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Supplement 5-ALA And Sleep And Mood Study
Sponsor study identifier
interventional
85
1 country
1
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
December 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
January 9, 2012
Actual (reported)January 12, 2012
Actual (reported)October 2012
Actual (reported)December 2012
Actual (reported)5-ALA Supplementation And Its Relationship To Sleep And Mood
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.
10 weeks
Active component 50 mg. capsules of 5-Aminolevulinic Acid (5-ALA)
Non-active component capsules
5-ALA 50 mg. p.o. daily capsules taken over 6 weeks.
Daily p.o. capsule of similar shape and color to active ingredient 5-ALA capsule taken over 6 weeks.
University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine
Honolulu, Hawaii, 96813, United States
Rosanne C. Harrigan, Ed.D.
University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine
Beatriz L. Rodriguez, M.D.
University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine and Dept. of Geriatric Medicine
Terry Shintani, M.D.
University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine
85 participants (actual enrollment reported by the registry).
First Submitted
January 9, 2012
First Posted
January 12, 2012
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
March 20, 2013
Record last verified: 2013-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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