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

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-01

Study Completion Date

2016-08-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Suicide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Study Juice

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

Other names: none

Group Type EXPERIMENTAL

Study Juice

Intervention Type DRUG

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).

Placebo Juice

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

Other names: none

Group Type PLACEBO_COMPARATOR

Placebo Juice

Intervention Type DRUG

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.

Interventions

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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).

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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SMARTFISH® Nutrifriend 1100 Omega-3 formulated juice Other names: Smartfish (placebo juice)

Eligibility Criteria

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Inclusion Criteria

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

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

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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No