The Better Resiliency Among Veterans With Omega-3's (BRAVO) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Medical University of South Carolina
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Bernadette Marriott, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01901887
First received: July 2, 2013
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

The BRAVO study seeks to determine if dietary supplementation with omega-3 highly unsaturated fatty acids (omega-3 HUFAs) reduces the risk for serious suicidal behaviors, suicidal thinking, negative emotions, and symptoms associated with suicide risk, in a Veteran population that is at risk for suicidal behaviors. This study seeks to evaluate the efficacy of omega-3 HUFAs among a representative population of US Veterans already receiving appropriate medical care so that if successful, these results can be readily applied to broader populations.


Condition Intervention
Suicide
Drug: Study Juice
Drug: Placebo Juice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: The Better Resiliency Among Veterans With Omega-3's (BRAVO) Study: A Double Blind, Placebo-Controlled Trial of Omega-3 Fatty Acid Supplementation Among Military Veterans

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Impact of omega-3 HUFA supplementation on suicidal behaviors and thinking among Veterans. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    Examine to see if dietary supplementation with omega-3 HUFAs results in fewer episodes of a New Episode of Significant Suicide Risk (NESSR)*, reduces symptom assessment scores for suicidality, reduces implicit associations with suicide and death, and improves performance scores on suicide related cognition tests.

    * A NESSR is defined as the occurrence of any of the following: a) a suicide death, or b) a suicide attempt, or c) an inpatient admission with suicide risk, or d) a clinical diagnosis based on the BRAVO psychiatrist-administered Columbia-Suicide Severity Rating Scale and psychiatrist review of participant medical history and physical.



Secondary Outcome Measures:
  • Impact of omega-3 HUFA supplementation on symptoms of negative affect associated with suicide risk among Veterans. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Examine to see if dietary supplementation with omega-3 HUFAs reduces symptoms of perceptions of daily stress, anxiety, depression, and hopelessness.

  • Impact of omega-3 HUFA supplementation on symptoms of post-traumatic stress disorder (PTSD) associated with suicide risk among Veterans. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Examine to see if dietary supplementation with omega-3 HUFAs lowers the number of moderate to severe symptoms of PTSD, and decreases the severity of symptoms of PTSD among subjects with moderate to severe symptoms.

  • Impact of omega-3 HUFA supplementation on symptoms of cognitive functioning associated with suicide risk among Veterans. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Examine to see if dietary supplementation with omega-3 HUFAs improves sustained attention, response inhibition, and cognitive control; determine if changes in cognitive parameters are associated with changes in negative affect; and, determine if cognitive changes are associated with changes in suicide parameters.


Other Outcome Measures:
  • Impact of omega-3 HUFA supplementation among subjects with moderate to severe depressive symptoms to evaluate efficacy for clinically significant depressive symptoms. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Examine to see if higher blood levels of omega-3 HUFAs correlate with scores on the Beck Depression Inventory, and increase likelihood of a 50% reduction in depressive symptoms.

  • Impact of dietary supplementation with omega-3 fatty acids on alcohol consumption in suicidal Veterans with alcohol use disorders. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Examine to see if dietary supplementation with omega-3 HUFAs decreases alcohol use in alcohol-dependent individuals; decreases alcohol consumption in non-alcohol-dependent individuals who endorse risky alcohol use in the past 12 months; decreases obsessive and compulsive thoughts about alcohol; and, decreases use of cigarettes among persons who smoke >10 cigarettes/day. Examine to see if decreases in alcohol consumption are associated with decreases in negative affect and impulsivity; and, if they are associated with decreased suicidal ideation/behaviors.

  • Impact of an omega-3 HUFA intervention on prefrontal hypo activation to risky decision-making and recall of past suicidal events in suicide attempters, using functional Magnetic Resonance Imaging (fMRI). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Determine if dietary supplementation with omega-3 fatty acids increases activation of frontal brain regions associated with risky decision-making (e.g., orbitofrontal cortex); and those associated with suicide attempt recall (e.g., medial prefrontal cortex.)

  • Suicidal ideation and behavior at 5-months post treatment-initiation by fMRI. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Determine if increases in frontal activation to risky decision-making and recall of past suicidal events from baseline to 5-months post treatment-initiation are associated with less suicidal ideation and behavior at > 5-months post treatment-initiation.


Estimated Enrollment: 300
Study Start Date: March 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Juice

3,300 mg of Omega-3 HUFAs per day for 6 months

Other names: none

Drug: Study Juice
The intervention will be 3 boxes/day for 6 months of SMARTFISH® Nutrifriend 1100, a commercially available smoothie juice box containing 1,100 mg of omega-3 HUFAs/200 ml box (approximately 550 mg EPA and 550 mg DHA/box) for a total of 3,300 mg of omega-3 HUFAs/day (approximately 1,650 mg EPA and 1,650 mg DHA/day).
Other Names:
  • SMARTFISH® Nutrifriend 1100
  • Omega-3 formulated juice
Placebo Comparator: Placebo Juice

3,300 mg of macadamia nut oil per day for 6 months

Other names: none

Drug: Placebo Juice
The placebo will be 3 boxes/day for 6 months of a placebo juice which will be identical to the study juice except that it will substitute 1,100 mg of macadamia nut oil/200 ml juice box in place of the omega-3 HUFAs for a total of 3,300 mg of macadamia nut oil/day.
Other Name: Other names: Smartfish (placebo juice)

Detailed Description:

The BRAVO study seeks to determine if dietary supplementation with omega-3 highly unsaturated fatty acids (omega-3 HUFAs) reduces the risk for serious suicidal behaviors, suicidal thinking, negative emotions, and symptoms associated with suicide risk, in a Veteran population that is at risk for suicidal behaviors. Changes in cognitive processes specific to suicide risk will be evaluated, including implicit associations, response inhibition and sustained attention. Sub-analyses will evaluate efficacy in reducing depressive symptoms, alcohol and nicotine use among Veterans with concomitant significant depressive symptoms, and alcohol and nicotine use disorders. In addition, a sub-study will utilize functional magnetic resonance imaging (fMRI) to evaluate the neuropsychological and neurophysiological effects of the omega-3 HUFAs. This study seeks to evaluate the efficacy of omega-3 HUFAs among a representative population of US Veterans already receiving appropriate medical care so that if successful, these results can be readily applied to broader populations.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria- Primary study

  1. a US Military Services Veteran identified as part of either of the following groups:

    1. VA Veterans that have been identified as being at risk of suicide and have a current, active treatment plan at the VA
    2. If enrolling subjects from outside the VA or the subject is a non-VA veteran, the subject must presently be under the care of a mental health professional
  2. age 18 - 90
  3. within the last 3 months, either

    1. a suicide attempt, or
    2. an inpatient admission with suicide risk, or
    3. a clinical diagnosis based on the BRAVO psychiatrist-administered Columbia-Suicide Severity Rating Scale (C-SSRS) and psychiatrist review of participant medical history and physical, or
    4. a score of 0 or greater on the Implicit Associations Test-Suicide (IAT-S)
  4. participant can safely eat walnuts, pecans, almonds, peanuts and all other nuts
  5. participant can safely eat apples, pears, pomegranates, aronia, jackfruit, and passion fruit
  6. participant can safely eat the herb rosemary, and the fish salmon, trout and cod
  7. participant can safely drink and eat food that contain whey and/or milk protein
  8. willingness to drink the juice boxes 3 times each day for 6 months
  9. have a stable residence with adequate space to store the juice
  10. capacity to provide written informed consent

Additional inclusion criteria for Depressive Symptoms sub-analysis

  1. enrollment in the primary study of suicide risk reduction
  2. a Beck Depression Inventory ≥30
  3. a diagnosis of a depressive disorder

Additional inclusion criteria for Alcohol and Nicotine use sub-analysis

  1. enrollment in the primary study of suicide risk reduction
  2. diagnosis of an alcohol use disorder or "at risk drinking patterns"
  3. self-report of smoking >10 cigarettes/d.

Exclusion criteria-

  1. unstable medical conditions requiring immediate attention or medical conditions that preclude potential study participation for the duration of the study
  2. history of seizures, except for febrile seizures during childhood
  3. persons who are diagnosed with diabetes
  4. those taking Isotretinoin (Accutane )
  5. allergy, hypersensitivity, or intolerance to fish oils or omega-3 fats
  6. allergy, hypersensitivity, or intolerance to Macadamia nuts or any nuts such as almonds, walnuts, pecans, peanuts, etc.
  7. allergy, hypersensitivity, or intolerance to eat apples, pears, pomegranates, aronia, jackfruit, and passion fruit
  8. allergy, hypersensitivity, or intolerance to the herb rosemary, and the fish: salmon, trout and cod
  9. allergy, hypersensitivity, or intolerance to whey and/or milk protein
  10. life threatening medical conditions or life expectancy of less than 6 months.
  11. pregnancy or lactation or intention to become pregnant within the next 12 months
  12. acute intoxication or withdrawal from alcohol or other substances (to be determined by a clinical team member)
  13. a cognitive impairment severe enough to preclude informed consent or valid responses on self-report questionnaires
  14. Body Mass Index (BMI) <18.5
  15. evidence of disordered eating or risk of malnutrition based on the Eating Attitudes Test (EAT-26)
  16. relapsing of remitting Multiple Sclerosis
  17. unstable or rapidly progressive neurological disease
  18. history of significant behavioral instability
  19. participating in another research study
  20. individuals that take anticoagulants regularly including; high dose aspirin; warfarin or Coumadin

Additional exclusion criteria for fMRI Study Only (40 individuals):

  • inability or unwillingness to participate in an fMRI scan,
  • presence of metallic objects in the body that would interfere with the scan
  • pronounced claustrophobia
  • body weight >300 pounds
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901887

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Bravo Study Line    888-322-6884    BRAVO@musc.edu   
Principal Investigator: Bernadette Marriott, PhD         
Sponsors and Collaborators
Medical University of South Carolina
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Bernadette Marriott, PhD Medical University of South Carolina
  More Information

Publications:
Responsible Party: Bernadette Marriott, Professor Department of Medicine, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01901887     History of Changes
Other Study ID Numbers: BRAVO2013
Study First Received: July 2, 2013
Last Updated: April 23, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board
United States: Federal Government

Keywords provided by Medical University of South Carolina:
Veterans
Suicidality

ClinicalTrials.gov processed this record on October 19, 2014