Physiological and Molecular Influences of Astaxanthin Supplementation on Heat Strain in Humans
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Sheba Medical Center
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Physiological strain
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 30 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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: Placebo (Drug)
Astaxanthin
Subjects receiving Astaxanthin will be asked to ingest 3 capsules containing 4mg of Astaxanthin each (a daily dose of 12mg).
Intervention: Astaxanthin (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Rectal temperature(2 months for each participant)
- Skin temperature(2 months for each participant)
- Heart rate(2 months for each participant)
- Sweat rate(2 months for each participant)
- Cognitive function(2 months for each participant)
Investigators
Dr. Ofir Frenkel MD
head investigator of Heller institute of physiology
Sheba Medical Center