Nutrition, HealthyH2FO3NCT06462898
The Effect of Omega-3 Fortified Smoothies on Omega-3 Index and Physical Performance Related Outcomes Among Soldiers
A study testing Omega-3 Fortified Protein Smoothie and Non-Fortified Protein Smoothie in people with Nutrition, Healthy, run by Uniformed Services University of the Health Sciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Omega-3 Fortified Protein Smoothie and Non-Fortified Protein Smoothie
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Allergic to fish
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Active, not recruiting
Fort Campbell
Fort Campbell North, Kentucky, 42223
- Recruiting
Fort Drum
Fort Drum, New York, 13602
Brandon Lee
About this study
Official title: Evaluate the Use of Omega-3 Fortified Smoothies to Improve Omega-3 Index and Physical Performance Related Outcomes Among Soldiers
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.
Read more
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.
Read the 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.
- Conditions
- Nutrition, Healthy
- Being tested
- Omega-3 Fortified Protein Smoothie, Non-Fortified Protein Smoothie
- Keywords
- Omega-3 fatty acids, Holistic Health and Fitness (H2F), Army Combat Fitness Test (ACFT), Performance, Nutrition, Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fortified Protein SmoothieDietary supplement
Omega-3 powder and protein supplementation.
Non-Fortified Protein SmoothieDietary supplement
Protein without omega-3 powder supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Fortified Protein Smoothie | Active comparator | 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. Receives: Dietary Supplement: Omega-3 Fortified Protein Smoothie |
| Non-Fortified Protein Smoothie | Placebo comparator | Participants will receive a shaker bottle containing 1 scoop protein mixed with water, after morning physical training, five days a week, for eight weeks. Receives: Dietary Supplement: Non-Fortified Protein Smoothie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omega-3 Index
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.
Measured: Week 1 and Week 8
Army Combat Fitness Test (ACFT)
ACFT test will be performed at Week 1 baseline and Week 8 post-intervention to show changes in physical performance.
Measured: Week 1 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Feb 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Principal investigator, Melissa Rittenhouse, Uniformed Services University of the Health Sciences
- Investigators
- Melissa Rittenhouse, PhD, Principal investigator, Uniformed Services University Health Sciences/Henry M. Jackson Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462898
- Sponsor's protocol ID
- USUHS.2023-118
- Acronym
- H2FO3
- Status last verified
- Jun 2024
- First submitted
- 6 May 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Practice guideline for the treatment of patients with major depressive disorder (revision). American Psychiatric Association. Am J Psychiatry. 2000 Apr;157(4 Suppl):1-45. No abstract available.
PubMed 10767867Bozzatello P, De Rosa ML, Rocca P, Bellino S. Effects of Omega 3 Fatty Acids on Main Dimensions of Psychopathology. Int J Mol Sci. 2020 Aug 21;21(17):6042. doi: 10.3390/ijms21176042.
PubMed 32839416Colangelo LA, He K, Whooley MA, Daviglus ML, Liu K. Higher dietary intake of long-chain omega-3 polyunsaturated fatty acids is inversely associated with depressive symptoms in women. Nutrition. 2009 Oct;25(10):1011-9. doi: 10.1016/j.nut.2008.12.008. Epub 2009 Feb 4.
PubMed 19195841Guskiewicz KM, Marshall SW, Bailes J, McCrea M, Harding HP Jr, Matthews A, Mihalik JR, Cantu RC. Recurrent concussion and risk of depression in retired professional football players. Med Sci Sports Exerc. 2007 Jun;39(6):903-9. doi: 10.1249/mss.0b013e3180383da5.
PubMed 17545878Hibbeln JR. Fish consumption and major depression. Lancet. 1998 Apr 18;351(9110):1213. doi: 10.1016/S0140-6736(05)79168-6. No abstract available.
PubMed 9643729Hibbeln JR, Gow RV. The potential for military diets to reduce depression, suicide, and impulsive aggression: a review of current evidence for omega-3 and omega-6 fatty acids. Mil Med. 2014 Nov;179(11 Suppl):117-28. doi: 10.7205/MILMED-D-14-00153.
PubMed 25373095Johnston DT, Deuster PA, Harris WS, Macrae H, Dretsch MN. Red blood cell omega-3 fatty acid levels and neurocognitive performance in deployed U.S. Servicemembers. Nutr Neurosci. 2013 Jan;16(1):30-8. doi: 10.1179/1476830512Y.0000000025. Epub 2012 Jun 28.
PubMed 22748167Maes M, Smith R, Christophe A, Cosyns P, Desnyder R, Meltzer H. Fatty acid composition in major depression: decreased omega 3 fractions in cholesteryl esters and increased C20: 4 omega 6/C20:5 omega 3 ratio in cholesteryl esters and phospholipids. J Affect Disord. 1996 Apr 26;38(1):35-46. doi: 10.1016/0165-0327(95)00092-5.
PubMed 8735157Su KP, Matsuoka Y, Pae CU. Omega-3 Polyunsaturated Fatty Acids in Prevention of Mood and Anxiety Disorders. Clin Psychopharmacol Neurosci. 2015 Aug 31;13(2):129-37. doi: 10.9758/cpn.2015.13.2.129.
PubMed 26243838Teo L, Crawford C, Yehuda R, Jaghab D, Bingham JJ, Chittum HK, Gallon MD, O'Connell ML, Arzola SM, Berry K. Omega-3 polyunsaturated fatty acids to optimize cognitive function for military mission-readiness: a systematic review and recommendations for the field. Nutr Rev. 2017 Jun 1;75(suppl_2):36-48. doi: 10.1093/nutrit/nux008.
PubMed 28969342Weissman MM, Bland RC, Canino GJ, Faravelli C, Greenwald S, Hwu HG, Joyce PR, Karam EG, Lee CK, Lellouch J, Lepine JP, Newman SC, Rubio-Stipec M, Wells JE, Wickramaratne PJ, Wittchen H, Yeh EK. Cross-national epidemiology of major depression and bipolar disorder. JAMA. 1996 Jul 24-31;276(4):293-9.
PubMed 8656541Bucher HC, Hengstler P, Schindler C, Meier G. N-3 polyunsaturated fatty acids in coronary heart disease: a meta-analysis of randomized controlled trials. Am J Med. 2002 Mar;112(4):298-304. doi: 10.1016/s0002-9343(01)01114-7.
PubMed 11893369Patel A, Rova U, Christakopoulos P, Matsakas L. Assessment of Fatty Acids Profile and Omega-3 Polyunsaturated Fatty Acid Production by the Oleaginous Marine Thraustochytrid Aurantiochytrium sp. T66 Cultivated on Volatile Fatty Acids. Biomolecules. 2020 Apr 29;10(5):694. doi: 10.3390/biom10050694.
PubMed 32365742Gonzalez DE, McAllister MJ, Waldman HS, Ferrando AA, Joyce J, Barringer ND, Dawes JJ, Kieffer AJ, Harvey T, Kerksick CM, Stout JR, Ziegenfuss TN, Zapp A, Tartar JL, Heileson JL, VanDusseldorp TA, Kalman DS, Campbell BI, Antonio J, Kreider RB. International society of sports nutrition position stand: tactical athlete nutrition. J Int Soc Sports Nutr. 2022 Jun 23;19(1):267-315. doi: 10.1080/15502783.2022.2086017. eCollection 2022.
PubMed 35813846Kris-Etherton PM, Richter CK, Bowen KJ, Skulas-Ray AC, Jackson KH, Petersen KS, Harris WS. Recent Clinical Trials Shed New Light on the Cardiovascular Benefits of Omega-3 Fatty Acids. Methodist Debakey Cardiovasc J. 2019 Jul-Sep;15(3):171-178. doi: 10.14797/mdcj-15-3-171.
PubMed 31687095
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Use of Omega-3 Fortified Smoothies to Improve Omega-3 Index and Physical Performance Related Outcomes Among Soldiers
- ClinicalTrials.gov ID
- NCT06462898
- Acronym / sponsor ID
- H2FO3 / USUHS.2023-118
- Conditions
- Nutrition, Healthy
- Keywords
- Omega-3 fatty acids, Holistic Health and Fitness (H2F), Army Combat Fitness Test (ACFT), Performance, Nutrition, Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Fortified Protein Smoothie | Active comparator | Dietary Supplement: Omega-3 Fortified Protein SmoothieParticipants 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. |
| Non-Fortified Protein Smoothie | Placebo comparator | Dietary Supplement: Non-Fortified Protein SmoothieParticipants will receive a shaker bottle containing 1 scoop protein mixed with water, after morning physical training, five days a week, for eight weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Allergic to fish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fortified Protein SmoothieOmega-3 powder and protein supplementation. | Dietary supplement | Omega-3 Fortified Protein Smoothie |
| Non-Fortified Protein SmoothieProtein without omega-3 powder supplementation. | Dietary supplement | Non-Fortified Protein Smoothie |
Primary outcome
Omega-3 Index
Time frame: 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)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Background: PubMed 10767867Practice guideline for the treatment of patients with major depressive disorder (revision). American Psychiatric Association. Am J Psychiatry. 2000 Apr;157(4 Suppl):1-45. No abstract available.
- Background: PubMed 32839416Bozzatello P, De Rosa ML, Rocca P, Bellino S. Effects of Omega 3 Fatty Acids on Main Dimensions of Psychopathology. Int J Mol Sci. 2020 Aug 21;21(17):6042. doi: 10.3390/ijms21176042.
- Background: PubMed 19195841Colangelo LA, He K, Whooley MA, Daviglus ML, Liu K. Higher dietary intake of long-chain omega-3 polyunsaturated fatty acids is inversely associated with depressive symptoms in women. Nutrition. 2009 Oct;25(10):1011-9. doi: 10.1016/j.nut.2008.12.008. Epub 2009 Feb 4.
- Background: PubMed 17545878Guskiewicz KM, Marshall SW, Bailes J, McCrea M, Harding HP Jr, Matthews A, Mihalik JR, Cantu RC. Recurrent concussion and risk of depression in retired professional football players. Med Sci Sports Exerc. 2007 Jun;39(6):903-9. doi: 10.1249/mss.0b013e3180383da5.
- Background: PubMed 9643729Hibbeln JR. Fish consumption and major depression. Lancet. 1998 Apr 18;351(9110):1213. doi: 10.1016/S0140-6736(05)79168-6. No abstract available.
- Background: PubMed 25373095Hibbeln JR, Gow RV. The potential for military diets to reduce depression, suicide, and impulsive aggression: a review of current evidence for omega-3 and omega-6 fatty acids. Mil Med. 2014 Nov;179(11 Suppl):117-28. doi: 10.7205/MILMED-D-14-00153.
- Background: PubMed 22748167Johnston DT, Deuster PA, Harris WS, Macrae H, Dretsch MN. Red blood cell omega-3 fatty acid levels and neurocognitive performance in deployed U.S. Servicemembers. Nutr Neurosci. 2013 Jan;16(1):30-8. doi: 10.1179/1476830512Y.0000000025. Epub 2012 Jun 28.
- Background: PubMed 8735157Maes M, Smith R, Christophe A, Cosyns P, Desnyder R, Meltzer H. Fatty acid composition in major depression: decreased omega 3 fractions in cholesteryl esters and increased C20: 4 omega 6/C20:5 omega 3 ratio in cholesteryl esters and phospholipids. J Affect Disord. 1996 Apr 26;38(1):35-46. doi: 10.1016/0165-0327(95)00092-5.
- Background: PubMed 26243838Su KP, Matsuoka Y, Pae CU. Omega-3 Polyunsaturated Fatty Acids in Prevention of Mood and Anxiety Disorders. Clin Psychopharmacol Neurosci. 2015 Aug 31;13(2):129-37. doi: 10.9758/cpn.2015.13.2.129.
- Background: PubMed 28969342Teo L, Crawford C, Yehuda R, Jaghab D, Bingham JJ, Chittum HK, Gallon MD, O'Connell ML, Arzola SM, Berry K. Omega-3 polyunsaturated fatty acids to optimize cognitive function for military mission-readiness: a systematic review and recommendations for the field. Nutr Rev. 2017 Jun 1;75(suppl_2):36-48. doi: 10.1093/nutrit/nux008.
- Background: PubMed 8656541Weissman MM, Bland RC, Canino GJ, Faravelli C, Greenwald S, Hwu HG, Joyce PR, Karam EG, Lee CK, Lellouch J, Lepine JP, Newman SC, Rubio-Stipec M, Wells JE, Wickramaratne PJ, Wittchen H, Yeh EK. Cross-national epidemiology of major depression and bipolar disorder. JAMA. 1996 Jul 24-31;276(4):293-9.
- Background: PubMed 11893369Bucher HC, Hengstler P, Schindler C, Meier G. N-3 polyunsaturated fatty acids in coronary heart disease: a meta-analysis of randomized controlled trials. Am J Med. 2002 Mar;112(4):298-304. doi: 10.1016/s0002-9343(01)01114-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Rittenhouse, PhD principal investigator
Uniformed Services University Health Sciences/Henry M. Jackson Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fortified Protein Smoothie and Non-Fortified Protein Smoothie in people with Nutrition, Healthy, run by Uniformed Services University of the Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa Rittenhouse, PhD (301-295-2621, melissa.rittenhouse.ctr@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Omega-3 Index (time frame: Week 1 and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06462898, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.