Ranger Resilience and Improved Performance on Phospholipid Bound Omega-3's
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 555
- 试验地点
- 6
- 主要终点
- Change (vs. baseline) in psychological resiliency
研究概览
简要总结
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).
详细描述
The U.S. Army invests significant time and money in training its leaders. Individuals who choose the Army Infantry as their career expend significant time, energy, and commitment to self-development to achieve their career goals. While Infantry Basic Officer Leaders Course (IBOLC) graduates have demonstrated their ability to perform skills required for Ranger School success, personal stress during Ranger School appears to be a continual barrier to successful Ranger School graduation, with only 45.25% of IBOLC graduates having passed Ranger training in 2013. Omega-3 highly unsaturated fatty acids (HUFAs), specifically EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), are concentrated in neural tissues, are essential for neural function (McNamara & Carlson, 2006 ), and must be obtained from dietary sources. United States (U.S.) food production practices over the last century have resulted in a dramatic change in the fatty acid profile of the U.S. diet. At the same time, evidence continues to build regarding the potential importance of omega-3 HUFAs on emotional state, cognitive function, and mental health. The purpose of this study is to investigate whether supplementation with omega-3 HUFAs from a krill oil concentrate will improve emotional status and related cognitive performance under stress among Infantry Officer Trainees during IBOLC, (Part I) and subsequent Ranger School (Part II). More broadly, Americans continue to report living under a high level of stress, with 20% reporting states of severe stress. The potential impact of this study would be information that would support the role for dietary supplementation of omega-3 HUFAs from krill oil concentrate in contributing to improving mood, emotional status, and cognitive performance among the U.S. population.
Overview: The Ranger Resilience and Improved Performance on Phospholipid Bound Omega-3's (RRIPP-3 Study) is a double-blinded, randomized, placebo-controlled trial conducted by the Medical University of South Carolina (MUSC) in partnership with the National Institutes of Health (NIH) working with the permission of the leadership of IBOLC and the U.S. Army Ranger Training School at Fort Benning, GA. Participants (450 individuals) will be randomized to one of two experimental groups for 2 Parts: Part I: IBOLC and Part II Ranger School.
Intervention Schedule: Participants will be provided with capsules of krill oil concentrate (2.3g/day HUFAs with EPA and DHA ratio of approximately 2:1) or placebo (macadamia nut oil and appropriate matching colorant for krill oil) delivered in 8 capsules per day during Part I (IBOLC training) only.
Compliance Monitoring: Finger prick blood samples will be collected for assessment of fatty acids at baseline and at specific time points during IBOLC and pre- and post-Ranger training and analyzed at a collaborating laboratory at the National Institutes of Health.
Study Participants: Sample Size: The sample size calculation is based on differences in one of the specific cognitive tests between the placebo and treatment groups based on prior omega-3 supplementation studies. The total sample size needed to detect the between groups difference is 352 (176 per group). Accounting for a potential attrition rate of 25%, the total number of enrolled subjects=450. Calculations were made using PASS 2008 software, (Version 08.0.13, Kaysvile, Utah).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Entry into IBOLC
- •No self-reported previous injuries that would impede potential physical performance success in IBOLC or Ranger training
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Phospholipid-bound omega-3 supplement (Dietary Supplement)
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).
干预措施: Placebo supplement (Dietary Supplement)
结局指标
主要结局
Change (vs. baseline) in psychological resiliency
时间窗: baseline, week 14, week 16, within 72 hours of ending Ranger training
Connor-Davidson Resilience Scale (CD-RISC)
Group differences on Land Navigation scores (from IBOLC gradebook)
时间窗: 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.
Group differences on Marksmanship scores (from IBOLC gradebook)
时间窗: 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.
Change (vs. baseline) in Focused Attention and Information processing speed
时间窗: baseline, week 14, week 16, within 72 hours of ending Ranger training
Digit-Symbol Coding
Change (vs. baseline) in Inhibition and Rule-Making
时间窗: baseline, week 14, week 16, within 72 hours of ending Ranger training
Stroop
Change (vs. baseline) in physiological resiliency
时间窗: 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
次要结局
- 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)
- Change (vs. baseline) in Visual Attention(baseline, week 14, week 16, within 72 hours of ending Ranger training)
- Change (vs. baseline) in Decision-Making(baseline, week 14, week 16, within 72 hours of ending Ranger training)