Clinical trial NCT06462898: The Effect of Omega-3 Fortified Smoothies on Omega-3 Index and Physical Performance Related Outcomes Among Soldiers
Official title: Evaluate the Use of Omega-3 Fortified Smoothies to Improve Omega-3 Index and Physical Performance Related Outcomes Among Soldiers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutrition, Healthy
Keywords: Omega-3 fatty acids
Holistic Health and Fitness (H2F)
Army Combat Fitness Test (ACFT)
Performance
Nutrition
Recovery
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
Collaborators: name: Henry M. Jackson Foundation for the Advancement of Military Medicine
First posted: 2024-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A blinded randomized-placebo control trial will be conducted in collaboration with the Army Holistic Health and Fitness (H2F) Program. Participants will be randomly selected from two H2F training sites: Ft. Campbell and Ft. Drum. In total, 100 participants will be randomly selected. Each site will have participants assigned to the placebo group and omega-3 enhanced smoothie group. Participants will be excluded if they have a fish allergy or if they are unable to complete an Army Combat Fitness Test (ACFT) for any reason. Participants taking omega-3 supplements will not be excluded, but will be instructed to be consistent for the duration of the study.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

A blinded randomized-placebo control trial will be conducted in collaboration with the Army Holistic Health and Fitness (H2F) Program. Participants will be randomly selected from two H2F training sites: Ft. Campbell and Ft. Drum. In total, 100 participants will be randomly selected. Each site will have participants assigned to the placebo group and omega-3 enhanced smoothie group. Participants will be excluded if they have a fish allergy or if they are unable to complete an Army Combat Fitness Test (ACFT) for any reason. Participants taking omega-3 supplements will not be excluded, but will be instructed to be consistent for the duration of the study.

Previous research already indicates omega-3 status is low in military personal. Increasing omega-3 fatty acid intake will not only help maintain a healthy force by minimizing chronic disease risks, if researchers determine omega-3 fatty acids improve performance or recovery, guidelines can be developed and soldiers can be educated, possibly increasing the demand for these types of foods or alternatives will lead the way in improving the military nutrition environment.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Allergic to fish

Primary outcomes:
measure: Omega-3 Index
timeFrame: Week 1 and Week 8
measure: Army Combat Fitness Test (ACFT)
timeFrame: Week 1 and Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Campbell North
country: United States
facility: Fort Campbell
state: Kentucky
city: Fort Drum
country: United States
facility: Fort Drum
state: New York
Study officials:
affiliation: Uniformed Services University Health Sciences/Henry M. Jackson Foundation
name: Melissa Rittenhouse, PhD
role: PRINCIPAL_INVESTIGATOR
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