Healthy Clinical Trial
Official title:
Toxicity and Safety Evaluation of an Omega-3 Fatty Acid and a Multivitamin and Antioxidant Nutritional Preparation
To evaluate the safety and tolerability of two supplements in healthy subjects taken daily for six months.
The Lyndon B. Johnson Space Center (JSC) of the National Aeronautics and Space Administration
(NASA) and AmeriSciences have entered into a Space Act Agreement (1), the primary objectives
of which are the development of nutritional products in the form of dietary supplements to
maintain homeostasis, and as countermeasures to reduce the biological effects and damages of
long-duration spaceflight mediated through oxidative stress both in low Earth Orbit and
planetary exploration of the solar system, as well as to provide optimal nutritional
supplementation to aid in pre-spaceflight conditioning.
NASA has determined through pre-, in-, and post-flight assessment of cells, animals and
humans that spaceflight induces oxidative stress on crewmembers. There are multiple potential
sources of oxidative injury to include, but not limited to space radiation, noise, fuel
reaction products, planetary regolith, and exercise. Furthermore, NASA has also determined
that several foreseen and unforeseen physiological events can be controlled, avoided, or
encouraged by means of dietary modification through supplements. Due to unforeseen limitation
in the available fresh food supply for envisioned exploratory missions, it is desirable for
NASA to have nutritional supplementation available to provide crewmembers with augmentation
for the intrinsic defense systems against oxidative damage, as well as for potential
nutritional contingencies such as food shortages and optimization of the diet. NASA has
identified the need for specific micronutrient formulations to complement natural food
sources, for astronaut protection during long-duration space flight.
AmeriSciences is a nutritional company that specializes in science-based product formulation,
manufacturing under Good Manufacturing Practices (GMP) using standards modeled after those
used by the pharmaceutical industry. It has been charged with the co-development, aid,
clinical evaluation, construction, and production of said micronutrient formulations, to the
level of specifications required to meet NASA's expectations for safety and efficacy.
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