Laboratory Heat Biomarker and Cooling Interventions

NCT07617649 | Not Yet Recruiting DMC

• 2 other identifiers: 861821R01DK146310-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperthermia

Outcome Measures

Primary Outcomes (1)

• Core body temperature

  Baseline through end of study (approximately 2 months).

Study Arms (6)

Biomarker testing (A), Cooling bandana (B), Hand cooling table (C)

EXPERIMENTAL

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.

Other: Hand cooling table; Other: Cooling bandana

Biomarker testing (A), Hand cooling table (C), Cooling bandana (B)

EXPERIMENTAL

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.

Other: Hand cooling table; Other: Cooling bandana

Cooling bandana (B), Biomarker testing (A), Hand cooling table (C)

EXPERIMENTAL

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.

Other: Hand cooling table; Other: Cooling bandana

Cooling bandana (B), Hand cooling table (C), Biomarker testing (A)

EXPERIMENTAL

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.

Other: Hand cooling table; Other: Cooling bandana

Hand cooling table (C), Biomarker testing (A), Cooling bandana (B)

EXPERIMENTAL

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.

Other: Hand cooling table; Other: Cooling bandana

Hand cooling table (C), Cooling bandana (B), Biomarker testing (A)

EXPERIMENTAL

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.

Other: Hand cooling table; Other: Cooling bandana

Interventions

Hand cooling table OTHER

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.

Biomarker testing (A), Cooling bandana (B), Hand cooling table (C); Biomarker testing (A), Hand cooling table (C), Cooling bandana (B); Cooling bandana (B), Biomarker testing (A), Hand cooling table (C); Cooling bandana (B), Hand cooling table (C), Biomarker testing (A); Hand cooling table (C), Biomarker testing (A), Cooling bandana (B); Hand cooling table (C), Cooling bandana (B), Biomarker testing (A)

Cooling bandana OTHER

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.

Biomarker testing (A), Cooling bandana (B), Hand cooling table (C); Biomarker testing (A), Hand cooling table (C), Cooling bandana (B); Cooling bandana (B), Biomarker testing (A), Hand cooling table (C); Cooling bandana (B), Hand cooling table (C), Biomarker testing (A); Hand cooling table (C), Biomarker testing (A), Cooling bandana (B); Hand cooling table (C), Cooling bandana (B), Biomarker testing (A)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (18)

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MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Julie Parsonnet, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: George DeForest Barnett Professor of Medicine, Emerita

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)