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

Medical University of South Carolina (MUSC)

Status and phase: Terminated; Phase 1

Conditions: Suicide

Treatments: Drug: Placebo Juice; Drug: Study Juice

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01901887

BRAVO2013

Details and patient eligibility

About

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 and non-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 and non-Veterans already receiving appropriate medical care so that if successful, these results can be readily applied to broader populations in the US.

Full 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 and non-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 and non-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 and non-Veterans already receiving appropriate medical care so that if successful, these results can be readily applied to broader populations in the US.

Enrollment: 125 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria- Primary study

1. a Veteran or non-Veteran identified as being at risk for suicide and presently under the care of a mental healthcare provider (A release of information from his/her mental healthcare provider is required.)

2. age 18 - 90

3. within the participant's medical history, either

   1. a suicide attempt in the last 6 months, or
   2. a suicide attempt during the adult lifetime AND current diagnosis of an episode of depression as diagnosed on the Mini International Neuropsychiatric Interview (MINI), or
   3. an inpatient admission with suicide risk in the last 6 months, or
   4. an inpatient admission with suicide risk during the adult lifetime AND current diagnosis of an episode of depression as diagnosed on the Mini International Neuropsychiatric Interview (MINI), or
   5. positive suicidal behavior or ideation based on a psychiatrist- administered Columbia-Suicide Severity Rating Scale (C-SSRS) and psychiatrist review of participant medical history and physical], or
   6. a score of 0 or greater on the Implicit Associations Test-Suicide (IAT-S), or
   7. > or = 9 on the Beck Hopelessness Scale (BHS) and psychiatrist review of participant medical history and physical

4. participant can safely eat walnuts, pecans, almonds, peanuts and all other nuts

5. participant can safely eat apples, peaches, 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
   • history of a single seizure episode as an adult if not being maintained on anti-seizure medication; this single seizure must not be related to a primary seizure disorder (must not be epilepsy)

3. persons who have received a diagnosis of 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 apples, peaches, 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 or >45

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. regular use of anticoagulants such as high dose aspirin, warfarin or Coumadin

21. take hypoglycemic agents

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 2 patient groups, including a placebo group

Study Juice

Experimental group

Description:

3,300 mg of Omega-3 HUFAs per day for 6 months Other names: none

Treatment:

Drug: Study Juice

Placebo Juice

Placebo Comparator group

Description:

3,300 mg of macadamia nut oil per day for 6 months Other names: none

Treatment:

Drug: Placebo Juice