Laboratory Heat Biomarker and Cooling Interventions
23. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Stanford, California, Forente stater, 94305
- Stanford University
-
Ta kontakt med:
- Astrid Elliott, MS
- E-post: astride@stanford.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Core body temperature
Tidsramme: Baseline through end of study (approximately 2 months).
|
Baseline through end of study (approximately 2 months).
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Julie Parsonnet, MD, Stanford University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. juni 2028
Studiet fullført (Antatt)
1. juni 2028
Datoer for studieregistrering
Først innsendt
23. mai 2026
Først innsendt som oppfylte QC-kriteriene
23. mai 2026
Først lagt ut (Faktiske)
1. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 86182
- 1R01DK146310-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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