Use Of The Dietary Supplement 5-ALA And Its Relationship With Sleep And Mood

Completed · Not applicable · Has a placebo group

Conditions studied: Insomnia, Nocturnal Awakening, Irritability, Coping Behavior, Stress

In brief

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.

Key facts

Study ID

NCT01508741

Run by

University of Hawaii

People needed

85

Starts

2012-01-01

Expected to finish

2012-12-01

Last updated by the study team

2013-03-20

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine — Honolulu, Hawaii, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.