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TerminatedNCT00808925Updated Dec 19, 2013

The Impact of Heat Acclimation on Pro- and Anti- Inflammatory Cytokine Response

An interventional study of exposure to heat in "Exposure to Heat", sponsored by Prof. Yoram Epstein. Terminated at 1 site in Israel. Open to male participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-19.

Sponsored by Prof. Yoram Epstein · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 25 Years
Sex
Male
01

Study summary

There is growing evidence to conclude that part of the cascade leading to heatstroke is related to an inflammatory reaction triggered by the heat stress. The reduced ability to sustain heat stress - "heat intolerance" is also attributed to over-expression of inflammatory cytokines. Acclimation to heat improves human sustainability to heat and is a leading protective factor against heat stroke. The investigators hypothesize that the lower stress encountered during the process of acclimation to heat will be reflected by an over-ride in the expression of anti-inflammatory over the pro-inflammatory cytokines. This, in turn will attenuate the pathological cascade leading to heat stroke.

02

Conditions studied

  • "Exposure to Heat"

Keywords

  • acclimation
  • heat
  • cytokines
  • stress
  • inflammation
03

In context

Lead sponsor

This is the only study on the registry with Prof. Yoram Epstein as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • age:18-25
  • medically screened (healthy)

Exclusion criteria

Exclusion Criteria:

  • BMI over 22 kg/m2
  • systolic blood pressure over 120 mmHg
  • any febrile illness during the last week preceding the study
  • any skin disease
  • diabetes
  • any heart conditions.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    research arm

    Other: exposure to heat

Interventions

  • Otherexposure to heat

    Dressed in shorts and tennis shoes the subjects will be exposed to exercise-heat stress for 12 consecutive days (excluding Saturday). Daily exposure will last 120 min, under the controlled environmental conditions of 40oC and 40% relative humidity. The exercise will consist of walking on a treadmill at a pace of 5km/h and 2% incline.

    Also known as: acclimation to heat

06

What researchers measure

Primary outcomes

  1. Investigating the variability in the levels of different cytokine and the kinetics in cytokine levels during the process of acclimation to heat.

    Time frame: 12 days

07

Study locations

1 site
  • Heller Institute of Medical Reachearch, Sheba Medical Center
    Tel Hashomer, 52621, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00808925
Lead sponsor
Prof. Yoram Epstein
Collaborators
Medical Corps, Israel Defense Force
Responsible party
Prof. Yoram Epstein (Heller institue, Sheba Medical Center, Sheba Medical Center) — Sponsor-investigator
First posted
Dec 16, 2008
Start date
Jan 2009
Primary completion
Apr 2013
Completion
Jul 2013
Last update
Dec 19, 2013

Study contacts

Daniel S Moran, PhD
study director · Institute of Military Physiology, IDF Medical Corps

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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