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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Body Temperature Regulation Drug: Astaxanthin Drug: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Physiological and Molecular Influences of Astaxanthin Supplementation on Heat Strain in Humans
Study Start Date : May 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Astaxanthin

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Placebo
3 capsules identical in shape, colour and size to the Astaxanthin capsules, which contain only the inactive ingredients of the same formulation.
Experimental: Astaxanthin
Subjects receiving Astaxanthin will be asked to ingest 3 capsules containing 4mg of Astaxanthin each (a daily dose of 12mg).
 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

  4. Sweat rate [ Time Frame: 2 months for each participant ]
    Sweat rate will be calculated from the patients' body weight and fluid balance.

  5. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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): NCT02088242


Contacts
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Contact: Ofir Frenkel, M.D +972529243399 Ofir.Frenkel@sheba.health.gov.il

Locations
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Israel
Sheba medical center
Tel-Hashomer, Ramat- Gan, Israel
Contact: Ofir Frenkel, M.D    +972529243399    Ofir.Frenkel@sheba.health.gov.il   
Principal Investigator: Ofir Frenkel, M.D         
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Ofir Frenkel, M.D Sheba Medical Center
More Information
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Responsible Party: Dr. Ofir Frenkel MD, head investigator of Heller institute of physiology, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02088242    
Other Study ID Numbers: SHEBA-13-0471-BA-CTIL
IDF-1295-2013 ( Other Identifier: IDF )
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: March 2014