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

Beth Israel Lahey Health

Status and phase: Enrolling; Early Phase 1

Conditions: Heat Strain; Kidney Dysfunction; Healthy Volunteer Study

Treatments: Dietary Supplement: Vitamin B3

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06983730

K23DK138320 (U.S. NIH Grant/Contract)

2024P000637

Details and patient eligibility

About

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?

Full 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

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups

Vitamin B3, then placebo

Experimental group

Description:

Individuals will receive 1000mg oral Vitamin B3 daily for two days leading up to their first exercise session, and oral placebo daily for two days leading up to their second exercise session.

Treatment:

Dietary Supplement: Vitamin B3

Placebo, then vitamin B3

Experimental group

Description:

Individuals will receive 1000mg oral placebo daily for two days leading up to their first exercise session, and oral vitamin B3 daily for two days leading up to their second exercise session.

Treatment:

Dietary Supplement: Vitamin B3