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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00808925
First Posted: December 16, 2008
Last Update Posted: December 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medical Corps, Israel Defense Force
Information provided by (Responsible Party):
Prof. Yoram Epstein, Sheba Medical Center
  Purpose
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.

Condition Intervention
"Exposure to Heat" Other: exposure to heat

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: The Impact of Heat Acclimation on Pro- and Anti- Inflammatory Cytokine Response

Further study details as provided by Prof. Yoram Epstein, Sheba Medical Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: January 2009
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: research arm Other: exposure 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.
Other Name: acclimation to heat

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808925


Locations
Israel
Heller Institute of Medical Reachearch, Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Prof. Yoram Epstein
Medical Corps, Israel Defense Force
Investigators
Study Director: Daniel S Moran, PhD Institute of Military Physiology, IDF Medical Corps
  More Information

Responsible Party: Prof. Yoram Epstein, Heller institue, Sheba Medical Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00808925     History of Changes
Other Study ID Numbers: SHEBA-08-5524-YE-CTIL
First Submitted: December 15, 2008
First Posted: December 16, 2008
Last Update Posted: December 19, 2013
Last Verified: December 2013

Keywords provided by Prof. Yoram Epstein, Sheba Medical Center:
acclimation
heat
cytokines
stress
inflammation

Additional relevant MeSH terms:
Anti-Inflammatory Agents