InsomniaNCT01508741
Use Of The Dietary Supplement 5-ALA And Its Relationship With Sleep And Mood
A study testing 5-Aminolevulinic Acid (5-ALA) in people with Insomnia and Nocturnal Awakening, run by University of Hawaii at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Nocturnal Awakening, Irritability
- What is being tested?
- 5-Aminolevulinic Acid (5-ALA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine
Honolulu, Hawaii, 96813
About this study
Official title: Supplement 5-ALA And Sleep And Mood Study
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.
Read more
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.
Read the 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.
- Conditions
- Insomnia, Nocturnal Awakening, Irritability, Coping Behavior, Stress
- Being tested
- 5-Aminolevulinic Acid (5-ALA), Placebo
- Keywords
- Insomnia, Frequent Nocturnal Awakening, Irritability, Moody, Moodiness, Coping Ability, Coping Behavior, Stress, Feeling Overwhelmed
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Aminolevulinic Acid (5-ALA)Dietary supplement
Also called 5-Aminolevulinic Acid, 5-ALA
5-ALA 50 mg. p.o. daily capsules taken over 6 weeks.
PlaceboDietary supplement
Daily p.o. capsule of similar shape and color to active ingredient 5-ALA capsule taken over 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 5-Aminolevulinic Acid (5-ALA) | Active comparator | Active component 50 mg. capsules of 5-Aminolevulinic Acid (5-ALA) Receives: Dietary Supplement: 5-Aminolevulinic Acid (5-ALA) |
| Placebo capsule | Placebo comparator | Non-active component capsules Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- SBI ALApromo Co., Ltd. - Strategic Business Innovator
- Responsible party
- Sponsor
- Investigators
- Rosanne C. Harrigan, Ed.D., Study chair, University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative MedicineBeatriz L. Rodriguez, M.D., Principal investigator, University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine and Dept. of Geriatric MedicineTerry Shintani, M.D., Study director, University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508741
- Sponsor's protocol ID
- CHS-19719
- Status last verified
- Mar 2013
- First submitted
- 9 Jan 2012
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplement 5-ALA And Sleep And Mood Study
- ClinicalTrials.gov ID
- NCT01508741
- Acronym / sponsor ID
- CHS-19719
- Conditions
- Insomnia, Nocturnal Awakening, Irritability, Coping Behavior, Stress
- Keywords
- Insomnia, Frequent Nocturnal Awakening, Irritability, Moody, Moodiness, Coping Ability, Coping Behavior, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- SBI ALApromo Co., Ltd. - Strategic Business Innovator
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-Aminolevulinic Acid (5-ALA) | Active comparator | Dietary Supplement: 5-Aminolevulinic Acid (5-ALA)Active component 50 mg. capsules of 5-Aminolevulinic Acid (5-ALA) |
| Placebo capsule | Placebo comparator | Dietary Supplement: PlaceboNon-active component capsules |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-Aminolevulinic Acid (5-ALA)Also: 5-Aminolevulinic Acid, 5-ALA5-ALA 50 mg. p.o. daily capsules taken over 6 weeks. | Dietary supplement | 5-Aminolevulinic Acid (5-ALA) |
| PlaceboDaily p.o. capsule of similar shape and color to active ingredient 5-ALA capsule taken over 6 weeks. | Dietary supplement | Placebo capsule |
Primary outcome
5-ALA Supplementation And Its Relationship To Sleep And Mood
Time frame: 10 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosanne C. Harrigan, Ed.D. study chair
University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine
Beatriz L. Rodriguez, M.D. principal investigator
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. study director
University of Hawaii at Manoa, John A. Burns School of Medicine, Dept. of Complementary and Alternative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-Aminolevulinic Acid (5-ALA) in people with Insomnia and Nocturnal Awakening, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-ALA Supplementation And Its Relationship To Sleep And Mood (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.