Healthy Volunteer Study, Heat Strain, Kidney Dysfunction
Conditions
Keywords
NAD+, Niacinamide, Vitamin B3, Experimental heat strain
Brief summary
The goal of this clinical trial is to learn about the processes occurring in the kidneys while under heat stress in healthy volunteers. The main questions it aims to answer are: * How do the chemicals produced by the body change under conditions of higher versus lower heat stress? * What role does a specific area of the body's metabolism, known as NAD+ metabolism, play in the body's response to heat stress, and can this response be modified by taking vitamin B3?
Detailed description
To answer these questions, researchers will compare the chemical changes in each participant under progressively higher levels of heat stress, and while taking either vitamin B3 or a placebo. This clinical trial will occur in two stages. Participants may choose participate in stage 1 only, stage 2 only, or both parts of this clinical trial. During stage 1, participants will exercise using a stationary rowing ergometer in a hot and humid environmental chamber for three sessions, each session separated by about a week. * Each session, they will be asked to work out at a progressively higher intensity with climate conditions kept the same in the chamber. * More intense exercise produces greater heat stress, resulting in lower, moderate, and higher levels of heat stress exposure across the three sessions. * Researchers will see how chemicals in the blood and urine, along with physical measurements like heart rate and body temperature, change across these different levels of heat stress. During stage 2, participants will exercise using the same rowing ergometer in the same environmental chamber. They will do this for two sessions, each separated by about a week. * One of the sessions each participant will take vitamin B3, and the other session each participant will take placebo. * Heat stress exposure will be the same each session. * Researchers will again see how chemicals in the blood and urine, along with physical measurements like heart rate and body temperature, differ between sessions with vitamin B3 and sessions with placebo
Interventions
DIETARY_SUPPLEMENTVitamin B3
1000mg once a day orally for two days, once the day before the exercise session, and once the day of the exercise session.
Sponsors
Beth Israel Deaconess Medical Center
Boston University Charles River Campus
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
There are two phases to this study. The first phase is a dose-response phase evaluating the effect of experimental heat strain on kidney metabolic and stress response. The second phase uses this experimental heat strain at a dose producing kidney metabolic and stress response to conduct a crossover trial investigating how Vitamin B3 impacts the kidney's metabolic and stress response during heat strain.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteer * Any race * Estimated glomerular filtration rate greater than 90 ml/min/1.73m2 * Urine albumin/creatinine ratio less than 30mg/g * Nonsmoker * No regular dietary supplements, particularly vitamin B3 * Physically fit, defined as having a VO2 max of between 35 and 60mL/kg/min
Exclusion criteria
* Medical condition preventing safe participation in exercise during heat * Allergy to Vitamin B3 * Severe food allergies or dietary restrictions that would preclude eating the planned study diet without major modifications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary neutrophil gelatinase-associated lipocalin | Pre- and immediately post- heat stress exposure | Marker of stress and injury in the kidney |
| Urinary TIMP2 (tissue inhibitor of metalloproteinase-2) and IGFBP7 (insulin-like growth factor-binding protein 7) | Pre- and immediately post- heat stress exposure | Marker of kidney stress and injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine | Pre- and immediately post- heat stress exposure | Marker of kidney function |
| Urine Quinolinate to Tryptophan Ratio | Pre- and immediately post- heat stress exposure | Ratio of quinolinate to tryptophan in the urine |
Countries
United States
Contacts
CONTACTNathan H Raines, MD MPH
PRINCIPAL_INVESTIGATORNathan H Raines, MD MPH
Beth Israel Deaconess Medical Center
Outcome results
None listed