Drug Toxicity
Conditions
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.
Interventions
COMBINATION_PRODUCTAcetaminophen and Nicotinamide Riboside
Collection of urine at different time intervals following ingestion of Tylenol plus Nicotinamide Riboside
DRUGAcetaminophen
Collection of urine at different time intervals following ingestion of Tylenol only
Sponsors
University of South Alabama
National Aeronautics and Space Administration (NASA)
University of Nevada, Las Vegas
University of Alabama at Birmingham
Rutgers University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* n/a
Exclusion criteria
* Individual allergic to acetaminophen or nicotinamide riboside
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORmarie migaud, PHD
University of South Alabama
Outcome results
None listed