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

This study has been completed.
Sponsor:
Collaborator:
SBI ALApromo Co., Ltd. - Strategic Business Innovator
Information provided by (Responsible Party):
University of Hawaii
ClinicalTrials.gov Identifier:
NCT01508741
First received: January 9, 2012
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Insomnia
Nocturnal Awakening
Irritability
Coping Behavior
Stress
Dietary Supplement: 5-Aminolevulinic Acid (5-ALA)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: Supplement 5-ALA And Sleep And Mood Study

Resource links provided by NLM:


Further study details as provided by University of Hawaii:

Primary Outcome Measures:
  • 5-ALA Supplementation And Its Relationship To Sleep And Mood [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 85
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 5-Aminolevulinic Acid (5-ALA)
Active component 50 mg. capsules of 5-Aminolevulinic Acid (5-ALA)
Dietary Supplement: 5-Aminolevulinic Acid (5-ALA)
5-ALA 50 mg. p.o. daily capsules taken over 6 weeks.
Other Names:
  • 5-Aminolevulinic Acid
  • 5-ALA
Placebo Comparator: Placebo capsule
Non-active component capsules
Dietary Supplement: Placebo
Daily p.o. capsule of similar shape and color to active ingredient 5-ALA capsule taken over 6 weeks.
Other Name: Placebo

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 synthesized in the mitochondria, and is the first compound in the prophyrin synthesis pathway, the pathway that leads to heme in mammals and chlorophyll in plants. 5-ALA has been associated with genetic information, structure and metabolism, and energy conversion.

5-ALA can be found in many common foods, such as spinach, tomatoes, shitake mushrooms, potatoes, squid, ground beef, wine and soy sauce. The normal intake from food containing 5-ALA is 1-2 mg/day. 5-ALA is synthesized by the body at a rate of 600 mg/day.

Data has supported the hypothesis that supplementation with 5-ALA may be related to improved sleep, mood and coping abilities. This research study will further explore this potential relationship.

The duration of the study for each participant is a total of 10 weeks, which include 4 separate appointments, spaced 3-4 weeks apart. Participants in the Intervention Group will begin taking one daily 50 mg capsule p.o. of 5-ALA over a 6 week period, and the Control Group will be provided with a placebo of similar size and color.

Before entering the research study, each participant undergoes a thorough screening process, including lab work (CBC and Ferritin). Once accepted into the study, the daily capsules are started and a diary is filled out by each participant at home each day and brought to each appointment for review. Instructions are given to record patterns and changes pertaining to sleep, mood or coping abilities. After 6 weeks, the participant is then instructed to stop the daily capsules but to continue daily diary recordings. They are also scheduled for one final appointment at week 10. At each of the 4 appointments over the 10 week period, assessments are performed by health care professionals, questionnaires and daily diaries are reviewed/recorded and anthropometric measurements are obtained.

The product used in this investigation contains 3 components:

  • 5-Aminolevulinic acid (5-ALA) phosphate
  • Sodium Ferrous Citrate (SFC)
  • Corn starch as filler.

The 5-ALA capsules and contents are Non-GMO, BSE free, and alcohol free. The products tested are manufactured under food GMP conditions. A certificate of analysis is available.

Variables monitored as part of the evaluation will be assessed by comparing the intervention group to the control group. Two-sample t-tests will be used to assess statistical significance at baseline and follow-up exams. Baseline data will be summarized as means and standard deviations with differences among the randomized groups tested for significance by t-tests and chi-square tests. To measure the possible differences in rates of change in sleep and mood scores across follow-up time between the 5-ALA treatment and the control group, additional analyses will estimate differences in slopes using linear regression models. Mixed linear models will be fit using the proc mixed procedure in SAS 9.2. The regression models will include an indicator variable identifying treatment groups, a variable for weeks of follow-up, and interaction terms between the indicator variables and follow-up time. Results will be summarized as the difference in slopes comparing the intervention groups to the control group. Results will also be presented graphically to illustrate the estimated differences in slopes for the study groups. All significant tests will be two-sided.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508741

Locations
United States, Hawaii
University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii
SBI ALApromo Co., Ltd. - Strategic Business Innovator
Investigators
Study Chair: Rosanne C. Harrigan, Ed.D. University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine
Principal Investigator: 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
Study Director: Terry Shintani, M.D. University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine
  More Information

No publications provided

Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT01508741     History of Changes
Other Study ID Numbers: CHS-19719
Study First Received: January 9, 2012
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Hawaii:
Insomnia
Frequent Nocturnal Awakening
Irritability
Moody
Moodiness
Coping Ability
Coping Behavior
Stress
Feeling Overwhelmed

Additional relevant MeSH terms:
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 30, 2014