Actively Recruiting
Development of a Heat Stress Protocol and Effects of Niacinamide on Kidney and Metabolic Responses
Led by Beth Israel Deaconess Medical Center · Updated on 2026-02-05
28
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
B
Boston University Charles River Campus
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how the kidneys respond to heat stress in healthy adults and how vitamin B3 might affect this response. The study aims to understand changes in body chemicals during different levels of heat stress and explore the role of NAD+ metabolism in this process. This early phase clinical trial also examines whether vitamin B3 can modify the body's reaction to heat stress. The trial has two stages. In stage 1, participants will exercise on a rowing machine in a hot and humid chamber over three sessions spaced about a week apart. Each session increases exercise intensity, producing progressively higher heat stress levels. In stage 2, participants will complete two exercise sessions under the same heat stress conditions; one session after taking vitamin B3 and the other after taking a placebo. Vitamin B3 or placebo is taken orally at 1000mg daily for two days before each session, with the order randomized. Participants will have blood and urine samples collected before and immediately after heat stress exposure to measure chemicals related to kidney function and metabolism, including urinary neutrophil gelatinase-associated lipocalin and tissue inhibitors. Physical measures like heart rate and body temperature will also be recorded. The study monitors how these factors change with heat stress and vitamin B3 intake. Total participation may include multiple visits over several weeks with careful monitoring throughout.
CONDITIONS
Brief Title
The Kidney's Response to Exercise in Heat, and the Impact of Vitamin B3 on This Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 3 weeks
Participants exercise using a rowing ergometer in a hot and humid chamber across progressively higher heat stress levels to assess chemical and physical changes.
3 exercise sessions, each about a week apart (in-person)
Duration - Approximately 2 weeks
Participants complete two exercise sessions in the heat chamber, one after taking vitamin B3 and one after taking placebo, to compare responses.
2 exercise sessions, each about a week apart (in-person)
Trial Site Locations
Total: 2 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Boston University
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
N
Nathan H Raines, MD MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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