At a glance

ClinicalIndex Comparison Record

N/ACompleted· 555 enrolled

Drug / intervention

Phospholipid-bound omega-3 supplement +1 moredietary

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02908932

NCT02908932N/ACompleted

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Ranger Resilience and Improved Performance on Phospholipid Bound Omega-3's

Medical University of South Carolina·interventional·Posted Sep 21, 2016·Updated Jul 5, 2018

In Brief

A clinical study evaluating Phospholipid-bound omega-3 supplement and Placebo supplement for Nutrition and 4 related conditions. Completed, enrolled 555 participants across 3 sites.

Detailed Summary

The goal of this study is to determine if supplementation with krill oil concentrate containing the phospholipid-bound omega-3 fatty acids improves performance on specific cognitive tests that underlie key elements in U.S. Army Infantry Basic Officer Leaders Course (IBOLC) and in Ranger School (Training) at Fort Benning, Georgia (GA).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsNutrition, Fatty Acids, Omega-3, Cognition, Resilience, Psychological, Psychology, Military

CountriesUnited States

CollaboratorsAker BioMarine Human Ingredients AS

Timeline

N/ACompletedFinished

2017201820192020202120222023202420252026

Enrollment StartAug 2016

First PostedSep 2016

Primary CompletionJun 2018

TodayJul 2026

First PostedSep 21, 2016

Enrollment StartAug 1, 2016

Primary CompletionJun 1, 2018

TodayJul 2, 2026

Enrollment to primary: 1.8 yearsPosted 9.8 years ago

Interventions

Phospholipid-bound omega-3 supplementdietary

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 supplementdietary

Placebo capsules that are identical in size and color to the experimental but contain an equal amount of macadamia nut oil.