Laboratory Heat Biomarker and Cooling Interventions
23 de mayo de 2026 actualizado por: Julie Parsonnet, Stanford University
Laboratory Based Identification of Heat Stress Biomarkers and Effective Cooling Interventions
Our study has two goals. The first goal is to find a blood test that can detect signs of strain from heat in the body ("a biomarker"). Second, the study team wants to identify types of devices that can help people cool down quickly.
By identifying biomarkers for heat strain, scientists can better track and treat the health effects of heat. The study team will identify such biomarkers by simulating, in a laboratory-based environment, the heat and physical work that real-world workers experience.
In addition, the study team plans to test two cooling technologies that might keep people cool during physical activity.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
California
-
Stanford, California, Estados Unidos, 94305
- Stanford University
-
Contacto:
- Astrid Elliott, MS
- Correo electrónico: astride@stanford.edu
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Age 18-50
- Able to communicate in English or Spanish
- General good health
- A lifestyle that includes regular patterns of modest exercise
- Body weight over 80 pounds
Exclusion Criteria:
- Cannot provide informed consent
- Known history of cardiac arrhythmias or having a pacemaker
- Difficulty swallowing pills
- Planned upcoming X-ray tests or MRI
- Known history of gastroparesis, diverticulosis or diverticulitis, or inflammatory bowel disease
- Previous surgery on stomach or intestines (except for appendix or gallbladder)
- Pregnancy
- Self-reported cardiac, kidney, or pulmonary disease, or diabetes
- Concurrent use of temperature- or inflammation-modulating medications such as steroids or non-steroidal anti-inflammatory drugs (NSAIDs)
- Staff under the direct supervision of any project directors or employed in the laboratory of the study investigators
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Biomarker testing (A), Cooling bandana (B), Hand cooling table (C)
On day 1 participants use the treadmill for one hour at a research laboratory while being monitored by trained research personnel and no cooling intervention is given to the participants.
On day 2, participants use a cooling bandana during exercise for 1 hour.
On day 3, participants use a hand cooling table after exercise for 10 minutes during a recovery period.
|
A participant can rest their hand on the cooling table after the one hour exercise session, and this should cool their body quickly.
Cold water is pumped throughout the cooling table.
A participant will tie a bandana that has been soaked in cold water onto their forehead.
They will wear this bandana during the one hour exercise session.
|
|
Experimental: Biomarker testing (A), Hand cooling table (C), Cooling bandana (B)
On day 1 participants use the treadmill for one hour at a research laboratory while being monitored by trained research personnel and no cooling intervention is given to the participants.
On day 2, participants use a hand cooling table after exercise for 10 minutes during a recovery period.
On day 3, participants use a cooling bandana during exercise for 1 hour.
|
A participant can rest their hand on the cooling table after the one hour exercise session, and this should cool their body quickly.
Cold water is pumped throughout the cooling table.
A participant will tie a bandana that has been soaked in cold water onto their forehead.
They will wear this bandana during the one hour exercise session.
|
|
Experimental: Cooling bandana (B), Biomarker testing (A), Hand cooling table (C)
On day 1, participants use a cooling bandana during exercise for 1 hour at a research laboratory while being monitored by trained research personnel.
On day 2 participants use the treadmill for one hour and no cooling intervention is given to the participants.
On day 3, participants use a hand cooling table after exercise for 10 minutes during a recovery period.
|
A participant can rest their hand on the cooling table after the one hour exercise session, and this should cool their body quickly.
Cold water is pumped throughout the cooling table.
A participant will tie a bandana that has been soaked in cold water onto their forehead.
They will wear this bandana during the one hour exercise session.
|
|
Experimental: Cooling bandana (B), Hand cooling table (C), Biomarker testing (A)
On day 1, participants use a cooling bandana during exercise for 1 hour at a research laboratory while being monitored by trained research personnel.
On day 2, participants use a hand cooling table after exercise for 10 minutes during a recovery period.
On day 3 participants use the treadmill for one hour and no cooling intervention is given to the participants.
|
A participant can rest their hand on the cooling table after the one hour exercise session, and this should cool their body quickly.
Cold water is pumped throughout the cooling table.
A participant will tie a bandana that has been soaked in cold water onto their forehead.
They will wear this bandana during the one hour exercise session.
|
|
Experimental: Hand cooling table (C), Biomarker testing (A), Cooling bandana (B)
On day 1, participants use a hand cooling table after exercise for 10 minutes during a recovery period at a research laboratory while being monitored by trained research personnel.
On day 2 participants use the treadmill for one hour and no cooling intervention is given to the participants.
On day 3, participants use a cooling bandana during exercise for 1 hour.
|
A participant can rest their hand on the cooling table after the one hour exercise session, and this should cool their body quickly.
Cold water is pumped throughout the cooling table.
A participant will tie a bandana that has been soaked in cold water onto their forehead.
They will wear this bandana during the one hour exercise session.
|
|
Experimental: Hand cooling table (C), Cooling bandana (B), Biomarker testing (A)
On day 1, participants use a hand cooling table after exercise for 10 minutes during a recovery period at a research laboratory while being monitored by trained research personnel.
On day 2, participants use a cooling bandana during exercise for 1 hour.
On day 3 participants use the treadmill for one hour and no cooling intervention is given to the participants.
|
A participant can rest their hand on the cooling table after the one hour exercise session, and this should cool their body quickly.
Cold water is pumped throughout the cooling table.
A participant will tie a bandana that has been soaked in cold water onto their forehead.
They will wear this bandana during the one hour exercise session.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Core body temperature
Periodo de tiempo: Baseline through end of study (approximately 2 months).
|
Baseline through end of study (approximately 2 months).
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Julie Parsonnet, MD, Stanford University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Grahn DA, Cao VH, Heller HC. Heat extraction through the palm of one hand improves aerobic exercise endurance in a hot environment. J Appl Physiol (1985). 2005 Sep;99(3):972-8. doi: 10.1152/japplphysiol.00093.2005. Epub 2005 May 5.
- Mishra J, Ma Q, Prada A, Mitsnefes M, Zahedi K, Yang J, Barasch J, Devarajan P. Identification of neutrophil gelatinase-associated lipocalin as a novel early urinary biomarker for ischemic renal injury. J Am Soc Nephrol. 2003 Oct;14(10):2534-43. doi: 10.1097/01.asn.0000088027.54400.c6.
- Shen X, Kellogg R, Panyard DJ, Bararpour N, Castillo KE, Lee-McMullen B, Delfarah A, Ubellacker J, Ahadi S, Rosenberg-Hasson Y, Ganz A, Contrepois K, Michael B, Simms I, Wang C, Hornburg D, Snyder MP. Multi-omics microsampling for the profiling of lifestyle-associated changes in health. Nat Biomed Eng. 2024 Jan;8(1):11-29. doi: 10.1038/s41551-022-00999-8. Epub 2023 Jan 19.
- Hymczak H, Golab A, Mendrala K, Plicner D, Darocha T, Podsiadlo P, Hudziak D, Gocol R, Kosinski S. Core Temperature Measurement-Principles of Correct Measurement, Problems, and Complications. Int J Environ Res Public Health. 2021 Oct 10;18(20):10606. doi: 10.3390/ijerph182010606.
- Ray SC, Mason J, O'Connor PM. Ischemic Renal Injury: Can Renal Anatomy and Associated Vascular Congestion Explain Why the Medulla and Not the Cortex Is Where the Trouble Starts? Semin Nephrol. 2019 Nov;39(6):520-529. doi: 10.1016/j.semnephrol.2019.10.002.
- Evans RG, Smith DW, Lee CJ, Ngo JP, Gardiner BS. What Makes the Kidney Susceptible to Hypoxia? Anat Rec (Hoboken). 2020 Oct;303(10):2544-2552. doi: 10.1002/ar.24260. Epub 2019 Sep 30.
- Febbraio MA. Alterations in energy metabolism during exercise and heat stress. Sports Med. 2001;31(1):47-59. doi: 10.2165/00007256-200131010-00004.
- Mazloumi A, Golbabaei F, Mahmood Khani S, Kazemi Z, Hosseini M, Abbasinia M, Farhang Dehghan S. Evaluating Effects of Heat Stress on Cognitive Function among Workers in a Hot Industry. Health Promot Perspect. 2014 Dec 30;4(2):240-6. doi: 10.5681/hpp.2014.031. eCollection 2014.
- Yin B, Fang W, Liu L, Guo Y, Ma X, Di Q. Effect of extreme high temperature on cognitive function at different time scales: A national difference-in-differences analysis. Ecotoxicol Environ Saf. 2024 Apr 15;275:116238. doi: 10.1016/j.ecoenv.2024.116238. Epub 2024 Mar 21.
- Alahmad B, Kessler W, Alwadi Y, Schwartz J, Wagner GR, Michaels D. A nationwide analysis of heat and workplace injuries in the United States. Environ Health. 2025 Oct 6;24(1):65. doi: 10.1186/s12940-025-01231-1.
- McTavish RK, Richard L, McArthur E, Shariff SZ, Acedillo R, Parikh CR, Wald R, Wilk P, Garg AX. Association Between High Environmental Heat and Risk of Acute Kidney Injury Among Older Adults in a Northern Climate: A Matched Case-Control Study. Am J Kidney Dis. 2018 Feb;71(2):200-208. doi: 10.1053/j.ajkd.2017.07.011. Epub 2017 Oct 23.
- Moyce S, Armitage T, Mitchell D, Schenker M. Acute kidney injury and workload in a sample of California agricultural workers. Am J Ind Med. 2020 Mar;63(3):258-268. doi: 10.1002/ajim.23076. Epub 2019 Nov 26.
- Grahn DA, Murray JV, Heller HC. Cooling via one hand improves physical performance in heat-sensitive individuals with multiple sclerosis: a preliminary study. BMC Neurol. 2008 May 12;8:14. doi: 10.1186/1471-2377-8-14.
- Lissoway JB, Lipman GS, Grahn DA, Cao VH, Shaheen M, Phan S, Weiss EA, Heller HC. Novel application of chemical cold packs for treatment of exercise-induced hyperthermia: a randomized controlled trial. Wilderness Environ Med. 2015 Jun;26(2):173-9. doi: 10.1016/j.wem.2014.11.006. Epub 2015 Mar 12.
- Grahn DA, Cao VH, Nguyen CM, Liu MT, Heller HC. Work volume and strength training responses to resistive exercise improve with periodic heat extraction from the palm. J Strength Cond Res. 2012 Sep;26(9):2558-69. doi: 10.1519/JSC.0b013e31823f8c1a.
- Grahn D, Makam M, Craig Heller H. A method to reduce heat strain while clad in encapsulating outerwear. J Occup Environ Hyg. 2018 Aug;15(8):573-579. doi: 10.1080/15459624.2018.1470635.
- Kellogg RA, Dunn J, Snyder MP. Personal Omics for Precision Health. Circ Res. 2018 Apr 27;122(9):1169-1171. doi: 10.1161/CIRCRESAHA.117.310909.
- Kregel KC. Heat shock proteins: modifying factors in physiological stress responses and acquired thermotolerance. J Appl Physiol (1985). 2002 May;92(5):2177-86. doi: 10.1152/japplphysiol.01267.2001.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de junio de 2028
Finalización del estudio (Estimado)
1 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
23 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 86182
- 1R01DK146310-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .