NCT06983730

The Kidney's Response to Exercise in Heat, and the Impact of Vitamin B3 on This Response

Development of a Clinical Experimental Heat Stress Protocol and Exploration of the Effect of Niacinamide on Physiologic, Metabolic, and Biochemical Responses to Heat Stress

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Heat Strain
• Healthy Volunteer Study
• Kidney Dysfunction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin B3	1000mg once a day orally for two days, once the day before the exercise session, and once the day of the exercise session.

Timeline

• Start date: 2026-01-26
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2025-05-21
• Last updated: 2026-02-05

Locations

2 sites across 1 country: United States