Overview

This trial is active, not recruiting.

Condition suicide
Treatments study juice, placebo juice
Sponsor Medical University of South Carolina
Collaborator U.S. Army Medical Research and Materiel Command
Start date March 2014
End date August 2016
Trial size 300 participants
Trial identifier NCT01901887, BRAVO2013

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Experimental)
3,300 mg of Omega-3 HUFAs per day for 6 months Other names: none
study juice SMARTFISH® Nutrifriend 1100
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 Comparator)
3,300 mg of macadamia nut oil per day for 6 months Other names: none
placebo juice Other names: Smartfish (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.

Primary Outcomes

Measure
Impact of omega-3 HUFA supplementation on suicidal behaviors and thinking among adults.
time frame: 6 months

Secondary Outcomes

Measure
Impact of omega-3 HUFA supplementation on symptoms of negative affect associated with suicide risk among adults.
time frame: 6 months
Impact of omega-3 HUFA supplementation on symptoms of post-traumatic stress disorder (PTSD) associated with suicide risk among adults.
time frame: 6 months
Impact of omega-3 HUFA supplementation on symptoms of cognitive functioning associated with suicide risk among adults.
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

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
Principal investigator Bernadette Marriott, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Medical University of South Carolina.