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Physiological and Molecular Influences of Astaxanthin Supplementation on Heat Strain in Humans (Astaxanthin)

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ClinicalTrials.gov Identifier: NCT02088242
Recruitment Status : Unknown
Verified March 2014 by Dr. Ofir Frenkel MD, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 14, 2014
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Ofir Frenkel MD, Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE March 3, 2014
First Posted Date  ICMJE March 14, 2014
Last Update Posted Date March 14, 2014
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2014)
  • Physiological strain [ Time Frame: 2 months for each participant ]
    The physiological strain will be determined by monitoring body core temperature and heart rate of the subjects during a heat tolerance test (HTT) and a thermo-neutral test (TTT).The test is performed in a climatic chamber. During the test, the subject walks on a treadmill at a speed of 5 km/hr at a 2% grade for 2h. Body core temperature and heart rate are continuously monitored, and sweat rate is computed from body weight prior to and after the test, corrected for fluid intake.
  • Aerobic capacity [ Time Frame: 2 months for each participant ]
    The aerobic capacity of the subjects will be determined by performing a maximal oxygen consumption test (VO2max). Volunteer's oxygen consumption (VO2) will be monitored continuously with a metabolic chart (ZAN- the name of the metabolic system), while running for 10 min on a treadmill under comfortable environmental conditions.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2014)
  • Rectal temperature [ Time Frame: 2 months for each participant ]
    The rectal temperature will be monitored by a rectal thermistor during each heat tolerance test (HTT) and thermo-neutral test (TTT) and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system (Biopac is the company in which the monitoring system was made).
  • Skin temperature [ Time Frame: 2 months for each participant ]
    The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg) and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.
  • Heart rate [ Time Frame: 2 months for each participant ]
    The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
  • Sweat rate [ Time Frame: 2 months for each participant ]
    Sweat rate will be calculated from the patients' body weight and fluid balance.
  • Cognitive function [ Time Frame: 2 months for each participant ]
    Cognitive function will be assessed using a cognitive testing software on laptop computers before and after performing the physiological tests.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiological and Molecular Influences of Astaxanthin Supplementation on Heat Strain in Humans
Official Title  ICMJE Physiological and Molecular Influences of Astaxanthin Supplementation on Heat Strain in Humans
Brief Summary Exposure to heat stress can compromise the physiological and cognitive function and be life threatening, particularly in a military setting. Various strategies of precondition to heat stress that have been explored in the past proved to be inapplicable. We aim to examine the influences of Astaxanthin supplementation as a preconditioning strategy to heat stress in a human model using a heat tolerance test. This will be achieved by a double-blind, placebo controlled supplementation trial, exposing human subjects, before and after consuming Astaxanthin or a placebo, to a controlled heat strain environment, while performing moderate exercise in a heated chamber.
Detailed Description

34 young, healthy civilian volunteers will participate in this study. After reading and signing an informed consent form, all subjects will undergo medical examination and an interview with a nutritionist to assess their dietary intake of Astaxanthin. They will then undergo 3 days of training on the cognitive testing software.

During the first stage, while consuming an Astaxanthin free diet, the subjects will participate in the physiological tests:heat tolerance test (HTT), thermo-neutral test (TTT) and maximal oxygen consumption test (VO2max) on 3 separate days.

During the second stage, the subjects will be randomly and blindly assigned to either the placebo or the Astaxanthin supplementation arms, and undergo 35-40 days of supplementation.

Physiological testing of the second stage will take place between the 31st and 35th (up to 40th - optional) days of supplementation and will include HTT, TTT and VO2max on 3 separate days.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Body Temperature Regulation
Intervention  ICMJE
  • Drug: Astaxanthin
    Oral supplementation with the food supplement Astaxanthin. Subjects receiving Astaxanthin will be asked to ingest 3 capsules containing 4mg of Astaxanthin each (a daily dose of 12mg).
  • Drug: Placebo
    3 capsules identical in shape, colour and size to the Astaxanthin capsules, which contain only the inactive ingredients of the same formulation.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Subjects receiving placebo will be asked to ingest 3 capsules identical in shape, colour and size to the Astaxanthin capsules, and will contain only the inactive ingredients of the same formulation.
    Intervention: Drug: Placebo
  • Experimental: Astaxanthin
    Subjects receiving Astaxanthin will be asked to ingest 3 capsules containing 4mg of Astaxanthin each (a daily dose of 12mg).
    Intervention: Drug: Astaxanthin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 12, 2014)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2015
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy civilian volunteers.
  • Aged 20-30 years.
  • Without known medical illness or medication use.

Exclusion Criteria:

  • The existence or suspicion of existing cardiac or respiratory disease.
  • Hypertension.
  • Diabetes.
  • Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
  • Infectious disease 3 days prior to the experiment.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02088242
Other Study ID Numbers  ICMJE SHEBA-13-0471-BA-CTIL
IDF-1295-2013 ( Other Identifier: IDF )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Ofir Frenkel MD, Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ofir Frenkel, M.D Sheba Medical Center
PRS Account Sheba Medical Center
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP