Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074503
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-12-12
Brief Title:
PET Imaging of DHA Metabolism
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Positron Emission Tomography Imaging of Incorporation of Docosahexaenoic Acid DHA From Plasma Into Human Brain
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 study will examine the use of positron emission tomography PET for measuring docosahexaenoic acid DHA absorption from the blood into the brain DHA is a type of fatty acid found in fish and other seafood It is involved in brain cell activity that underlies the ability to think move and respond to the outside world When the amount of DHA in the brain is low the brain may not work the same as if there were a normal amount of DHA If PET can be used successfully to evaluate brain DHA metabolism this method might be useful for future studies of alcoholism since brain DHA levels are influenced by alcohol consumption
Healthy normal volunteers between 18 and 65 years of age may be eligible for this study Because study participants must stop taking any medications including herbal preparations individuals who require regular medication are excluded from this protocol Participants will undergo the following tests and procedures
Psychological questionnaires concerning thoughts and behaviors
Nutritional status analysis A dietitian will assess the subjects nutritional status through questionnaires and measurement of body fat Body fat is measured using bioelectrical impedance analysis This analysis uses a low safe electric current to measure body composition giving a reading of the percentage of fat in the body
Fat biopsy to measure the composition of fat tissue An area on the upper half of the buttock will be numbed and a needle will be inserted to aspirate a sample of fat tissue for analysis
Blood drawing Blood samples will be collected at the time of the fat biopsy and the PET scan see below to measure DHA and indicators that may influence DHA
Diet 3 days before the fat biopsy and at least 3 days before the PET scan subjects will consume a diet low in DHA and other omega-3 fats This no seafood diet prohibits eating fish shellfish seaweed seafood health food products or supplemental vitamins and foods containing canola or flaxseed oil Caffeine-containing beverages are limited to one per day for 3 days before the study Alcoholic beverages are prohibited for 2 weeks before the study For 24 hours before the PET scan subjects eat only standard meals that will be provided to them
Magnetic resonance imaging A brain MRI scan will be done to fit the PET scan images onto a picture of the whole brain During the scan the subject lies on a table inside a narrow metal cylinder containing a strong magnetic field
PET scan Before the PET scan catheters small plastic tubes are inserted into an arm vein and into a wrist artery The venous catheter is used for injecting a radioactive substance that will be detected by the scanner and the arterial catheter is used for collecting blood samples during the scan For the scan the subject lies on a bed that slides into the doughnut-shaped scanner A mask is placed to keep the head still A transmission scan is done to see how much radiation the skull absorbs Radioactive water 15O-water is then injected into the blood and the brain is scanned for about 10 minutes to measure brain blood flow Then radioactive DHA 11C-DHA is injected followed by about 1-12 hours of scanning to measure DHA absorption into the brain
Healthy normal volunteers between 18 and 65 years of age may be eligible for this study Because study participants must stop taking any medications including herbal preparations individuals who require regular medication are excluded from this protocol Participants will undergo the following tests and procedures
Psychological questionnaires concerning thoughts and behaviors
Nutritional status analysis A dietitian will assess the subjects nutritional status through questionnaires and measurement of body fat Body fat is measured using bioelectrical impedance analysis This analysis uses a low safe electric current to measure body composition giving a reading of the percentage of fat in the body
Fat biopsy to measure the composition of fat tissue An area on the upper half of the buttock will be numbed and a needle will be inserted to aspirate a sample of fat tissue for analysis
Blood drawing Blood samples will be collected at the time of the fat biopsy and the PET scan see below to measure DHA and indicators that may influence DHA
Diet 3 days before the fat biopsy and at least 3 days before the PET scan subjects will consume a diet low in DHA and other omega-3 fats This no seafood diet prohibits eating fish shellfish seaweed seafood health food products or supplemental vitamins and foods containing canola or flaxseed oil Caffeine-containing beverages are limited to one per day for 3 days before the study Alcoholic beverages are prohibited for 2 weeks before the study For 24 hours before the PET scan subjects eat only standard meals that will be provided to them
Magnetic resonance imaging A brain MRI scan will be done to fit the PET scan images onto a picture of the whole brain During the scan the subject lies on a table inside a narrow metal cylinder containing a strong magnetic field
PET scan Before the PET scan catheters small plastic tubes are inserted into an arm vein and into a wrist artery The venous catheter is used for injecting a radioactive substance that will be detected by the scanner and the arterial catheter is used for collecting blood samples during the scan For the scan the subject lies on a bed that slides into the doughnut-shaped scanner A mask is placed to keep the head still A transmission scan is done to see how much radiation the skull absorbs Radioactive water 15O-water is then injected into the blood and the brain is scanned for about 10 minutes to measure brain blood flow Then radioactive DHA 11C-DHA is injected followed by about 1-12 hours of scanning to measure DHA absorption into the brain
Detailed Description:
Docosahexaenoic acid DHA 226 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 A2-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
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 |
|---|---|---|---|
| 04-AA-0058 | None | None | None |