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临床试验/NCT06462898
NCT06462898招募中不适用

Evaluate the Use of Omega-3 Fortified Smoothies to Improve Omega-3 Index and Physical Performance Related Outcomes Among Soldiers

Uniformed Services University of the Health Sciences4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
4
主要终点
Omega-3 Index

研究概览

简要总结

The goal of this clinical trial is to test the effect of omega-3 on physical performance and recovery of Soldiers.

Objectives 1: Assess the impact of 8-weeks of daily consumption of 1600mg of omega-3 fortified smoothie on O3I response.

Objective 2: Determine the relationship between O3I and measures of performance and recovery.

Participants will:

  • Be randomly assigned to placebo group or to the omega-3 fortified smoothie group.
  • The intervention group will take omega-3 fortified smoothies and controls will consume a non-fortified smoothie, five days a week for 8 weeks.
  • Participate in Army Combat Fitness Tests (ACFT)
  • Complete surveys that assess dietary intake, physical activity (PAQ) and sleep quality (PSQI).
  • Complete a finger prick to determine omega-3 index.

Assessments will be collected pre/post intervention. Researchers will compare intervention and placebo groups to see if omega-3 levels increase, and improve physical performance and recovery.

详细描述

Evidence suggests that mental and physical health are positively related to the omega-3 intake, and studies indicate that supplementation of omega-3 fatty acids may improve muscle recovery and range of motion while decreasing soreness and pain.

Omega-3 fatty acids are an essential part of the diet and are found primarily in marine-based sources of fatty fish including salmon, mackerel, and herring. The Omega-3 Index (O3I) is a reliable method used to measure omega-3 status, more specifically it represents the sum of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), as a percentage of red blood cells. Currently, O3I is the preferred method for assessing omega-3 status given its low biological variability and its ability to be measured in either the fed or fasted state. Generally, the O3I increases with greater consumption of marine-based omega-3; however, the extent varies by individual. Research indicates the general population and Service members alike have a low O3I (~4%) and therefore at risk for poor health and suboptimal physical performance. For optimal health, performance and a decreased risk for cardiovascular disease an O3I of ≥ 8 % is desirable.

The research utilizing the Omega-3 Index as a measure of omega-3 fatty acids began in relation to preventing severe cardiovascular risks. The research has expanded shows that omega-3 fatty acids can reduce triglyceride levels and may serve as an effective treatment option for cardiovascular disease, osteoporosis, psoriasis, and arthritis. Omega-3 fatty acids are thought to inhibit eicosanoids and inflammatory cytokines leading to analgesic effects. Additionally, preliminary studies support a rehabilitative role of omega-3 fatty acids in maintaining muscle mass and minimizing muscle wasting during a prolonged period of limb immobilization (i.e., leg cast). Furthermore, O3I levels have been positively correlated with muscle protein synthesis and enhanced recovery from muscle damaging exercise (i.e. delayed onset muscle soreness), in both athletic and military populations.

Improving Service Members health and maintaining the ability to perform optimally are high priorities. An average O3I of ~4% is concerning. These findings, although not surprising given the lack of foods containing omega-3 fatty acids across military installations, require action. Innovative solutions to provide Service Members with omega-3 fatty acids are needed to achieve health and performance benefits. Therefore, the purpose of this study is to examine whether increasing omega-3 fatty acid intake using a novel fortified food product improves performance and recovery outcomes in Holistic Health and Fitness (H2F) soldiers.

Researchers hypothesize regular consumption (one smoothie per day, five days per week, for eight weeks) of omega-3 fortified smoothies (1600 mg omega-3 per smoothie) will increase O3I to 8% compared to a control group. Researchers also hypothesize improvements in performance markers related to strength, flexibility, aerobic capacity and power as assessed by the Army Combat Fitness Test (ACFT), rate of perceived exertion (RPE), and recovery (a visual analog scale (VAS) for pain) in the intervention group compared to control. Researchers hypothesize the control group will not reach an O3I of 8% and measures of performance and recovery will be statistically lower than in the intervention group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Participants will be blinded. The research team will pre-mix the drinks and have them labeled for participants daily. Both drinks look and taste the same.

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Active Duty Military Personnel
  • Current soldier at Ft. Drum or Ft. Campbell.
  • Able and willing to complete two Army Combat Fitness Test (ACFT) (Week 1 and week 8)
  • Willing to obtain two finger pricks for the Omega-3 Index (week 1 and week 8)

排除标准

  • Allergic to fish

结局指标

主要结局

Omega-3 Index

时间窗: Week 1 and Week 8

Omega-3 Index will be measured through finger prick, obtaining 1-2 drops of blood on a collection card to be sent to OmegaQuant for analysis. A score of 8-12% is desirable, 4-7.9% is moderate and \< 4% is low.

Army Combat Fitness Test (ACFT)

时间窗: Week 1 and Week 8

ACFT test will be performed at Week 1 baseline and Week 8 post-intervention to show changes in physical performance.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Melissa Rittenhouse

Nutritionist/Exercise Scientist

Uniformed Services University of the Health Sciences

研究点 (4)

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