Clinical trial NCT02088242: Physiological and Molecular Influences of Astaxanthin Supplementation on Heat Strain in Humans
Official title: Physiological and Molecular Influences of Astaxanthin Supplementation on Heat Strain in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Temperature Regulation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-03-14
Enrollment: 34
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Physiological strain
timeFrame: 2 months for each participant
measure: Aerobic capacity
timeFrame: 2 months for each participant
Secondary outcomes:
measure: Rectal temperature
timeFrame: 2 months for each participant
measure: Skin temperature
timeFrame: 2 months for each participant
measure: Heart rate
timeFrame: 2 months for each participant
measure: Sweat rate
timeFrame: 2 months for each participant
measure: Cognitive function
timeFrame: 2 months for each participant
Other outcomes:
Locations:
city: Tel-Hashomer, Ramat- Gan
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Sheba Medical Center
name: Ofir Frenkel, M.D
role: PRINCIPAL_INVESTIGATOR
References: