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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: Completed NA study, sponsored by University of Hawaii.
NCT01508741 is a NA study that has completed, run by University of Hawaii. The registered enrollment target is 85 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patterns relating to sleep and mood will be recorded each day of the study by each participant over a 10 week period. This study is conducted to determine if a daily 50 mg p.o. intake of 5-ALA reveals a relationship of improvement regarding patterns of sleep or mood.
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 |
What the finished NCT01508741 record still lists
NCT01508741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01508741 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01508741's enrollment target sits among peer trials
85 980th of 2000 higher than 1,018 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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