The Kidney's Response to Exercise in Heat, and the Impact of Vitamin B3 on This Response
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBeth Israel Deaconess Medical Center
About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy volunteer
Any race
Estimated glomerular filtration rate greater than 90 ml/min/1.73m2
Urine albumin/creatinine ratio less than 30mg/g
Disqualifiers
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
Design model
Crossover
Treatments tested in this trial
Vitamin B3
Dietary supplement1000mg once a day orally for two days, once the day before the exercise session, and once the day of the exercise session.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Vitamin B3, then placeboExperimental treatment 1 intervention
Group B: Placebo, then vitamin B3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Urinary neutrophil gelatinase-associated lipocalin
Marker of stress and injury in the kidney
Time frame
Pre- and immediately post- heat stress exposure2
Urinary TIMP2 (tissue inhibitor of metalloproteinase-2) and IGFBP7 (insulin-like growth factor-binding protein 7)
Marker of kidney stress and injury
Time frame
Pre- and immediately post- heat stress exposureSecondary outcomes
1
Urine Quinolinate to Tryptophan Ratio
Ratio of quinolinate to tryptophan in the urine
Time frame
Pre- and immediately post- heat stress exposure2
Serum creatinine
Marker of kidney function
Time frame
Pre- and immediately post- heat stress exposureOther outcomes
1
Urine and serum metabolites, including metabolites related to nicotinamide adenine dinucleotide (NAD+)
Other chemical byproducts of metabolism and exposure that may change during or impact the effect of heat stress, measured using mass spectrometry
Time frame
Pre-, during, immediately post, and 24 hours post- heat stress exposure2
Urine and serum nicotinamide levels
Levels of the interventional supplement, vitamin B3 (nicotinamide)
Time frame
Pre-, during, immediately post, and 24 hours post- heat stress exposureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beth Israel Deaconess Medical Center
Lead sponsor
Boston University Charles River Campus
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov