The Effect of Omega-3 Fortified Smoothies on Omega-3 Index and Physical Performance Related Outcomes Among Soldiers
NCT ID: NCT06462898
Last Updated: 2024-06-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-02-01
Study Completion Date
2024-09-30
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Nutrition, Healthy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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 Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Participants
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.
Study Groups
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Omega-3 Fortified Protein Smoothie
Participants will receive a shaker bottle containing 1 tbsp omega-3 powder and 1 scoop protein powder mixed with water, after morning physical training, five days a week, for eight weeks.
Group Type
ACTIVE_COMPARATOR
Omega-3 Fortified Protein Smoothie
Intervention Type
DIETARY_SUPPLEMENT
Omega-3 powder and protein supplementation.
Non-Fortified Protein Smoothie
Participants will receive a shaker bottle containing 1 scoop protein mixed with water, after morning physical training, five days a week, for eight weeks.
Group Type
PLACEBO_COMPARATOR
Non-Fortified Protein Smoothie
Intervention Type
DIETARY_SUPPLEMENT
Protein without omega-3 powder supplementation.
Interventions
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Omega-3 Fortified Protein Smoothie
Omega-3 powder and protein supplementation.
Intervention Type
DIETARY_SUPPLEMENT
Non-Fortified Protein Smoothie
Protein without omega-3 powder supplementation.
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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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)
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
64 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Henry M. Jackson Foundation for the Advancement of Military Medicine
OTHER
Sponsor Role
collaborator
Uniformed Services University of the Health Sciences
FED
Sponsor Role
lead
Responsible Party
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Melissa Rittenhouse
Nutritionist/Exercise Scientist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Melissa Rittenhouse, PhD
Role: PRINCIPAL_INVESTIGATOR
Uniformed Services University Health Sciences/Henry M. Jackson Foundation
Locations
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Fort Campbell
Fort Campbell North, Kentucky, United States
Site Status
ACTIVE_NOT_RECRUITING
Fort Drum
Fort Drum, New York, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Brandon Lee
Role: primary
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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USUHS.2023-118
Identifier Type: -
Identifier Source: org_study_id
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