Laboratory Heat Biomarker and Cooling Interventions
23 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
California
-
Stanford, California, États-Unis, 94305
- Stanford University
-
Contact:
- Astrid Elliott, MS
- E-mail: astride@stanford.edu
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Core body temperature
Délai: Baseline through end of study (approximately 2 months).
|
Baseline through end of study (approximately 2 months).
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Julie Parsonnet, MD, Stanford University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 juin 2028
Achèvement de l'étude (Estimé)
1 juin 2028
Dates d'inscription aux études
Première soumission
23 mai 2026
Première soumission répondant aux critères de contrôle qualité
23 mai 2026
Première publication (Réel)
1 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 86182
- 1R01DK146310-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .