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

NCT01508741 | Completed DMC

• 1 other identifier: CHS-19719
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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 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

Keywords

Insomnia; Frequent Nocturnal Awakening; Irritability; Moody; Moodiness; Coping Ability; Coping Behavior; Stress; Feeling Overwhelmed

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

5-Aminolevulinic Acid (5-ALA)

ACTIVE COMPARATOR

Active component 50 mg. capsules of 5-Aminolevulinic Acid (5-ALA)

Dietary Supplement: 5-Aminolevulinic Acid (5-ALA)

Placebo capsule

PLACEBO COMPARATOR

Non-active component capsules

Dietary Supplement: Placebo

Interventions

5-Aminolevulinic Acid (5-ALA) DIETARY_SUPPLEMENT

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

Also known as: 5-Aminolevulinic Acid, 5-ALA

5-Aminolevulinic Acid (5-ALA)

Placebo DIETARY_SUPPLEMENT

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

Placebo capsule

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Hawaii: lead
• SBI ALApromo Co., Ltd. - Strategic Business Innovator: collaborator

Study Sites (1)

University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Rosanne C. Harrigan, Ed.D.

  University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

• Terry Shintani, M.D.

  University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 12, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

US (1)