555
Participants
Start Date
August 31, 2016
Primary Completion Date
June 30, 2018
Study Completion Date
June 30, 2018
Phospholipid-bound omega-3 supplement
The dietary supplement is produced by Aker BioMarine. These krill oil capsules received a GRAS status approval from the U.S. Food and Drug Administration (FDA) in 2010. Aker BioMarine has a new pending application (2015) with the U.S. FDA for GRAS status for its new product on which this study capsule is based. Aker BioMarine markets a number of different krill-based omega-3 supplement products in the U.S. The US Food and Drug Administration (FDA) has determined that an Investigator New Drug (IND) Application is not required for this study. This phospholipid-bound omega-3 dietary supplement is provided in capsule form.
Placebo supplement
Placebo capsules that are identical in size and color to the experimental but contain an equal amount of macadamia nut oil.
National Institutes of Health, Bethesda
Medical University of South Carolina, Charleston
US Army, Fort Benning, Fort Benning
Aker BioMarine Human Ingredients AS
INDUSTRY
Medical University of South Carolina
OTHER