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

Sheba Medical Center

Status: Unknown

Conditions: Body Temperature Regulation

Treatments: Drug: Astaxanthin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02088242

SHEBA-13-0471-BA-CTIL

IDF-1295-2013 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: Male

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Astaxanthin

Experimental group

Description:

Subjects receiving Astaxanthin will be asked to ingest 3 capsules containing 4mg of Astaxanthin each (a daily dose of 12mg).

Treatment:

Drug: Astaxanthin