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NCT01508741 · ClinicalTrials.gov registry record · NA
Use Of The Dietary Supplement 5-ALA And Its Relationship With Sleep And Mood
A NA study, sponsored by University of Hawaii.
- Completed
- Registry status
- NA
- Development phase
- 85
- Enrollment target
NCT01508741 is a NA study that has completed, run by University of Hawaii. The registered enrollment target is 85 participants.
The verdict
NCT01508741, a NA study, has completed, sponsored by University of Hawaii.
- COMPLETED
- Registry status
- NA
- Development phase
- 85 participants
- Enrollment target
Study Summary
PURPOSE: The purpose of this investigation is to determine if a relationship exists between the administration of a dietary supplement containing 5-ALA and sleep and mood. HYPOTHESIS: There are several possible mechanisms for improvement in sleep and mood. In one study involving test mice, researchers found that the regular administration of 5-ALA appeared to raise serotonin levels in the brain. One hypothesis is by increasing serotonin levels, 5-ALA may contribute to improvements with sleep, along with additional improvements in mood, calmness, irritability and coping abilities. 5-ALA may also support hormonal regulation, including melatonin, in the pineal gland and corticosteroid regulation in the adrenal glands. Another hypothesis is that 5-ALA may have an impact on increasing the energy and metabolism of cells, such that its own circadian rhythms are better defined. 5-ALA may support neuronal function and assistance with "mental energy" needed to deal with stress in daily life, producing better feelings of "coping", "less irritability" and lowering an individual's feelings of "fatigue", all of which may contribute to a reduction of "pessimism" regarding the ability to deal with daily tasks. DESIGN: This will be a double-blinded, randomized parallel-group comparison study. SAMPLE: 40 participants will be randomized to the following 2 study groups for each outcome variable (Sleep and Mood): Control Group - 20 participants and Intervention Group - 20 participants. A table of random numbers will be used to assign the participants.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT 5-Aminolevulinic Acid (5-ALA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01508741
The ClinicalTrials.gov registry entry for NCT01508741 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Hawaii, which has 77 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01508741 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01508741 about?
NCT01508741 is a clinical study titled "Use Of The Dietary Supplement 5-ALA And Its Relationship With Sleep And Mood". PURPOSE: The purpose of this investigation is to determine if a relationship exists between the administration of a dietary supplement containing 5-ALA and sleep and mood. HYPOTHESIS: There are several possible mechanisms for improvement in sleep and mood. In one study involving test mice, research...
What is the current status of trial NCT01508741?
This trial is currently completed. It is a NA study. The enrollment target is 85 participants. The study started on 2012-01. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01508741?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), 5-Aminolevulinic Acid (5-ALA) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01508741?
This trial is sponsored by University of Hawaii, which has 77 total clinical trials registered on ClinicalTrials.gov.
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