Toxicity and Safety Evaluation of an Omega-3 Fatty Acid and a Multivitamin and Antioxidant Nutritional Preparation
Recruitment status was Active, not recruiting
To evaluate the safety and tolerability of two supplements in healthy subjects taken daily for six months.
Effect of Nutritional Supplements on Healthy Volunteers.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Toxicity and Safety Evaluation of an Omega-3 Fatty Acid and a Multivitamin and Antioxidant Nutritional Preparation|
Blood samples will be drawn at baseline and three months to monitor hematology, blood chemistry, and urinalysis values for major changes. CBC, Chem-17, uric acid, lipid panel, PT/PTT, and urinalysis will be evaluated under fasting conditions.
|Study Start Date:||October 2010|
ACTIVE VITAMIN; PLACEBO OMEGA MAX
ACTIVE VITAMIN; ACTIVE OMEGA MAX
PLACEBO VITAMIN; ACTIVE OMEGA MAX
PLACEBO VITAMIN; PLACEBO OMEGA MAX
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221714
|United States, Mississippi|
|Mississippi Family Doctors|
|Pearl, Mississippi, United States, 39208|
|United States, North Carolina|
|Carolina Medical Associates|
|Charlotte, North Carolina, United States, 28226|
|United States, West Virginia|
|Logan General Hospital|
|Logan, West Virginia, United States, 25601|
|Principal Investigator:||Carlos Montesinos||AmeriSciences LP|