NCT00074503

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 subject's 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 1-1/2 hours of scanning to measure DHA absorption into the brain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2003

Completed
Same day until next milestone

Study Start

First participant enrolled

December 12, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2003

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2010

Completed
Last Updated

July 2, 2017

Status Verified

July 13, 2010

First QC Date

December 12, 2003

Last Update Submit

June 30, 2017

Conditions

Keywords

Positron Emission TomographyPhospholipidsAlcoholism[11C]Docosahexaenoate[150]WaterBrainFatty AcidsBlood FlowHealthy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years.

You may not qualify if:

  • Any Axis I diagnosis, current or past.
  • History of any intravenous drug use, or a DSM IV diagnosis of drug use or alcohol abuse or dependence.
  • 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.
  • Abnormal laboratory or diagnostic tests that might disturb the dependent measures of the study.
  • Inability to give a clinical history or informed consent.
  • Inability to follow dietary guidelines.
  • Serious medical problems requiring ongoing treatment (i.e., diabetes or hypertension).
  • Positive test for hepatitis C or human immunodeficiency virus (HIV).
  • Metallic foreign bodies lodged in the head or neck that would be affected by the MRI scanner magnet.
  • Head trauma resulting in a period of unconsciousness lasting longer than one hour.
  • History of central nervous system infection.
  • History of fetal alcohol syndrome or other neurodevelopment disorder.
  • History of seizures, other than in childhood and related to fever.
  • 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.
  • Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits of exposure.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Bourre JM, Pascal G, Durand G, Masson M, Dumont O, Piciotti M. Alterations in the fatty acid composition of rat brain cells (neurons, astrocytes, and oligodendrocytes) and of subcellular fractions (myelin and synaptosomes) induced by a diet devoid of n-3 fatty acids. J Neurochem. 1984 Aug;43(2):342-8. doi: 10.1111/j.1471-4159.1984.tb00906.x.

    PMID: 6736955BACKGROUND
  • Salem N Jr, Niebylski CD. The nervous system has an absolute molecular species requirement for proper function. Mol Membr Biol. 1995 Jan-Mar;12(1):131-4. doi: 10.3109/09687689509038508.

    PMID: 7767372BACKGROUND
  • Bourre JM, Francois M, Youyou A, Dumont O, Piciotti M, Pascal G, Durand G. The effects of dietary alpha-linolenic acid on the composition of nerve membranes, enzymatic activity, amplitude of electrophysiological parameters, resistance to poisons and performance of learning tasks in rats. J Nutr. 1989 Dec;119(12):1880-92. doi: 10.1093/jn/119.12.1880.

    PMID: 2576038BACKGROUND

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

December 12, 2003

First Posted

December 15, 2003

Study Start

December 12, 2003

Study Completion

July 13, 2010

Last Updated

July 2, 2017

Record last verified: 2010-07-13

Locations