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

NCT02908932 | Completed DMC

• 1 other identifier: Pro00051532
• Study Type: interventional
• Target: 555
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (6)

• Change (vs. baseline) in Inhibition and Rule-Making

  Stroop

  baseline, week 14, week 16, within 72 hours of ending Ranger training

• Change (vs. baseline) in psychological resiliency

  Connor-Davidson Resilience Scale (CD-RISC)

  baseline, week 14, week 16, within 72 hours of ending Ranger training

• Group differences on Land Navigation scores (from IBOLC gradebook)

  Land navigation tests the ability of candidates to navigate from one point to another using a map and compass while equipped with their individual combat gear.

  data collected by Army throughout 5 months of IBOLC training and scores summed at the end of 5 months and provided to study pi

• Group differences on Marksmanship scores (from IBOLC gradebook)

  The underlying construct, visual psychomotor control, is assessed by evaluating whether "Marksman" or higher ranking was achieved on first attempt.

  data collected by Army throughout 5 months of IBOLC training and scores summed at the end of 5 months and provided to study pi

• Change (vs. baseline) in Focused Attention and Information processing speed

  Digit-Symbol Coding

  baseline, week 14, week 16, within 72 hours of ending Ranger training

• Change (vs. baseline) in physiological resiliency

  Composite score from Patient Reported Outcomes Measurement Information System (PROMIS), v. 1.0 for Applied Cognition, Fatigue, \& Sleep-related impairment

  baseline, week 14, week 16, within 72 hours of ending Ranger training

Secondary Outcomes (7)

• Change (vs. baseline) in Working Memory

  baseline, week 14, week 16,within 72 hours of ending Ranger training

• Anxiety as a Measure of Psychological Functioning

  baseline, week 14, week 16, within 72 hours of ending Ranger training

• Stress Response

  within 72 hours of ending Ranger training

• Mood State as a measure of Psychological Functioning

  baseline, week 14, week 16, within 72 hours of ending Ranger training

• Change (vs. baseline) in Reasoning

  baseline, week 14, week 16, within 72 hours of ending Ranger training

Study Arms (2)

Phospholipid-bound omega-3 supplement

EXPERIMENTAL

2.3g/d omega-3 HUFAs (with the EPA to DHA ratio of approximately 2:1), delivered in 8 capsules/day in Krill oil concentrates (Aker BioMarine Antarctic AS, Norway). Participants will receive supplements for the duration of IBOLC (19 weeks) and up until entry in Ranger. Time between completion of IBOLC and entry in Ranger is variable, ranging from 1 weeks to 10 weeks (4 weeks typical). Total duration on supplement thus ranges from 20 to 30 weeks.

Dietary Supplement: Phospholipid-bound omega-3 supplement

Placebo supplement

PLACEBO COMPARATOR

Matching placebo capsules, substituting macadamia nut oil and appropriate colorant for krill oil. Macadamia nut oil has not been associated with psychological, cognitive, or health benefits. Furthermore, it is not typically consumed in large quantities and is therefore useful in tracking blood serum levels to assess compliance within the placebo arm. Placebo capsules have been produced by Aker Biomarine. As with the experimental arm, participants will take 8 capsules daily for the duration of the study (20-30 weeks).

Dietary Supplement: Placebo supplement

Interventions

Phospholipid-bound omega-3 supplement DIETARY_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.

Phospholipid-bound omega-3 supplement

Placebo supplement DIETARY_SUPPLEMENT

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

Placebo supplement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Entry into IBOLC
• No self-reported previous injuries that would impede potential physical performance success in IBOLC or Ranger training

You may not qualify if:

• Infection, autoimmune disease, or fever of unknown origin
• Coronary Heart Disease
• History of seizures, except for febrile seizures during childhood
• Known allergy to crustaceans (shellfish) or nuts
• Vegetarian food preference.
• Regular use of omega-3 containing supplements within the last 3 months.
• Reported consumption of seafood three or more times per week within the last three months.
• Carry diagnosis of Type I or Type II diabetes
• Take hypoglycemic agents
• Refusal to stop taking specific dietary supplements pertinent to the study with the exception of standard multivitamins during study participation
• For women, pregnancy or intention to become pregnant during the potential study duration

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Aker BioMarine Human Ingredients AS: collaborator

Study Sites (3)

US Army, Fort Benning

Fort Benning, Georgia, 31905, United States

Location

National Institutes of Health

Bethesda, Maryland, 20892, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (33)

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Study Officials

• Bernadette P Marriott, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Travis H Turner, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Joseph R Hibbeln, MD

  LMBB, NIAAA, NIH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 21, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 5, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)