study Start: 2024-01-15
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19
• Primary Completion: 2024-06-15
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• n/a

Exclusion Criteria

• Individual allergic to acetaminophen or nicotinamide riboside

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tylenol and Nicotinamide Riboside	Acetaminophen and Nicotinamide Riboside	-
Tylenol and Nicotinamide Riboside	Acetaminophen	-
Tylenol Only	Acetaminophen	-

Primary Outcome Measures

Name	Time	Method
Count the quantity of NAD(P)(H) present with exposure to acetaminophen, with and without NR	At consent and 6 hours post dose	Multiple blood draws pre and post dose of acetaminophen plus NR
Count the DNA damage occurring upon space-like stressors following exposure to acetaminophen, with and without NR	At consent and 6 hours post dose	Multiple blood draws pre and post dose of acetaminophen with or without NR.
Count the quantity of ox-NAD(P) present with exposure to acetaminophen, with and without NR	At consent and 6 hours post dose	Multiple blood draws pre and post dose of acetaminophen plus NR
Count the quantity of PYR-ribosides present with exposure to acetaminophen, with and without NR	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
Count the quantity of PYR-nucleotides present with exposure to acetaminophen, with and without NR	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

Trial Locations

Locations (1)

University of South Alabama; 🇺🇸 Mobile, Alabama, United States