Clinical Trials Directory

Trials / Unknown

UnknownNCT02088242

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
34 (estimated)
Sponsor
Sheba Medical Center · Other Government
Sex
Male
Age
20 Years – 30 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAstaxanthinOral 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).
DRUGPlacebo3 capsules identical in shape, colour and size to the Astaxanthin capsules, which contain only the inactive ingredients of the same formulation.

Timeline

Start date
2014-05-01
Primary completion
2015-05-01
Completion
2015-08-01
First posted
2014-03-14
Last updated
2014-03-14

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT02088242. Inclusion in this directory is not an endorsement.