Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462898
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-06
Brief Title:
The Effect of Omega-3 Fortified Smoothies on Omega-3 Index and Physical Performance Related Outcomes Among Soldiers
Sponsor:
Uniformed Services University of the Health Sciences
Organization:
Uniformed Services University of the Health Sciences
Study Overview
Official Title:
Evaluate the Use of Omega-3 Fortified Smoothies to Improve Omega-3 Index and Physical Performance Related Outcomes Among Soldiers
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
H2FO3
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 prepost 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 prepost 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 ie leg cast Furthermore O3I levels have been positively correlated with muscle protein synthesis and enhanced recovery from muscle damaging exercise ie 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 ie leg cast Furthermore O3I levels have been positively correlated with muscle protein synthesis and enhanced recovery from muscle damaging exercise ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None