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De klinische studie NCT06983730 voor Heat Strain, Studie met gezonde vrijwilligers, Nierdisfunctie is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
The Kidney's Response to Exercise in Heat, and the Impact of Vitamin B3 on This Response
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De klinische studie NCT06983730 onderzoekt basiswetenschap bij Heat Strain, Studie met gezonde vrijwilligers, Nierdisfunctie. Deze Vroege fase 1 interventioneel studie heeft de status nog niet rekruterend. De inclusie van 28 deelnemers begint op 1 december 2025. De studie wordt geleid door Beth Israel Deaconess Medical Center en de voltooiing is gepland op 1 oktober 2027. Laatste update op ClinicalTrials.gov: 28 oktober 2025.
Beknopte samenvatting
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?
Uitgebreide beschrijving
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
Officiële titel
Development of a Clinical Experimental Heat Stress Protocol and Exploration of the Effect of Niacinamide on Physiologic, Metabolic, and Biochemical Responses to Heat Stress
Aandoeningen
Heat StrainStudie met gezonde vrijwilligersNierdisfunctieAndere studie-ID's
- 2024P000637
- K23DK138320 (Subsidie/contract van NIH (VS))
NCT-ID
Startdatum (Werkelijk)
2025-12
Laatste update geplaatst
2025-10-28
Verwachte einddatum
2027-10
Inschrijving (Geschat)
28
Studietype
Interventioneel
FASE
Vroege fase 1
Status
Nog niet rekruterend
Trefwoorden
NAD+
Niacinamide
Vitamin B3
Experimental heat strain
Niacinamide
Vitamin B3
Experimental heat strain
Primaire doel
Basiswetenschap
Toewijzing
Gerandomiseerd
Interventiemodel
Cross-over
Blindering
Viervoudig blind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelVitamin B3, then placebo Individuals will receive 1000mg oral Vitamin B3 daily for 2 days leading up to their first exercise session, and oral placebo daily for 2 days leading up to their second exercise session. | 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. |
ExperimenteelPlacebo, then vitamin B3 Individuals will receive 1000mg oral placebo daily for 2 days leading up to their first exercise session, and oral vitamin B3 daily for 2 days leading up to their second exercise session. | 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. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Urinary neutrophil gelatinase-associated lipocalin | Marker of stress and injury in the kidney | Pre- and 1 hour post- heat stress exposure |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Urine Quinolinate to Tryptophan Ratio | Ratio of quinolinate to tryptophan in the urine | Pre- and 1 hour post- heat stress exposure |
Serum creatinine | Marker of kidney function | Pre- and 1 hour post- heat stress exposure |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
- 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
- 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
Beth Israel Deaconess Medical Center- Universiteit van Boston280 actieve klinische studies om te verkennen
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verantwoordelijke instantie
Nathan Raines, Hoofdonderzoeker, Instructor in Medicine, Beth Israel Deaconess Medical Center
Centraal Contactpersoon
Contact: Nathan H Raines, MD MPH, 703-927-0992, [email protected]
2 Studielocaties in 1 landen
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States
Nathan H Raines, MD MPH, Contact, 703-927-0992, [email protected]
Nathan H Raines, MD MPH, Hoofdonderzoeker
Boston University, Boston, Massachusetts, 02215, United States
Dustin Allen, PhD, Contact, 417-693-2182, [email protected]
Dustin Allen, PhD, Hoofdonderzoeker