Positron Emission Tomography Imaging of Incorporation of Docosahexaenoic Acid (DHA) From Plasma Into Human Brain
Data Collection
Summary
Study start date: December 12, 2003
Actual date on which the first participant was enrolled.Docosahexaenoic acid (DHA, 22:6 n-3) is an essential omega-3 fatty acid that is selectively concentrated in the brain. Epidemiologic studies suggest that DHA deficiency is related to affective disorders, while clinical studies suggest that DHA is efficacious in treating depression. DHA has also been shown to be an important second messenger involved in phospholipase A(2)-mediated signal transduction. Although animal studies have provided a wealth of knowledge about the role of DHA in neural function, no method exists of evaluating DHA content or metabolism in the living human brain. Our goal is to establish a quantitative method of examining brain DHA metabolism using PET in healthy humans and to measure regional DHA incorporation from plasma into the brain. Utilizing the data from the pilot phase with healthy volunteers, we will apply the method to study DHA metabolism in alcoholics. Since alcohol consumption depletes brain DHA, we hypothesize that compared to healthy volunteers; alcoholics will have a decreased rate of incorporation of DHA from plasma into brain. Utilizing the method we have established, we anticipate that we will find previously undetectable metabolic abnormalities in alcoholics. We may further find that such abnormalities are correlated with cognitive or behavioral function. Now that the pilot phase of the protocol has been completed, we are proceeding with the main phase of the protocol to study non-smoking chronic alcoholics.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.85 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
* INCLUSION CRITERIA: Age 18-65 years. EXCLUSION CRITERIA: 1. Any Axis I diagnosis, current or past. 2. History of any intravenous drug use, or a DSM IV diagnosis of drug use or alcohol abuse or dependence. 3. Recent use (within the past two weeks) of alcohol, or any period of extensive use, defined as an average of one standard drink per day over a twelve-month period. 4. Abnormal laboratory or diagnostic tests that might disturb the dependent measures of the study. 5. Inability to give a clinical history or informed consent. 6. Inability to follow dietary guidelines. 7. Serious medical problems requiring ongoing treatment (i.e., diabetes or hypertension). 8. Positive test for hepatitis C or human immunodeficiency virus (HIV). 9. Metallic foreign bodies lodged in the head or neck that would be affected by the MRI scanner magnet. 10. Head trauma resulting in a period of unconsciousness lasting longer than one hour. 11. History of central nervous system infection. 12. History of fetal alcohol syndrome or other neurodevelopment disorder. 13. History of seizures, other than in childhood and related to fever. 14. Nursing women, women with a positive pregnancy test or women of childbearing age who are not willing to use some form of birth control during the study. 15. Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits of exposure. 16. Current use of cigarettes, cigars, or other form of tobacco, defined as ten cigarettes, two pipes or two cigars over the preceding month. 17. Current drug or medication use, or the use of any medication (i.e., Tylenol) for three days prior to PET. 18. Positive urine drug screen. 19. Psychotropic medication use (including benzodiazepines and illicit drugs) during the two weeks prior to the PET scan. The use of medication with a very long half life (i.e., Prozac) during the six weeks prior to the PET scan.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesSee the location