| Conditions: |
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Insomnia - Nocturnal Awakening - Irritability - Coping Behavior - Stress |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01508741 |
| Primary Contact: |
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Study Chair
Rosanne C. Harrigan, Ed.D.
University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternat
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| Backup Contact: |
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N/A |
| Location Contact: |
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Honolulu, Hawaii 96813
United States
There is no listed contact information for this specific location.
Site Status: N/A |