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

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.

Conditions

• Insomnia
• Nocturnal Awakening
• Irritability
• Coping Behavior
• Stress

Interventions

DIETARY_SUPPLEMENT

5-Aminolevulinic Acid (5-ALA)

5-ALA 50 mg. p.o. daily capsules taken over 6 weeks.

DIETARY_SUPPLEMENT

Placebo

Daily p.o. capsule of similar shape and color to active ingredient 5-ALA capsule taken over 6 weeks.

Sponsors & Collaborators

• SBI ALApromo Co., Ltd. - Strategic Business Innovator

  collaborator UNKNOWN

• University of Hawaii

  lead OTHER

Principal Investigators

• 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

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2012-10-31

Completion

2012-12-31

Countries

• United States

Study Locations