76
Participants
Start Date
October 23, 2018
Primary Completion Date
August 21, 2021
Study Completion Date
August 21, 2021
AKBM-3031
"Krill are shrimp-like small crustaceans (up to 6 cm) found in all the world's oceans, but mostly in the Arctic and Antarctic polar seas. Krill are rich in the long-chain omega-3 polyunsaturated fatty acids or LC-PUFAs eicosapentaenoic acid (EPA, C20:5n3) and docosahexaenoic acid (DHA, C22:6n3). The lipid pool of krill is composed of phospholipids and triglycerides and the LC-PUFAs are primarily in the phospholipid fraction.~The product is produced under food Good Manufacturing Practice (GMP) regulations and has status as GRAS or Generally Recognized As Safe. GRAS is defined by the US Food and Drug Administration (FDA) as a substance that is generally recognized, among qualified experts, to be safe under the conditions of its intended use."
Placebo
The placebo will be provided in capsules looking exactly as the krill oil capsules and will contain a fatty acid mixture (olive oil, corn oil, palm oil and medium chain triglycerides) which has the same composition as the average European diet (26.0% C16:0, 4.6% C18:0, 35.8% C18:1n9, 16.7% C18:2n6, 2.1% C18:3n3, 0% C20:4n6 and 14.8% other compounds) and contains no EPA or DHA.
Hospital for Special Surgery, New York
Albert Einstein College of Medicine, The Bronx
Northwell Health, Great Neck
Feinstein Institute for Medical Research, Manhasset
University of Rochester Medical Center, Rochester
University of Maryland, Baltimore
Wake Forest Baptist Health, Winston-Salem
University of Miami, Miami
University of Alabama at Birmingham, Birmingham
University of Michigan Health System, Ann Arbor
Mayo Clinic, Rochester
Rush Medical Center, Chicago
Wallace Rheumatic Studies Center, LLC, Beverly Hills
UC Irvine Health, Orange
Brigham and Women's Hospital, Boston
Lupus Clinic-Mary Pack Arthritis Centre, Vancouver
McMaster University Medical Center, Hamilton
McGill University Health Centre-The Montreal General Hospital, Montreal
University of Laval, Québec
Ampel BioSolutions, LLC
INDUSTRY
Aker BioMarine Human Ingredients AS
INDUSTRY