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

NCT02908932 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2018-07-05

No results posted yet for this study

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).

Conditions

  • Nutrition
  • Fatty Acids, Omega-3
  • Cognition
  • Resilience, Psychological
  • Psychology, Military

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Placebo supplement

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

Sponsors & Collaborators

  • Aker BioMarine Human Ingredients AS

    collaborator INDUSTRY

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Bernadette P Marriott, PhD · Medical University of South Carolina

  • Travis H Turner, PhD · Medical University of South Carolina

  • Joseph R Hibbeln, MD · LMBB, NIAAA, NIH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02908932 on ClinicalTrials.gov