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
| Type | Name | Description |
|---|---|---|
| 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). |
| DRUG | Placebo | 3 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.