Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014027
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2001-04-07
Brief Title:
Effect of Polyunsaturated Fatty Acids on Cardiovascular and Motor Responses Under Stress
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Polyunsaturated Fatty Acids and the Neurochemistry of Cardiovascular and Behavioral Responses in Aggressive Alcoholics
Status:
COMPLETED
Status Verified Date:
2010-07-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is designed to find out if increasing the dietary intake of polyunsaturated fats improves concentration motor skills and cardiovascular responses under stress These polyunsaturated fats may also change the chemicals in the brain that control these responses Specifically these polyunsaturated fats may raise brain levels of neurotransmitters called dopamine and serotonin Polyunsaturated fats are important for improving the function of both the brain and the heart People cannot make these polyunsaturated fats and they can only be obtained from the oils that we eat For three months subjects will take 8 capsules a day that contain either corn oils flavored with fish oils or fish oil that taste a little like corn oils Subjects will not be told which oils we expect to work better An initial evaluation will determine if subjects fit the criteria necessary to enter the study A battery of tests will be conducted twice once before starting the capsules and again after three months of taking the capsules These batteries of tests will include an MRI of the head paper and pencil tests to evaluate changes in mood and tests of concentration and motor skills and cardiovascular responses under stress Two lumbar punctures will be performed to collect cerebrospinal fluid so that changes in neurotransmitters can be evaluated Subjects will be on a no seafood diet to equalize their dietary intake of polyunsaturated fatty acids Subjects will be expected to complete all parts of this study
Detailed Description:
The central aim of this protocol is to determine if the omega-3 fatty acids eicosapentaenoic acid EPA and docosahexaenoic and DHA reduce aggressive behaviors among alcoholics in a randomized double blind placebo controlled trial Aggression will be measured in a well-established behavioral test the Point Subtraction Aggression Paradigm Secondary and tertiary aims are to determine if supplementation will improve neurochemical mechanisms and cardiovascular abnormalities that are linked to the pathophysiology of aggression A testing battery will be done before supplementation baseline and compared to the same battery repeated after three months of supplementation This battery will include 1 psychometric measures aggression depression and impulsivity 2 a neurochemical measure a lumbar puncture for assessment of cerebrospinal fluid 5-hydroxyindolacetic acid CSF 5-HIAA a metabolite of serotonin and 3 a measure of cardiovascular physiology heart rate variability The research participants will be randomized to consume four 1-gram capsules d containing either 188 grams of DHA plus EPA active or reference oils containing corn oil and 1 fish oil for flavor blinding placebo Research participants will be aggressive recovering alcoholics defined as scoring 20 or more on the Coccaro Lifetime History of Aggression Scale and who eat seafood no more than once per week If these inexpensive nutrients reduce aggression or the related neurochemical and cardiovascular measures these findings will be readily applicable to many aggressive populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-AA-0141 | None | None | None |