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Trial record 4 of 180 for:    Phospholipids

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02908932
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : July 4, 2018
Sponsor:
Collaborator:
Aker Biomarine Antarctic AS
Information provided by (Responsible Party):
Medical University of South Carolina

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).

Condition or disease Intervention/treatment Phase
Nutrition Fatty Acids, Omega-3 Cognition Resilience, Psychological Psychology, Military Dietary Supplement: Phospholipid-bound omega-3 supplement Dietary Supplement: Placebo supplement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 555 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Ranger Resilience and Improved Performance on Phospholipid Bound Omega-3's
Actual Study Start Date : August 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phospholipid-bound omega-3 supplement
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
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 Comparator: Placebo supplement
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
Placebo capsules that are identical in size and color to the experimental but contain an equal amount of macadamia nut oil.




Primary Outcome Measures :
  1. Change (vs. baseline) in Inhibition and Rule-Making [ Time Frame: baseline, week 14, week 16, within 72 hours of ending Ranger training ]
    Stroop

  2. Change (vs. baseline) in psychological resiliency [ Time Frame: baseline, week 14, week 16, within 72 hours of ending Ranger training ]
    Connor-Davidson Resilience Scale (CD-RISC)

  3. Group differences on Land Navigation scores (from IBOLC gradebook) [ Time Frame: data collected by Army throughout 5 months of IBOLC training and scores summed at the end of 5 months and provided to study pi ]
    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.

  4. Group differences on Marksmanship scores (from IBOLC gradebook) [ Time Frame: data collected by Army throughout 5 months of IBOLC training and scores summed at the end of 5 months and provided to study pi ]
    The underlying construct, visual psychomotor control, is assessed by evaluating whether "Marksman" or higher ranking was achieved on first attempt.

  5. Change (vs. baseline) in Focused Attention and Information processing speed [ Time Frame: baseline, week 14, week 16, within 72 hours of ending Ranger training ]
    Digit-Symbol Coding

  6. Change (vs. baseline) in physiological resiliency [ Time Frame: baseline, week 14, week 16, within 72 hours of ending Ranger training ]
    Composite score from Patient Reported Outcomes Measurement Information System (PROMIS), v. 1.0 for Applied Cognition, Fatigue, & Sleep-related impairment


Secondary Outcome Measures :
  1. Change (vs. baseline) in Working Memory [ Time Frame: baseline, week 14, week 16,within 72 hours of ending Ranger training ]
    Figural Continuous Paired Associates Test (FCPAT; Turner, Drummond, Salamat, & Brown 2007)

  2. Anxiety as a Measure of Psychological Functioning [ Time Frame: baseline, week 14, week 16, within 72 hours of ending Ranger training ]
    Anxiety: Spielberger State / Trait Anxiety Inventory (STAI; Speilberger 1983)

  3. Stress Response [ Time Frame: within 72 hours of ending Ranger training ]
    Peritraumatic Distress Inventory (PDI; Brunet et al. 2001)

  4. Mood State as a measure of Psychological Functioning [ Time Frame: baseline, week 14, week 16, within 72 hours of ending Ranger training ]
    Mood State:Profile of Mood States - Bipolar (POMS-Bipolar;Lohr and McNair 1988)

  5. Change (vs. baseline) in Reasoning [ Time Frame: baseline, week 14, week 16, within 72 hours of ending Ranger training ]
    Grammatical Reasoning (Lieberman, Caruso, Niro, & Bathalon 2006)

  6. Change (vs. baseline) in Visual Attention [ Time Frame: baseline, week 14, week 16, within 72 hours of ending Ranger training ]
    Four-Choice Visual Reaction Time Test (Lieberman, Caruso, Niro, & Bathalon 2006)

  7. Change (vs. baseline) in Decision-Making [ Time Frame: baseline, week 14, week 16, within 72 hours of ending Ranger training ]
    Balloon Analogue Risk Task (BART: Lejuez et al., 2002)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908932


Locations
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United States, Georgia
US Army, Fort Benning
Fort Benning, Georgia, United States, 31905
United States, Maryland
National Institutes of Health
Bethesda, Maryland, United States, 20892
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Aker Biomarine Antarctic AS
Investigators
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Principal Investigator: 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

Publications:

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02908932     History of Changes
Other Study ID Numbers: Pro00051532
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No