Status:
COMPLETED
Use Of The Dietary Supplement 5-ALA And Its Relationship With Sleep And Mood
Lead Sponsor:
University of Hawaii
Collaborating Sponsors:
SBI ALApromo Co., Ltd. - Strategic Business Innovator
Conditions:
Insomnia
Nocturnal Awakening
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief 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 sever...
Detailed Description
5-Aminolevulinic Acid (5-ALA) is a dietary supplement and a naturally occurring amino acid. It is a natural delta amino acid; as a non-alpha amino acid, it is not a component of proteins. 5-ALA is syn...
Eligibility Criteria
Inclusion
- Healthy Adults Living On Oahu, Hawaii (or able to personally attend five/1-hour/on-site appointments on Oahu, over a 10 week period)
- No Medication Or Supplements Currently Taken For Sleep Or Mood Adjustments
- Body Weight 110-250 Pounds
- Normal CBC And Ferritin Labwork Done At Screening
- All Participants Self-Reporting Insomnia, Nocturnal Awakening, Difficulty Sleeping/Falling Asleep Or Feeling Moody
Exclusion
- Participants With A History Of Hepatitis, Porphyria, Hemochromatosis, Or Iron Sensitivity
- Participants With Active Liver Disease
- Women Who Are Pregnant Or Breastfeeding
- Participants Currently In Another Clinical Study
- Labwork With Ferritin Levels Elevated Above 125% Of Normal On Screening
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01508741
Start Date
January 1 2012
End Date
December 1 2012
Last Update
March 20 2013
Active Locations (1)
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1
University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine
Honolulu, Hawaii, United States, 96813