Clinical trial NCT06983730: The Kidney's Response to Exercise in Heat, and the Impact of Vitamin B3 on This Response
Official title: Development of a Clinical Experimental Heat Stress Protocol and Exploration of the Effect of Niacinamide on Physiologic, Metabolic, and Biochemical Responses to Heat Stress
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Heat Strain
Healthy Volunteer Study
Kidney Dysfunction
Keywords: NAD+
Niacinamide
Vitamin B3
Experimental heat strain
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Boston University Charles River Campus
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-05-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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 an upper body workout device 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 upper body workout device 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, change between sessions with vitamin B3 and sessions with placebo

Eligibility criteria: 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 active, defined as doing at least 150 minutes of physical activity in an average week

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

Primary outcomes:
measure: Urinary neutrophil gelatinase-associated lipocalin
timeFrame: Pre- and 1 hour post- heat stress exposure
Secondary outcomes:
measure: Urine Quinolinate to Tryptophan Ratio
timeFrame: Pre- and 1 hour post- heat stress exposure
measure: Serum creatinine
timeFrame: Pre- and 1 hour post- heat stress exposure
Other outcomes:
measure: Urine and serum metabolites, including metabolites related to nicotinamide adenine dinucleotide (NAD+)
timeFrame: Pre-, during, and 1 hour and 24 hours post- heat stress exposure
measure: Urine and serum nicotinamide levels
timeFrame: Pre-, during, and 1 hour and 24 hours post- heat stress exposure
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Nathan H Raines, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: