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

NCT01901887 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2018-06-12

No results posted yet for this study

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.

Conditions

  • Suicide

Interventions

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).

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.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Bernadette Marriott, PhD · Medical University of South Carolina

  • Joseph R Hibbeln, MD · LMBB, NIAAA, NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-01
Primary Completion
2016-08-30
Completion
2016-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01901887 on ClinicalTrials.gov