Cognition Clinical Trial
— RRIPP-3Official title:
Ranger Resilience and Improved Performance on Phospholipid Bound Omega-3's
NCT number | NCT02908932 |
Other study ID # | Pro00051532 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | June 2018 |
Verified date | June 2018 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 555 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health | Bethesda | Maryland |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | US Army, Fort Benning | Fort Benning | Georgia |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | Aker Biomarine Antarctic AS |
United States,
Antypa N, Smelt AH, Strengholt A, Van der Does AJ. Effects of omega-3 fatty acid supplementation on mood and emotional information processing in recovered depressed individuals. J Psychopharmacol. 2012 May;26(5):738-43. doi: 10.1177/0269881111424928. Epub 2011 Oct 16. — View Citation
Antypa N, Van der Does AJ, Smelt AH, Rogers RD. Omega-3 fatty acids (fish-oil) and depression-related cognition in healthy volunteers. J Psychopharmacol. 2009 Sep;23(7):831-40. doi: 10.1177/0269881108092120. Epub 2008 Jun 26. — View Citation
Appleton KM, Rogers PJ, Ness AR. Updated systematic review and meta-analysis of the effects of n-3 long-chain polyunsaturated fatty acids on depressed mood. Am J Clin Nutr. 2010 Mar;91(3):757-70. doi: 10.3945/ajcn.2009.28313. Epub 2010 Feb 3. Review. — View Citation
Blasbalg TL, Hibbeln JR, Ramsden CE, Majchrzak SF, Rawlings RR. Changes in consumption of omega-3 and omega-6 fatty acids in the United States during the 20th century. Am J Clin Nutr. 2011 May;93(5):950-62. doi: 10.3945/ajcn.110.006643. Epub 2011 Mar 2. — View Citation
Bloch MH, Qawasmi A. Omega-3 fatty acid supplementation for the treatment of children with attention-deficit/hyperactivity disorder symptomatology: systematic review and meta-analysis. J Am Acad Child Adolesc Psychiatry. 2011 Oct;50(10):991-1000. doi: 10.1016/j.jaac.2011.06.008. Epub 2011 Aug 12. Review. — View Citation
Conklin SM, Harris JI, Manuck SB, Yao JK, Hibbeln JR, Muldoon MF. Serum omega-3 fatty acids are associated with variation in mood, personality and behavior in hypercholesterolemic community volunteers. Psychiatry Res. 2007 Jul 30;152(1):1-10. Epub 2007 Mar 23. — View Citation
Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. — View Citation
de la Presa Owens S, Innis SM. Docosahexaenoic and arachidonic acid prevent a decrease in dopaminergic and serotoninergic neurotransmitters in frontal cortex caused by a linoleic and alpha-linolenic acid deficient diet in formula-fed piglets. J Nutr. 1999 Nov;129(11):2088-93. — View Citation
Dretsch MN, Johnston D, Bradley RS, MacRae H, Deuster PA, Harris WS. Effects of omega-3 fatty acid supplementation on neurocognitive functioning and mood in deployed U.S. soldiers: a pilot study. Mil Med. 2014 Apr;179(4):396-403. doi: 10.7205/MILMED-D-13-00395. — View Citation
Fontani G, Corradeschi F, Felici A, Alfatti F, Migliorini S, Lodi L. Cognitive and physiological effects of Omega-3 polyunsaturated fatty acid supplementation in healthy subjects. Eur J Clin Invest. 2005 Nov;35(11):691-9. — View Citation
Freund-Levi Y, Eriksdotter-Jönhagen M, Cederholm T, Basun H, Faxén-Irving G, Garlind A, Vedin I, Vessby B, Wahlund LO, Palmblad J. Omega-3 fatty acid treatment in 174 patients with mild to moderate Alzheimer disease: OmegAD study: a randomized double-blind trial. Arch Neurol. 2006 Oct;63(10):1402-8. — View Citation
Hallahan B, Hibbeln JR, Davis JM, Garland MR. Omega-3 fatty acid supplementation in patients with recurrent self-harm. Single-centre double-blind randomised controlled trial. Br J Psychiatry. 2007 Feb;190:118-22. — View Citation
Hibbeln JR, Gow RV. The potential for military diets to reduce depression, suicide, and impulsive aggression: a review of current evidence for omega-3 and omega-6 fatty acids. Mil Med. 2014 Nov;179(11 Suppl):117-28. doi: 10.7205/MILMED-D-14-00153. Review. — View Citation
Hibbeln JR, Linnoila M, Umhau JC, Rawlings R, George DT, Salem N Jr. Essential fatty acids predict metabolites of serotonin and dopamine in cerebrospinal fluid among healthy control subjects, and early- and late-onset alcoholics. Biol Psychiatry. 1998 Aug 15;44(4):235-42. — View Citation
Hibbeln JR. Fish consumption and major depression. Lancet. 1998 Apr 18;351(9110):1213. — View Citation
Hibbeln JR. Seafood consumption, the DHA content of mothers' milk and prevalence rates of postpartum depression: a cross-national, ecological analysis. J Affect Disord. 2002 May;69(1-3):15-29. — View Citation
Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Glaser R. Omega-3 supplementation lowers inflammation and anxiety in medical students: a randomized controlled trial. Brain Behav Immun. 2011 Nov;25(8):1725-34. doi: 10.1016/j.bbi.2011.07.229. Epub 2011 Jul 19. — View Citation
Kim HY, Spector AA, Xiong ZM. A synaptogenic amide N-docosahexaenoylethanolamide promotes hippocampal development. Prostaglandins Other Lipid Mediat. 2011 Nov;96(1-4):114-20. doi: 10.1016/j.prostaglandins.2011.07.002. Epub 2011 Jul 23. Review. — View Citation
Kotani S, Sakaguchi E, Warashina S, Matsukawa N, Ishikura Y, Kiso Y, Sakakibara M, Yoshimoto T, Guo J, Yamashima T. Dietary supplementation of arachidonic and docosahexaenoic acids improves cognitive dysfunction. Neurosci Res. 2006 Oct;56(2):159-64. Epub 2006 Aug 14. — View Citation
Kris-Etherton PM, Harris WS, Appel LJ; AHA Nutrition Committee. American Heart Association. Omega-3 fatty acids and cardiovascular disease: new recommendations from the American Heart Association. Arterioscler Thromb Vasc Biol. 2003 Feb 1;23(2):151-2. Review. — View Citation
Lavie CJ, Milani RV, Mehra MR, Ventura HO. Omega-3 polyunsaturated fatty acids and cardiovascular diseases. J Am Coll Cardiol. 2009 Aug 11;54(7):585-94. doi: 10.1016/j.jacc.2009.02.084. Review. — View Citation
Lieberman HR, Tharion WJ, Shukitt-Hale B, Speckman KL, Tulley R. Effects of caffeine, sleep loss, and stress on cognitive performance and mood during U.S. Navy SEAL training. Sea-Air-Land. Psychopharmacology (Berl). 2002 Nov;164(3):250-61. Epub 2002 Sep 5. — View Citation
Lin YH, Hanson JA, Strandjord SE, Salem NM, Dretsch MN, Haub MD, Hibbeln JR. Fast transmethylation of total lipids in dried blood by microwave irradiation and its application to a population study. Lipids. 2014 Aug;49(8):839-51. doi: 10.1007/s11745-014-3918-3. Epub 2014 Jul 2. — View Citation
Martins JG. EPA but not DHA appears to be responsible for the efficacy of omega-3 long chain polyunsaturated fatty acid supplementation in depression: evidence from a meta-analysis of randomized controlled trials. J Am Coll Nutr. 2009 Oct;28(5):525-42. Review. — View Citation
McNamara RK, Able J, Jandacek R, Rider T, Tso P, Eliassen JC, Alfieri D, Weber W, Jarvis K, DelBello MP, Strakowski SM, Adler CM. Docosahexaenoic acid supplementation increases prefrontal cortex activation during sustained attention in healthy boys: a placebo-controlled, dose-ranging, functional magnetic resonance imaging study. Am J Clin Nutr. 2010 Apr;91(4):1060-7. doi: 10.3945/ajcn.2009.28549. Epub 2010 Feb 3. — View Citation
McNamara RK, Carlson SE. Role of omega-3 fatty acids in brain development and function: potential implications for the pathogenesis and prevention of psychopathology. Prostaglandins Leukot Essent Fatty Acids. 2006 Oct-Nov;75(4-5):329-49. Epub 2006 Sep 1. Review. — View Citation
Raskin R, Terry H. A principal-components analysis of the Narcissistic Personality Inventory and further evidence of its construct validity. J Pers Soc Psychol. 1988 May;54(5):890-902. — View Citation
Robinson JG, Ijioma N, Harris W. Omega-3 fatty acids and cognitive function in women. Womens Health (Lond). 2010 Jan;6(1):119-34. doi: 10.2217/whe.09.75. Review. — View Citation
Rogers PJ, Appleton KM, Kessler D, Peters TJ, Gunnell D, Hayward RC, Heatherley SV, Christian LM, McNaughton SA, Ness AR. No effect of n-3 long-chain polyunsaturated fatty acid (EPA and DHA) supplementation on depressed mood and cognitive function: a randomised controlled trial. Br J Nutr. 2008 Feb;99(2):421-31. Epub 2007 Oct 24. — View Citation
Salem N Jr, Litman B, Kim HY, Gawrisch K. Mechanisms of action of docosahexaenoic acid in the nervous system. Lipids. 2001 Sep;36(9):945-59. Review. — View Citation
Sublette ME, Hibbeln JR, Galfalvy H, Oquendo MA, Mann JJ. Omega-3 polyunsaturated essential fatty acid status as a predictor of future suicide risk. Am J Psychiatry. 2006 Jun;163(6):1100-2. — View Citation
Sublette ME, Milak MS, Hibbeln JR, Freed PJ, Oquendo MA, Malone KM, Parsey RV, Mann JJ. Plasma polyunsaturated fatty acids and regional cerebral glucose metabolism in major depression. Prostaglandins Leukot Essent Fatty Acids. 2009 Jan;80(1):57-64. doi: 10.1016/j.plefa.2008.11.004. Epub 2009 Jan 6. — View Citation
* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change (vs. baseline) in Inhibition and Rule-Making | Stroop | baseline, week 14, week 16, within 72 hours of ending Ranger training | |
Primary | Change (vs. baseline) in psychological resiliency | Connor-Davidson Resilience Scale (CD-RISC) | baseline, week 14, week 16, within 72 hours of ending Ranger training | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Change (vs. baseline) in Working Memory | Figural Continuous Paired Associates Test (FCPAT; Turner, Drummond, Salamat, & Brown 2007) | baseline, week 14, week 16,within 72 hours of ending Ranger training | |
Secondary | Anxiety as a Measure of Psychological Functioning | Anxiety: Spielberger State / Trait Anxiety Inventory (STAI; Speilberger 1983) | baseline, week 14, week 16, within 72 hours of ending Ranger training | |
Secondary | Stress Response | Peritraumatic Distress Inventory (PDI; Brunet et al. 2001) | within 72 hours of ending Ranger training | |
Secondary | Mood State as a measure of Psychological Functioning | Mood State:Profile of Mood States - Bipolar (POMS-Bipolar;Lohr and McNair 1988) | baseline, week 14, week 16, within 72 hours of ending Ranger training | |
Secondary | Change (vs. baseline) in Reasoning | Grammatical Reasoning (Lieberman, Caruso, Niro, & Bathalon 2006) | baseline, week 14, week 16, within 72 hours of ending Ranger training | |
Secondary | Change (vs. baseline) in Visual Attention | Four-Choice Visual Reaction Time Test (Lieberman, Caruso, Niro, & Bathalon 2006) | baseline, week 14, week 16, within 72 hours of ending Ranger training | |
Secondary | Change (vs. baseline) in Decision-Making | Balloon Analogue Risk Task (BART: Lejuez et al., 2002) | baseline, week 14, week 16, within 72 hours of ending Ranger training |
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