Last reviewed · How we verify
NCT00074503
PET Imaging of DHA Metabolism
trial in Healthy in 85 participants. Completed in 13 July 2010.
Quick facts
| Lead sponsor | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 85 |
| Start date | 12 December 2003 |
| Estimated completion | 13 July 2010 |
| Sites | 1 location across United States |
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Who can join
Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00074503
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00074503 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Last refreshed: 2 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00074503.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing