Laboratory Heat Biomarker and Cooling Interventions
Status
Not yet enrolling
Conditions
Hyperthermia
Treatments
Other: Cooling bandana
Other: Hand cooling table
Study type
Interventional
Funder types
Other
NIH
Identifiers
Details and patient eligibility
About
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.
Enrollment
30 estimated patients
Sex
All
Ages
18 to 50 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
30 participants in 6 patient groups
Biomarker testing (A), Cooling bandana (B), Hand cooling table (C)
Experimental group
Description:
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.
Treatment:
Other: Hand cooling table
Other: Cooling bandana
Biomarker testing (A), Hand cooling table (C), Cooling bandana (B)
Experimental group
Description:
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.
Treatment:
Other: Hand cooling table
Other: Cooling bandana
Cooling bandana (B), Biomarker testing (A), Hand cooling table (C)
Experimental group
Description:
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.
Treatment:
Other: Hand cooling table
Other: Cooling bandana
Cooling bandana (B), Hand cooling table (C), Biomarker testing (A)
Experimental group
Description:
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.
Treatment:
Other: Hand cooling table
Other: Cooling bandana
Hand cooling table (C), Biomarker testing (A), Cooling bandana (B)
Experimental group
Description:
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.
Treatment:
Other: Hand cooling table
Other: Cooling bandana
Hand cooling table (C), Cooling bandana (B), Biomarker testing (A)
Experimental group
Description:
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.
Treatment:
Other: Hand cooling table
Other: Cooling bandana
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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