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NCT00014027 · ClinicalTrials.gov registry record · Phase 1
Effect of Polyunsaturated Fatty Acids on Cardiovascular and Motor Responses Under Stress
A Phase 1 study of Healthy, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
- 1
- Study location
NCT00014027 is a Phase 1 study of Healthy that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 97 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00014027, a Phase 1 study of Healthy, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Docosahexaenoic acid (DHA)
- DRUG Eicosapentaenoic acid
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2001-04-04 |
| Est. Completion | 2008-04-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00014027
The ClinicalTrials.gov registry entry for NCT00014027 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (85% lower). The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Docosahexaenoic acid (DHA) is the first listed.
NCT00014027 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00014027 about?
NCT00014027 is a clinical study titled "Effect of Polyunsaturated Fatty Acids on Cardiovascular and Motor Responses Under Stress". 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...
What is the current status of trial NCT00014027?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2001-04-04. Estimated completion is 2008-04-11.
What conditions does trial NCT00014027 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00014027?
The interventions under investigation include: Docosahexaenoic acid (DHA) (DRUG), Eicosapentaenoic acid (DRUG).
Who is sponsoring clinical trial NCT00014027?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00014027 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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